The document discusses regulatory environment and clinical trials in South East Asia. It provides information on:
1) The regulatory environment and drug registration processes vary across countries in the region but are becoming more harmonized through ASEAN initiatives. Requirements like GMP certificates and CPPs from countries of origin are common.
2) Approval timelines for new drug registration range from 6-24 months depending on the country. Singapore and Thailand typically approve within 6-12 months while Indonesia, Philippines, and Malaysia may take 12-24 months.
3) Clinical trial activity is growing in the region as large pharmaceutical companies conduct multi-center global trials to achieve faster patient recruitment for drug development. The large patient pools in
This document provides information on registering clinical trials in the Clinical Trials Registry - India (CTRI). It explains that the CTRI is a free, online system for registering all clinical trials conducted in India. Registration is mandatory per the Drugs Controller General (India) and provides transparency. The document outlines the CTRI registration process, including obtaining a username and password, entering trial details online, verification by CTRI, and being assigned a registration number. Key trial details that must be included are described.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
This document discusses the key differences between CDSCO-GCP guidelines. It covers 7 sections: definitions of good clinical practice; pre-requisites for clinical trials; responsibilities of sponsors, monitors and investigators; documentation and validation of electronic data; quality assurance systems; statistical analysis plans; and special concerns for certain types of clinical trials like vaccines, contraceptives and herbal remedies. The overall purpose is to outline the guidelines for designing, conducting and reporting clinical research studies involving human subjects.
Clinical Research Training - Dr Ruben Keane, UCC - Dec 7th 2016 ipposi
This document discusses current and future regulatory requirements for clinical trials in Ireland and Europe. Currently, clinical trials require approval from a research ethics committee and the Health Products Regulatory Authority. Substantial amendments and safety reporting are also regulated. The EU is introducing a new Clinical Trials Regulation that will streamline the approval process across countries using a single application system and coordinated review. This aims to increase harmonization, transparency and efficiency of conducting multinational clinical trials in Europe. Key details around implementing the new system in Ireland are still to be determined.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
This document provides information on registering clinical trials in the Clinical Trials Registry - India (CTRI). It explains that the CTRI is a free, online system for registering all clinical trials conducted in India. Registration is mandatory per the Drugs Controller General (India) and provides transparency. The document outlines the CTRI registration process, including obtaining a username and password, entering trial details online, verification by CTRI, and being assigned a registration number. Key trial details that must be included are described.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
This document discusses the key differences between CDSCO-GCP guidelines. It covers 7 sections: definitions of good clinical practice; pre-requisites for clinical trials; responsibilities of sponsors, monitors and investigators; documentation and validation of electronic data; quality assurance systems; statistical analysis plans; and special concerns for certain types of clinical trials like vaccines, contraceptives and herbal remedies. The overall purpose is to outline the guidelines for designing, conducting and reporting clinical research studies involving human subjects.
Clinical Research Training - Dr Ruben Keane, UCC - Dec 7th 2016 ipposi
This document discusses current and future regulatory requirements for clinical trials in Ireland and Europe. Currently, clinical trials require approval from a research ethics committee and the Health Products Regulatory Authority. Substantial amendments and safety reporting are also regulated. The EU is introducing a new Clinical Trials Regulation that will streamline the approval process across countries using a single application system and coordinated review. This aims to increase harmonization, transparency and efficiency of conducting multinational clinical trials in Europe. Key details around implementing the new system in Ireland are still to be determined.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
Clinical trials provide benefits to patients, investigators, hospitals, and companies. However, Ireland is conducting fewer trials each year due to roadblocks to investment like non-adherence to legislation, administrative barriers, and delays. These issues are causing Ireland to lose millions annually to other countries that are eager to receive clinical trials. Adherence to legislation, timelines, and focus on innovation are keys to ensuring clinical trials remain in Ireland.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
The document discusses the EMA inspection process, including types of inspections, definitions, procedures, timelines, and expectations. It provides details on systems inspections, study specific inspections, inspection reasons, definitions, procedures, timelines, dossier requests, site selection, inspection selection, and the general inspection process.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
The document summarizes the functions and initiatives of the Central Drugs Standard Control Organization (CDSCO) in India. CDSCO regulates drug approval, clinical trials, and drug imports. It has strengthened regulations through new posts, international collaborations, overseas inspections, banning drugs, promoting generics, and strengthening clinical trial oversight. CDSCO also oversees the Pharmacovigilance Programme of India to monitor drug safety. The document outlines the phases of clinical drug trials and ethical guidelines for research involving human subjects in India.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
This document discusses pharmaceutical regulations and their impact on ensuring sterility and quality control. It addresses how strict definitions of sterility are defined quantitatively in terms of probability of a non-sterile unit. Proper management of aseptic processing areas and personnel training are essential to maintaining sterility. Inspectors focus on facilities, equipment, materials, and documentation to ensure quality management systems prevent inferior products. Sources of particulate contamination include environmental factors, packaging materials, product interactions, and process issues. Intravenous administration of particulates carries the highest risk, as particles can disseminate throughout the body and block vessels. Large particle loads, irregular shapes, and vulnerable patient populations increase risks of adverse effects.
