Online Application
•Download as PPT, PDF•
1 like•7,498 views
This document outlines guidelines for filing applications using an Integrated Application Form adopted by the Philippines' Food and Drug Administration (FDA) to streamline the application process. The form was created to comply with laws mandating improved efficiency and accountability in government services. It consolidates requirements for various FDA authorizations like licenses and permits onto a single electronic form. Applicants must submit documentary requirements digitally, pay fees, and provide hard copies of certain documents to complete the application process based on a scheduled intake procedure.
Report
Share
Report
Share
Recommended
Product recall overview
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
AO 56 revised presentation
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
Checklist of Requirements
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
Overview Drug, Alternative Medicines, Medical Devices Registration in Pakistan
Overview of DRAP requirement regarding Drug Manufacturing And License Fee,Drug Registration and Drug Registration Fee , Drug Pricing, Enlistment and Enlistment Fee, Medical Devices and Medical Devices Fee
handling of pharmaceutical product recall
The document discusses pharmaceutical product recalls. It begins by defining a recall as a firm's removal or correction of a marketed product deemed in violation of laws by the FDA. Reasons for recalls include super or sub-potent formulations, particulate contamination, poor manufacturing, mislabeling, incorrect contents, and health hazards. Recalls are classified by the FDA and EMA into three classes depending on health risk level. The recall process, strategy, effectiveness checks, termination, and regulatory requirements are also outlined. Tips are provided for what consumers should do if the drug they are taking is recalled.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Software Evaluation Checklist
This rubric evaluates software based on 9 criteria: content, design, functionality, instructional design, interactivity, assessment, usability, technology, and accessibility. Software receives higher scores for providing accurate, reliable content aligned to standards. It also scores well for intuitive navigation, multimedia enhancements, feedback and support for learners, and easy integration into classroom activities. The rubric assesses whether the software engages students and allows teachers to track progress.
Introduction to pharmaceutical regulatory agencies
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public.
They work to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are Governmental or Non-governmental play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
Recommended
Product recall overview
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
AO 56 revised presentation
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
Checklist of Requirements
This document outlines the requirements for obtaining and renewing a license to operate (LTO) for a drug establishment. It lists 11 documents required for an initial inspection, including documents proving ownership or lease of the establishment, permits, pharmacist qualifications, and standard operating procedures. An additional 13 documents are required for importers, wholesalers, or exporters. Reference materials and standard operating procedures must be presented at inspection. Reissuance of an LTO requires surrender of the original LTO, a picture of the establishment, and proof of renewal fees.
Overview Drug, Alternative Medicines, Medical Devices Registration in Pakistan
Overview of DRAP requirement regarding Drug Manufacturing And License Fee,Drug Registration and Drug Registration Fee , Drug Pricing, Enlistment and Enlistment Fee, Medical Devices and Medical Devices Fee
handling of pharmaceutical product recall
The document discusses pharmaceutical product recalls. It begins by defining a recall as a firm's removal or correction of a marketed product deemed in violation of laws by the FDA. Reasons for recalls include super or sub-potent formulations, particulate contamination, poor manufacturing, mislabeling, incorrect contents, and health hazards. Recalls are classified by the FDA and EMA into three classes depending on health risk level. The recall process, strategy, effectiveness checks, termination, and regulatory requirements are also outlined. Tips are provided for what consumers should do if the drug they are taking is recalled.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTS
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
Software Evaluation Checklist
This rubric evaluates software based on 9 criteria: content, design, functionality, instructional design, interactivity, assessment, usability, technology, and accessibility. Software receives higher scores for providing accurate, reliable content aligned to standards. It also scores well for intuitive navigation, multimedia enhancements, feedback and support for learners, and easy integration into classroom activities. The rubric assesses whether the software engages students and allows teachers to track progress.
Introduction to pharmaceutical regulatory agencies
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public.
They work to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are Governmental or Non-governmental play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
ASEAN COUNTRIES.pptx
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
FDA Warning Letter
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Complaints and recalls
This document discusses complaints and recalls procedures for pharmaceutical products. It outlines the objectives of complaint handling, defines complaint procedures and classifications of defects. Critical defects pose life-threatening risks and require immediate action. Major defects present some risk to patients and require batch recall within days. Other defects have minimal risks. Recall procedures include designating an authorized person to manage the recall according to a standard operating procedure and maintaining distribution records to effectively recall affected products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Marketing Authorization Procedure in European Union
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
Presentation on EU Regulatory & Quality System.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
GOOD AUTOMATED LABORATORY PRACTICE
Good regulatory practice regulation, third edition, revised and expand, edit by GERALDJ.WHARTENBY, PAULL.ROBINSON, and SANDYWEINBERG, Muhlenberg College Allentown, Pennsylvania, U.S.A., Copyright © 2003 Marcel Dekker, Inc. 154-161.
https://en.wikipedia.org/wiki/Title_21_CFR_Part_11. Pg.1,2&3, 28/9/2019
https://www.fda.gov/, title 21- food and drugs, chap-1 food and drug administration department of health and human services subchapter A , part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, source 62 FR 13464, mar.20,1997,.
http://www.techstreet.com/direct/21CFRPart11_sample.pdf EVIDENCE PRODUCT CHECKLIST For the FDA Document
“FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule”
Site master file
site master file is a document which explains about a site manufacturing, QA, QC and all the department in the industry
overview of Japan pharmaceutical regulatory authority - PMDA
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Complaints , quality defects & recalls - New EMA Requirements
Complaints , quality defects & recalls - New EMA RequirementsGMP EDUCATION : Not for Profit Organization
The European Commission has published the final EU Guidelines for Complaints, Quality Defects and Product Recalls.
Significant changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. This presentation captures the new requirements.regulatory requirement for bioequivalence
The document discusses regulatory requirements for bioequivalence studies from the FDA and WHO perspectives. It defines key terms like bioavailability, bioequivalence, reference product and generic products. It also outlines FDA guidelines on bioequivalence documentation for INDs, NDAs and ANDAs. Test procedures for establishing bioequivalence include pharmacokinetic, pharmacodynamic and clinical studies according to FDA regulations. Pharmacokinetic studies are emphasized for directly measuring drug absorption. Study design considerations like single vs multiple dose studies are also covered.
Line clearance ppt
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
Quality review
The document discusses quality review, which involves reviewing all specifications and documentation at check points to ensure they are met. It outlines specific procedures to check, such as foreign matter, correct ingredients and amounts, separation of lots, storage conditions, cleaning, personnel readiness, and meeting specifications. Quality review also involves reviewing material, production, in-process, laboratory, and stability testing records using the 4M concept of material, method, machinery, and men.
Fda regulations for pharmaceutical packaging
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
Who Guidance on Quality Risk Management
This document summarizes guidelines published by the World Health Organization (WHO) on Quality Risk Management (QRM) for pharmaceuticals. The WHO guidelines were published in 2013 and provide an updated, risk-based approach for regulators and manufacturers to ensure quality, safety and efficacy of medicines. Key points include:
- QRM is a systematic process to assess, control, communicate and review risks to product quality throughout the product lifecycle. It can be applied both proactively and retrospectively.
- For regulators, QRM allows prioritization of inspection resources based on product risks. For manufacturers, it encourages innovation through science-based quality decisions.
- The level of QRM should be commensurate with risk
Recall procedures
The document outlines FDA procedures and responsibilities for product recalls. It discusses how recalls are initiated and classified into three classes based on health hazard. FDA monitors recall effectiveness and will terminate a recall when corrective actions are complete. Recalling firms are responsible for determining the scope and depth of recalls, communicating with FDA and customers, and issuing any necessary press releases. The document provides an overview of drug recalls that occurred in 2013.
Vendor selection
Vendor selection and certification is important for pharmaceutical companies to ensure quality control and regulatory compliance. It involves categorizing vendors based on risk level and monitoring them accordingly. The key steps are:
1) Evaluating vendors based on criteria like quality, delivery, facilities, financials, and compliance history.
2) Classifying them into categories from 1 to 4 based on risk, with category 1 needing minimal oversight and category 4 requiring intense monitoring.