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
Regulatory Highlights and Drug Development in ChinaMedpace
Regulatory Highlights and Drug Development in China was presented at the 5th China Clinical Trials Outsourcing Congress March 4-5, 2013 by Xiaoxiong (Jim) Wei, MD, PhD, Medical Director at Medpace.
Global Clinical Trials (GCT) is a full-service CRO that has conducted clinical trials in Central and Eastern Europe since 2001. It has offices in multiple countries and provides services including regulatory support, translation, monitoring, and storage facilities. GCT offers advantages such as fast enrollment, competitive costs at 40% lower than US trials, therapeutic expertise, and a strong reputation demonstrated by FDA approval of drugs tested in its regions. GCT aims to deliver high quality and compliant trials on time through an experienced team of physician staff.
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This document summarizes the regulation of cell and tissue therapies and clinical research in Australia. It discusses that biologicals include cell and tissue therapy products and are regulated based on their risk classification. Biologicals are grouped into four classes depending on how manipulated they are from their natural state and how closely their use matches the natural biological function. The regulatory process for including biologicals in the Australian Register of Therapeutic Goods involves evaluation of quality, safety and efficacy data by scientists and clinicians. Clinical trials of biologicals must be notified or exempted and evaluated for safety considerations. Post-market monitoring includes mandatory adverse event reporting to the Therapeutic Goods Administration.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
TGA Presentation: Data Metrics and Current Inspection TrendsTGA Australia
The document discusses current inspection trends and data metrics from the Therapeutic Goods Administration (TGA) in Australia. It provides compliance ratings for domestic and overseas inspections from 2010-2016, showing most inspections receive an A1 or A2 rating. For 2016, the most common deficiencies related to poor investigations, automated systems, validation, procedures, and quality control. Specific issues for sterile and API manufacturers are also summarized.
How do listed medicines shape up in the post market compliance spaceTGA Australia
This presentation provides an overview of the TGA’s post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.
The document discusses Thailand's drug registration and control system. It provides details on:
1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance.
2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality.
3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues.
4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and
This document discusses the clinical research environment and opportunities in Asia, specifically Taiwan. It notes that Asia is now the fastest growing market for drug development and offers the lowest costs for clinical trials worldwide. Taiwan has a strong clinical research environment supported by English medical documentation and an improving regulatory system. The large and diverse patient populations in Asia also provide significant opportunities for patient recruitment into clinical trials. Overall, Asia and countries like Taiwan, South Korea, and China present advantages for clinical research including lower costs and large patient pools that make them attractive locations for global drug companies to conduct clinical trials.
TGA presentation: Data Integrity - an international regulatory perspectiveTGA Australia
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview of the regulation of autologous cells and tissues in Australia, including a discussion on emerging examples of practices that have the potential for increased risk.
Clinical trials provide benefits to patients, investigators, hospitals, and companies. However, Ireland is conducting fewer trials each year due to roadblocks to investment like non-adherence to legislation, administrative barriers, and delays. These issues are causing Ireland to lose millions annually to other countries that are eager to receive clinical trials. Adherence to legislation, timelines, and focus on innovation are keys to ensuring clinical trials remain in Ireland.
Presentation: IGDRP - Mission, scope, how it worksTGA Australia
This presentation provides an overview of the International Generic Drug Regulators Programme (IGDRP), its conception including its mission and objectives, and the activities of its various working group and its future.
The document discusses the EMA inspection process, including types of inspections, definitions, procedures, timelines, and expectations. It provides details on systems inspections, study specific inspections, inspection reasons, definitions, procedures, timelines, dossier requests, site selection, inspection selection, and the general inspection process.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices. It is responsible for approving new drugs, licensing manufacturing facilities, and monitoring drug quality. CDSCO's vision is to protect and promote public health in India. It has headquarters in New Delhi and offices across India. CDSCO regulates clinical trials, biosimilars, medical devices, and investigational new drugs. It also oversees state licensing authorities and provides guidance on drug regulation.
The document summarizes the functions and initiatives of the Central Drugs Standard Control Organization (CDSCO) in India. CDSCO regulates drug approval, clinical trials, and drug imports. It has strengthened regulations through new posts, international collaborations, overseas inspections, banning drugs, promoting generics, and strengthening clinical trial oversight. CDSCO also oversees the Pharmacovigilance Programme of India to monitor drug safety. The document outlines the phases of clinical drug trials and ethical guidelines for research involving human subjects in India.
Presentation: Transparency initiatives and the TGATGA Australia
This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.
This document discusses pharmaceutical regulations and their impact on ensuring sterility and quality control. It addresses how strict definitions of sterility are defined quantitatively in terms of probability of a non-sterile unit. Proper management of aseptic processing areas and personnel training are essential to maintaining sterility. Inspectors focus on facilities, equipment, materials, and documentation to ensure quality management systems prevent inferior products. Sources of particulate contamination include environmental factors, packaging materials, product interactions, and process issues. Intravenous administration of particulates carries the highest risk, as particles can disseminate throughout the body and block vessels. Large particle loads, irregular shapes, and vulnerable patient populations increase risks of adverse effects.
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
Regulatory Highlights and Drug Development in ChinaMedpace
Regulatory Highlights and Drug Development in China was presented at the 5th China Clinical Trials Outsourcing Congress March 4-5, 2013 by Xiaoxiong (Jim) Wei, MD, PhD, Medical Director at Medpace.
Global Clinical Trials (GCT) is a full-service CRO that has conducted clinical trials in Central and Eastern Europe since 2001. It has offices in multiple countries and provides services including regulatory support, translation, monitoring, and storage facilities. GCT offers advantages such as fast enrollment, competitive costs at 40% lower than US trials, therapeutic expertise, and a strong reputation demonstrated by FDA approval of drugs tested in its regions. GCT aims to deliver high quality and compliant trials on time through an experienced team of physician staff.
Regulation of cell and tissue therapies and clinical research in AustraliaTGA Australia
This document summarizes the regulation of cell and tissue therapies and clinical research in Australia. It discusses that biologicals include cell and tissue therapy products and are regulated based on their risk classification. Biologicals are grouped into four classes depending on how manipulated they are from their natural state and how closely their use matches the natural biological function. The regulatory process for including biologicals in the Australian Register of Therapeutic Goods involves evaluation of quality, safety and efficacy data by scientists and clinicians. Clinical trials of biologicals must be notified or exempted and evaluated for safety considerations. Post-market monitoring includes mandatory adverse event reporting to the Therapeutic Goods Administration.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
TGA Presentation: Data Metrics and Current Inspection TrendsTGA Australia
The document discusses current inspection trends and data metrics from the Therapeutic Goods Administration (TGA) in Australia. It provides compliance ratings for domestic and overseas inspections from 2010-2016, showing most inspections receive an A1 or A2 rating. For 2016, the most common deficiencies related to poor investigations, automated systems, validation, procedures, and quality control. Specific issues for sterile and API manufacturers are also summarized.
How do listed medicines shape up in the post market compliance spaceTGA Australia
This presentation provides an overview of the TGA’s post-market compliance program and how data from the program is used to manage non-compliance and highlight areas of concern.
The document discusses Thailand's drug registration and control system. It provides details on:
1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance.
2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality.
3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues.
4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and
This document discusses the clinical research environment and opportunities in Asia, specifically Taiwan. It notes that Asia is now the fastest growing market for drug development and offers the lowest costs for clinical trials worldwide. Taiwan has a strong clinical research environment supported by English medical documentation and an improving regulatory system. The large and diverse patient populations in Asia also provide significant opportunities for patient recruitment into clinical trials. Overall, Asia and countries like Taiwan, South Korea, and China present advantages for clinical research including lower costs and large patient pools that make them attractive locations for global drug companies to conduct clinical trials.
The document discusses Thailand's drug control and registration system. It provides details on the organization and responsibilities of key agencies like the Ministry of Public Health and Food and Drug Administration. It also summarizes Thailand's drug licensing process, registration system for new and generic drugs, safety monitoring programs, and efforts to harmonize standards with ASEAN countries. The document aims to provide an overview of Thailand's regulatory framework and approval processes for drugs.
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
The document discusses regulatory requirements for clinical trials and new drug approval. It outlines the importance of laws and regulations in drug development based on past tragedies. Key events that led to stricter regulations are described, such as the Elixir Sulfanilamide mass poisoning in 1937 and the thalidomide birth defect crisis in the 1960s. The roles and responsibilities of regulatory authorities, pharmaceutical companies, and regulatory affairs departments are explained in relation to bringing a new drug safely to market. Clinical trial phases and requirements for Investigational New Drug applications to the FDA are summarized.
Schedule Y outlines the requirements and guidelines for permission to import and manufacture new drugs in India and to conduct clinical trials. It aims to regulate clinical research and new drugs. Permission is required from the Central Drugs Standard Control Organization and Drugs Technical Advisory Board for importing or manufacturing new drugs as well as conducting clinical trials. Applications must include chemical, pharmaceutical, pre-clinical, and clinical data. Clinical trials must be approved by licensing authorities and ethics committees and informed consent is required. Sponsors and investigators have responsibilities to patients' rights and safety. Trials progress through Phases I-IV and special studies on populations like geriatrics are addressed along with post-marketing surveillance. Detailed appendices provide guidelines on submitting applications and
This document summarizes drug regulation in Thailand. It provides an overview of the Bureau of Drug Control, which regulates drugs in Thailand. It describes the laws and regulations around drug registration in Thailand. The drug registration process is outlined, including definitions of new and generic drugs. Harmonization with ASEAN requirements is discussed, and the new drug review process and approval types are summarized.
This document discusses Good Laboratory Practice (GLP) regulations, which were established in the 1970s in response to malpractice in research and development. GLP regulations set standards for properly managing and organizing studies to generate regulatory data. The key points of GLP include ensuring adequate resources, characterizing test materials, following study plans and procedures, maintaining raw data and final reports, and implementing quality assurance programs. The Organization for Economic Cooperation and Development (OECD) later published GLP Principles that were adopted by its member states.
The document discusses the status and prospects of China's Licensed Pharmacist Qualification System. It provides a general introduction to the system, including its development, management structure, examination process, registration requirements, and the roles and responsibilities of licensed pharmacists. It then compares key differences between China's system and that of the US. Finally, it outlines the future prospects of the system in China as the economy develops and public demand for healthcare increases.
The document summarizes regulatory affairs for the MHRA and USFDA. It discusses the history and roles of the MHRA in regulating clinical trials, licensing products, and enforcing regulations in the UK. It then outlines the development process for new drugs from discovery through licensing. Finally, it provides an introduction to the USFDA, covering its definition, history, mission, organization, functions, and products regulated.
The document provides information on Malaysia's drug approval system. It discusses the National Pharmaceutical Regulatory Agency (NPRA) which ensures the quality, safety and efficacy of medicines through registration and licensing. The registration process for new drug products, generics, biologics and other product types is outlined. Guidelines and requirements for registration include Good Manufacturing Practice standards and ASEAN Common Technical Dossiers. Alternative pathways like priority review, conditional registration and facilitated registration are available to expedite approval of certain products. Statistics on registered manufacturers, importers, wholesalers, products and notified cosmetics in Malaysia are also presented.
Good clinical practices tutorial- v7.015--shehnaz_june-10_v 3.0Shehnaz Vakharia
- The document discusses regulatory issues related to conducting clinical trials in India, including the regulatory framework, applicable local regulations, advantages of conducting trials in India, and key challenges.
- Some advantages include reasonable regulatory approvals, high incidence of diseases common in Western countries, large treatment-naïve populations, and English as the primary business language.
- However, challenges include a shortage of GCP-trained investigators, documentation practices like back-dating records, busy investigator schedules, and variable infrastructure across sites.
This document provides an overview of Good Laboratory Practice (GLP) regulations. It discusses how GLP was created by the FDA in 1978 and adopted as international standards by the OECD. GLP aims to ensure safety study data quality and integrity by providing a framework for how studies should be planned, performed, monitored, and reported. The document reviews key GLP requirements such as management responsibility, personnel qualifications, facilities and equipment, standard operating procedures, quality assurance programs, and archiving study records. It emphasizes how following GLP principles helps to ensure internationally accepted non-clinical safety studies.
Asia Pacific Economic Cooperation (APEC) Role in Pharmaceutical RegulationTarif Hussian
This document discusses Asia-Pacific Economic Cooperation (APEC) and its role in regulatory harmonization for pharmaceuticals. It contains the following key points:
1. APEC aims to facilitate economic growth, cooperation, trade and investment in the Asia-Pacific region, with 21 member economies. It established goals in 1994 to achieve free trade by 2010/2020.
2. APEC addresses regulatory harmonization through the Life Sciences Innovation Forum and Regulatory Harmonization Steering Committee, with a vision for maximum convergence by 2020.
3. Areas of focus include appropriate use of the Certificate of Pharmaceutical Product, PIC/S membership, management of multiple sites, and risk-based evaluation. The
This document provides an overview of regulatory requirements for pharmaceutical products in Rest of World (ROW) countries. It discusses the importance of harmonization and divides pharmaceutical markets into regulated, semi-regulated, and emerging categories. The key registration requirements for ROW countries are outlined, including administrative documents, chemistry and manufacturing controls, stability data, and other documentation. Common deficiencies seen in dossiers for ROW countries are also summarized, such as incomplete stability studies or missing specifications. The conclusion emphasizes that properly planned product development can help generate high-quality dossiers for ROW market registration.
Schedule Y provides requirements and guidelines for permission to import and manufacture new drugs for sale or to undertake clinical trials in India. It outlines the application process and requirements, including pre-clinical data that must be submitted. It describes the responsibilities of sponsors, investigators, and ethics committees for clinical trials. Clinical trials must progress through Phases I-IV and special population studies may be required. Post-marketing surveillance is also addressed. The purpose is to regulate new drugs and ensure clinical research is properly conducted according to good clinical practice standards.
The document discusses Good Laboratory Practices (GLP), which are standards that provide a framework for conducting and reporting laboratory studies. It notes that GLP was developed in response to cases of fraud and poor practices found by the FDA in the 1970s. Key aspects of GLP include standardized operating procedures, trained personnel, appropriate facilities and equipment, meticulous record-keeping, and reporting of study results. GLP is intended to ensure reliability and integrity of nonclinical safety data submitted to regulatory authorities.
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In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
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TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Chapters Download Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Download Stuvia Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Study Guide Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Ebook Download Stuvia Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Questions and Answers Quizlet Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Studocu Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Quizlet Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Chapters Download Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Download Course Hero Community and Public Health Nursing: Evidence for Practice 3rd Edition Answers Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Ebook Download Course hero Community and Public Health Nursing: Evidence for Practice 3rd Edition Questions and Answers Community and Public Health Nursing: Evidence for Practice 3rd Edition Studocu Community and Public Health Nursing: Evidence for Practice 3rd Edition Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Pdf Chapters Download Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Pdf Download Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Study Guide Questions and Answers Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Ebook Download Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Questions Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Studocu Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Stuvia
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Regulatory enviroment and clinical trials in south east asia
1. Ellick Wong/ Regulatory environment and clinical trials in SEA - 1 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Regulatory Environment and Clinical Trials in South East Asia
Ellick Wong PhD
Vice President
Pharmaceutical Development Centre
Pharmacia Corp.
SINGAPORE
Abstract
South East Asia is a growing pharmaceutical market. The regulatory environment has
similar characteristics but drug registration requirements and processes differ among the
countries. An ASEAN initiative to harmonize the requirements for drug registration is
in progress. Many multi-national research-based pharmaceutical companies have begun
to conduct multi-center trials in their global drug development programs involving
Asian medical centers for faster patient recruitment to achieve faster drug development.
In the recent years, there is a steady increase in clinical trial activities in South East Asia.
Key words
Regulatory, drug registration, clinical trial, South East Asia, ASEAN
Introduction
The Association of Southeast Asian Nations (ASEAN) is a growing region in
South East Asia (SE Asia) with 10 member countries namely, Indonesia,
Malaysia, Philippines, Singapore, Thailand, Brunei Darussalam, Vietnam, Laos,
Myanmar and Cambodia. The ASEAN region has a population of about 500
million, a total area of 4.5 million square kilometers, a combined gross domestic
product of US$737 billion, and a total trade of US$ 720 billion. The
pharmaceutical market in SE Asia is relatively small but the region remains
attractive to the pharmaceutical industry due to its growth potentials. Among the
ten ASEAN members, the five founding member countries (Singapore, Malaysia,
Thailand, Philippines & Indonesia) are more progressive with drug registration
and drug development clinical trial activities. This review will therefore confine
the discussion on the regulatory environment, drug registration and clinical trial
developments in the 5 countries. Some key demographic and economic
performance figures for the countries are given in Table 1.
2. Ellick Wong/ Regulatory environment and clinical trials in SEA - 2 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Table 1. South East ASIA
1,025
27.0%
1.062
9.7%
780
2.0%
308
2.3%
241
3.4%
Pharma Market (MUSD)
Y2001
Growth Rate
(2001/2000) LCD
730
2.5%
953
3.9%
1,950
3.0%
3,840
4.5%
27,350
5.0%
GDP/head (USD)
Growth Rate (2002)
209.678.462.423.84.0Population (Million)
IndonesiaPhilippinesThailandMalaysiaSingapore
Countries
Source : ECN, IMS
Regulatory Environment in SE Asia
The regulatory environment in the SE Asian countries has certain features that
are similar but, in general, there are differences in systems and practices. The
characteristics of the regulatory environment are listed in Table 2. Many of the
regulatory agencies in the countries suffer from having rather weak
infrastructures primarily due to limited human resources. Some of the agencies
have less than five staff in handling the registration matters of new drugs. As a
result, the agencies traditionally performed mainly administrative work and simply
endorse approvals of new drugs after other so-call advanced countries have
previously approved them. This has set the scene for the existing approval
systems in these counties relying heavily on the Free Sales Certificate or
Certificate of Pharmaceutical Product (CPP) issued by reference or advanced
countries for registration of new drugs.
Although there appears to be a lack of available scientific guidelines and very few
of them have been established in the region, the ICH guidelines are well adapted
in most countries. Most countries still have the problem of lack of consistency
and transparency in the review procedure. In some countries we see
improvement as more direct communications are becoming possible between
regulator and the industry. The requirement of CPP from country of origin (COO)
still remains a key barrier to the registration of new drugs in the region.
3. Ellick Wong/ Regulatory environment and clinical trials in SEA - 3 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Table 2. Regulatory Environment S.E. Asia
Regulatory agencies: relatively weak infrastructure,
small resources, structurally different
Diversity of regulatory processes / requirements
Diversity of approval timelines
Standards of scientific guidelines not well-established
Lack of consistency & transparency but improving with
more dialogues with industry
Requirement of CPP from COO or reference countries
The regulatory agencies in the SE Asia countries, listed in Table 3, have been
organized differently and some changes have taken place in the recent years.
The most significant change in the system was seen in Singapore. In 2001, the
Singapore agency was reorganized into a statutory board known as the Health
Sciences Authority that run in a corporative fashion. The agency has established
two centers to deal with drug registration; the Centre of Pharmaceutical
Administration (CPA) is the licensing body that performs administrative work
related to drug registration while the Centre of Drug Evaluation (CDE) to perform
scientific and medical evaluations of new drug applications. The CDE has
established for the first time in-house capability for scientific and medical reviews
of submissions and provide regulatory consultations to the industry. However
partly due to the small number of staff available at the CDE, the center still have
to rely heavily on external reviewers, many of them academic pharmaceutical
and medical scientists from the local university. Many other regulatory agencies
in SE Asia have similar constraint in in-house resources dealing with new drug
applications, the reviewing process involves external experts in their countries at
some points.
4. Ellick Wong/ Regulatory environment and clinical trials in SEA - 4 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Table 3. Regulatory Agencies in S.E. Asia
Indonesia : National Agency of Drug & Food Control
Malaysia :Drug Control Authority, NCE Unit
Philippines :BFAD, DoH
Thailand : ThaiFDA, Drug Control Div.
Singapore : Health Sciences Authority (HSA)
Centre for Pharmaceutical Admin. (CPA)
Centre for Drug Evaluation (CDE)
Dug Registration in SE Asia
In the region, drug registration processes vary considerably among the countries
with different sets of requirements for new drug approvals. From the past
experience, the approval timelines in the countries vary from 6 to 24 months.
The author has analyzed available in-house data on 6 new drugs recently
registered in the 5 ASEAN countries and the approval timelines are shown in
Figure 1. The data also allowed estimation of the ranges of registration timelines
in the countries to be made: Singapore and Thailand, 6-12 months, Indonesia
and the Philippines 12 –18 months and Malaysia may take up to 2 years.
8.3
23.9
8.8
16.6
7.6
7.7
16.4
4.1
11.9
4.1
9.2
37.3
4.9
26.8
4.3
19.8
9.6
9.2
22.2
9.9
20.2
15.8
5.7
9.5
7.2
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Singapore
M
alaysia
Thailand
Indonesia
Philippines
No. of Months
Product A Product B Product C Product D Product E Product F
Figure 1. NCE Approval Time
7.5
21.4
9.1
12.6
15.3
5. Ellick Wong/ Regulatory environment and clinical trials in SEA - 5 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Registration Requirements
Table 4 shows the requirements of various regulatory and administrative
documents for new drug registration in the 5 countries. All countries require CPP
and GMP certificates. All countries prefer to have CPP from COO, however for
Singapore, Indonesia and Thailand, CPP from selected countries other than
COO could be used. With the exception of Malaysia, all countries require CPP at
the point of filing. Table 5 shows more details on the CPP requirements and
timing of submission.
Indonesia authority would require additional Free Sales Certificate issued by an
advanced country. For Philippines and Thailand, the CPP and GMP certificates
would need to be legalized. Most countries also demand submission of copies
of manufacturing licenses of the manufacturers and packagers for products to be
registered. Because of cultural and religious reasons, Indonesia, Malaysia and
Philippines authorities require information on sources of all ingredients of animal
origin. The Indonesian authority will not approve products containing any
ingredient of porcine source.
Indonesia
Malaysia
Philippines
Singapore
Thailand
Remarks
Regulatory / Administrative
Documents
CPP (COO) Y Y Y Y Y MALAYSIA: CPP at Stage 3
Y track II
GMP Certificates (Manufacturer &
Packager)
Y Y Y Y Y
Notarized & Legalized of above? Y Y
Y Y Y
Patent Information Y Y Y
Y
Y Y Y Y
Y Y Y INDONESIA : porcine sources
not acceptable.
For ingredient of animal origin:
Declarations specifying the origin (animal
species)
Manufacturer's Registration
Table 4. REGISTRATION REQUIREMENTS
Additional FSC (2)
Manufacturing license (Manufacturer &
Packager)
Info of manufacturers of ingredients
.
6. Ellick Wong/ Regulatory environment and clinical trials in SEA - 6 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Table 5. CPP REQUIREMENTS
SubmissionCOO is required for approval. Export certificate can be
used in place of a CPP from COO for submission, but
CPP from COO is required for approval.
PHILIPPINES
SubmissionCOO – for Track I and Track III
Track II – Assessment Reports + 2 CPPs (EMEA &/or
countries with GES) or Assessment Reports + 3 CPPs
(countries with GES)
INDONESIA
SubmissionCOOTHAILAND
Stage 3COO (Manufacturer or final packager/ product releaser)MALAYSIA
SubmissionCOO or from the recognized countries (with CPA’s
permission)
SINGAPORE
Required atCPP RequirementsCountry
Table 6 shows the other requirements for new drug registration. The common
files are formulation, manufacturing method, method of analysis and
specifications, cert of analysis, and stability report. The Philippines authority
requires additional documents such as in-process control, validation documents
and plant descriptions. Most countries require samples of product, samples for
testing and working standards. All countries also would need to have proposal
for labeling and pack insert. Documents on pre-clinical, pharmacology,
toxicology, clinical pharmacology and clinical studies are standard requirements.
The Malaysian and Thai authorities require additionally 3 published studies; this
requirement has often presented difficulties for companies to fulfill and delay the
registration.
7. Ellick Wong/ Regulatory environment and clinical trials in SEA - 7 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Indonesia
Malaysia
Philippines
Singapore
Thailand
Remarks
Basic CMC Documents
In Process Control Y Y Y
Formulation Y Y Y Y Y
Manufacturing Method Y Y Y Y Y
Method of Analysis & Specifications Y Y Y Y Y
Validation Documents
Y Y Y Singapore - Protocol, Reports
and Summary of Results.
Plant Facility Description Y Y Y
Y Y Y
Y Y Y Y Y Philippines - numerical /
descriptive results.
Y Y Y Y Y
Registration Samples
3 5 2 2
Samples for Analytical Testing with CoA Y Y Y Y
Y Y Y
Packaging Materials
Y Y Y Y Y
3 5 5 2 5
Y Y Y Y Y
Pre-Clinical & Clinical Documents
Y Y Y Y Y
Pharmacology & Toxicology Y Y Y Y Y
PD / PK Y Y Y Y Y
Y Y Y Y
Clinical Documents Y Y Y Y Y
Published Clinical Papers 3 3
Visual Samples (Commercial Packs) with
Original CoA
Samples of Working standards
Pre -Clinical Documents
Bioavailability study report
Table 6. REGISTRATION REQUIREMENTS
Proposal for labeling (artwork; carton,
labels, blisters, package insert)
No. of sets required
CoA for each excipients
CoA of Final Product
Stability Report
Pack Insert
Regulatory Review and Approval Process
The review processes vary from country to country in the region. In Indonesia, a
pre-registration consultation should take place before formal submission of files.
The procedures are defined by three tracks. Track I is for orphan drugs or drugs
for treating life-threatening diseases. Track II and III are for products carrying
different approval status. The agency sets target review timelines for Track I
at100 days, Track II at 150 days, and Track III at 300 days. For Track II products,
assessment reports are required on top of a CPP, although CPP from non-COO
is acceptable. The fee for registration is Indonesian Rupiah 20 million (about
US$2,000).
In Malaysia, the drug registration process is in 3 stages with different
documentations submitted at each stage. CPP from COO is submitted only at
8. Ellick Wong/ Regulatory environment and clinical trials in SEA - 8 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Stage 3. This facilitates early new product filing in Malaysia while the product is
under review by health authorities elsewhere, in COO and other advanced
countries. The registration fee is RM1000 (about US$300). The target review
timeline ranges 38 to 66 weeks.
In Thailand, after filing, the company can choose to make a formal presentation
to the agencies staff and medical reviewers on data submitted. After approval,
most new drugs are subjected to post-marketing surveillance (PMS) for several
years and hence the authority would demand PMS study protocol to be
submitted before product approval is granted. The registration fee is Thai Baht
2,000 (about US$50). The target review timeline is 7 months.
In the Philippines, the agency may request the company to perform local
registration trial if there is no proof of the product’s clinical use in more than
5,000 patients in the COO; even the product is approved in the COO. The fee for
product registration is around PhP 20,000 (about 400 USD) and the target review
timeline is 12 to 18 months.
In Singapore, since the establishment of the CDE, the submission of new drug
application via the so-called ‘CDE route’ could be done prior to any approval of
the product elsewhere and hence one can file for new drug registration in
Singapore simultaneously as the NDA is filed in the COO or in other advanced
countries. The fee is in the region of S$8,000 (about US$4,500) for a file of
10,000 pages. More detailed fee structure for submission could be found in CDE
web-site
(http://www.hsa.gov.sg/hsa/CDE/CDE_service_directory_feesschedulefornda.ht
m). Target review timeline is 30 weeks.
In Singapore, one can also file product registration following a conventional route
of registration via the CPA office. As this route of filing demands the submission
of CPP, this is only possible for products previously approved in COO or in other
advanced countries. The registration fee is S$545 (about US$280) and the
target review timeline is 17 weeks. There is a fast track review route but the
authority requires assessment reports on the product from two advanced
countries.
ASEAN Regulatory Harmonization Initiative
A recent Centre of Medicine Research International survey (1) showed that most
international companies would prefer to submit registration files simultaneously in
Asia when the NDA is submitted to the COO or other developed countries.
However due to various reasons, not many companies can achieve this goal and
certainly not with all their products. It is well recognized that there are still many
regulatory barriers hindering simultaneous submission in SE Asia and the
diversity in requirements is one of the most important. In view of this, the ASEAN
9. Ellick Wong/ Regulatory environment and clinical trials in SEA - 9 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
countries have started a harmonization initiative in 1999. The initiative, known as
the ASEAN Consultative Committee for Standards and Quality – Pharmaceutical
Product Working Group (ASEAN CCCSQ-PPWG), aimed at establishing
common technical requirements and to develop quality guidelines for product
registrations. When these documents are ready and be implemented in 2003 -
2004, the registration timelines in ASEAN will be significantly aligned.
While waiting for the ultimate harmonization to become a reality, the Singapore
agency HSA has been progressive in making international cooperation. HAS has
recently signed pact with the health authority of Australia, TGA. The cooperation
is aiming at a better sharing of experiences and this will bring an improved
reviewing process to Singapore.
Clinical Trials in SE Asia
Asia is increasingly being recognized as an important base for R&D. Many multi-
national research-based pharmaceutical companies are beginning to see the
potential of Asia in contributing to drug development. Several companies and
CROs have established their trial monitoring organizations and built facilities in
Asia to perform trials to international standards and meeting regulatory
requirements. The large patient pool available for trials in Asia has potential for
faster patient recruitment, and hence trials involving Asia medical centers may
contribute to shortening the development time of new drugs. A recent review has
discussed the challenges and benefits of conducting drug development clinical
trials in SE Asia (2).
Many companies have already successfully conducted many drug development
global studies in SE Asia. With close clinical trial monitoring and professional
project management, many medical centers particularly those located in major
cities could perform high quality GCP studies and they often can compete very
favorably in terms of patient recruitment and costs with other centers in the
Europe, USA or Latin America.
For the past many years, although SE Asian countries had demonstrated their
capabilities in performing clinical trials, there were still many issues which
discouraged companies from bringing in Phase II and III studies to the region.
One of the issues was the long clinical trial approval process. It sometimes took
longer than 6 months for an approval to be granted in some countries and hence
limits their participation. With the joint efforts of industry, hospital and regulatory
authorities, there has been a steadily improvement in shortening the timelines
lately. In some countries nowadays, IRB and regulatory submissions could be
done simultaneously and this has significantly improved the overall timeline for
new trial start-up. In general, the approval timeline now is 3 to 4 months in SE
Asia and for most trials it is acceptable for them to join. Table 7 shows the
average timelines for clinical trial approvals in the 5 ASEAN countries.
10. Ellick Wong/ Regulatory environment and clinical trials in SEA - 10 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Table 7. Clinical Trial Approval Timelines in SE Asia
6Y1659Philippines
3N1469Thailand
3
4
12
No of
studies
N14105Malaysia
Y13117Indonesia
N1138Singapore
Parallel
(Y/N)
Approval
period
(weeks)
Regulatory
Approval
(median weeks)
IRB
Approval
(Median weeks)
In many of the SE Asian countries, the governments have identified the
biomedical/life sciences industry as a key segment for future economic growth.
Among them, the Singapore government has been particularly active in this area.
They offer support and financial incentives to pharmaceutical and biotechnology
companies to build research facilities and train manpower resources to develop
R&D. Figure 2 shows that the effort of the Singapore government in promoting
clinical trials in the past few years has really paid off. The number of clinical trials
reflected by the numbers of Clinical Trial Certificates applications to the health
authority has increased exponentially over the past years. Also it is worth to note
that majority of the trials conducted in Singapore these days are in Phase II and
III. In Singapore, the number of Phase I trials has also significantly increased
after two Phase I laboratories were established by multi-national pharmaceutical
companies recently.
11. Ellick Wong/ Regulatory environment and clinical trials in SEA - 11 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
Total no. of Clinical Trial Applications
0
20
40
60
80
100
120
140
160
180
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
Year
No.ofApplications Figure 2. Number of Clinical Trial Certificate
Applications in Singapore
Drug Trials Growing in AsiaDrug Trials Growing in Asia
SingaporeSingapore
Singapore – Clinical Trials (2001)SingaporeSingapore –– Clinical Trials (2001)Clinical Trials (2001)
Phase I Phase II Phase III Phase IV
30% (50)
12% (19)17% (28)
41% (68)
Phase I
Phase II
Phase IV
Phase III
12. Ellick Wong/ Regulatory environment and clinical trials in SEA - 12 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
In the other ASEAN countries, the clinical trial activities have just begun. Table 8
shows the number of clinical trial approvals issued by the authorities in Malaysia,
Philippines and Indonesia in year 2000 and 2001. Although the numbers of trials
in Phase III are still rather low in these countries, there is a trend that the
numbers are increasing. It is foreseeable that SE Asia countries’ contribution to
global drug development will grow from strength to strength in the near future.
Figure 8 . Clinical Trials in SE AsiaFigure 8 . Clinical Trials in SE AsiaFigure 8 . Clinical Trials in SE Asia
Philippines
85 (2000) 100 (2001)
Indonesia
(mainly phase IV)
Phase IV
Phase III
106 (2000) 60 (2001)
23 (2000) 42 (2001)
29 (2000) 53 (2001)
Phase IV
Phase III
8 (2000) 9 (2001)
Malaysia
Data provided by the health authorities in the respective countries
Global Drug Development and Simultaneous Drug Registration
The Centre of Medicine Research International conducted recently reported a
survey (3) they did with multinational pharmaceutical companies on their
involvement of Asian countries (ex-Japan) in conducting their drug development
trials. Based on the responses from 13 companies, 8 routinely conducted clinical
trials in Asian countries; all 8 companies used local trial data for regulatory
submissions. Three companies had conducted pivotal studies in Asia, and 2 of
them had included Asian data in their ICH submissions.
The results from the survey were indicative of some multinational research-based
pharmaceutical companies’ strategy in including Asia in their globalised drug
development program. Increase in the participation in global drug development
programs by Asian medical centers will contribute to shorten development time
and to achieve simultaneous drug registration, and thereby to reach the goal
shared by all in drug industry and regulatory agencies: ensuring quicker access
13. Ellick Wong/ Regulatory environment and clinical trials in SEA - 13 –
Ellick Wong--Regulatory Enviroment and Clinical Trials in South East Asia
to new and innovative medicines for all patients and to meet their medical needs
wherever they are.
References
1. Center of Medicine Research International, CMR Report, June 2001 (web-site:
www.cmr.org)
2. CF Fenn, E Wong, D Zambrano. The contemporary situation for the conduct
of clinical trials in Asia, Int. J. Pharm. Medicine 2001, 15: 169-173
3. Center of Medicine Research International, CMR R&D Briefing No 37.
December 2002 (web-site: www.cmr.org)