3) Qualifying vendors through assessing processes, specifications, changes, and customer inspections to ensure quality standards are met.
4) Conducting periodic audits and follow-up visits to ensure continued compliance. This helps build confidence and trust in the vendor-customer relationship.
Regulation of Dietary Supplements
Presentation to the San Diego Regulatory Affairs Network (SDRAN) RAC Review course; August 2011; covering:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
Product life cycle management
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
Regulatory requirements for drug approval in Saudi Arabia
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Investment
GOS Secured Investment
• Innovative investment with low risk and high returns.
• We provide legal agreements to secure investor’s capital.
• Our investment scheme can help the economy’s unemployed individuals around the globe.
• Proven system that the investment capital will gain high returns in a period of time.
• Hassle free investment with minimal requirements.
• Provides regular income that anyone can invest.
• Income can be directly withdrawn through an ATM machine with our cash card.
• 6 months money back guarantee.
• Lifetime monthly income from investment that is transferrable.
• Flexible investment according to your financial circumstances.
• Transparency and weekly reports through our main website.
• Leveraging your time and money to achieve ultimate freedom.
• 1 time investment without revolving capital.
http://gos-investments.com/pricing/gos-investment-packages/
Administrative Order No. 2014-0034
This document outlines administrative order no. 2014-0034 from the Philippines Department of Health Food and Drug Administration. It establishes rules for licensing drug establishments to ensure compliance with Good Manufacturing Practice, Good Distribution Practice, and other standards. It prescribes the use of electronic submissions and signatures. The order classifies different types of drug establishments and outlines requirements for licensing, variations, renewals, and inspections. It aims to align drug establishment operations with laws and international regulatory standards to ensure safety, efficacy and quality of drugs.
More Related Content
What's hot
ASEAN COUNTRIES.pptx
The document provides an overview of medical device regulations in ASEAN countries. It discusses the ASEAN Medical Device Directive (AMDD), which provides harmonized regulations across ASEAN nations. It outlines the medical device classification system and regulatory registration procedure, including requirements for quality systems and clinical evaluation/investigation. Key aspects covered are the ASEAN Common Submission Dossier Template for product registration and ISO 13485 standards for quality management systems.
FDA Warning Letter
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
Complaints and recalls
This document discusses complaints and recalls procedures for pharmaceutical products. It outlines the objectives of complaint handling, defines complaint procedures and classifications of defects. Critical defects pose life-threatening risks and require immediate action. Major defects present some risk to patients and require batch recall within days. Other defects have minimal risks. Recall procedures include designating an authorized person to manage the recall according to a standard operating procedure and maintaining distribution records to effectively recall affected products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Marketing Authorization Procedure in European Union
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
Presentation on EU Regulatory & Quality System.
This presentation provides information about the regulatory system for pharmaceutical manufacturers and GMP inspections in the European Union. It is compiled by Drug Regulations, a nonprofit organization that provides online resources for pharmaceutical professionals. The presentation explains that the EU has a harmonized system where the same rules and procedures apply in all 28 member states, which is overseen by the European Medicines Agency and national competent authorities. Manufacturers supplying products to the EU must comply with Good Manufacturing Practice standards and are subject to regular inspections.
GOOD AUTOMATED LABORATORY PRACTICE
Good regulatory practice regulation, third edition, revised and expand, edit by GERALDJ.WHARTENBY, PAULL.ROBINSON, and SANDYWEINBERG, Muhlenberg College Allentown, Pennsylvania, U.S.A., Copyright © 2003 Marcel Dekker, Inc. 154-161.
https://en.wikipedia.org/wiki/Title_21_CFR_Part_11. Pg.1,2&3, 28/9/2019
https://www.fda.gov/, title 21- food and drugs, chap-1 food and drug administration department of health and human services subchapter A , part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, source 62 FR 13464, mar.20,1997,.
http://www.techstreet.com/direct/21CFRPart11_sample.pdf EVIDENCE PRODUCT CHECKLIST For the FDA Document
“FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule”
Site master file
site master file is a document which explains about a site manufacturing, QA, QC and all the department in the industry
overview of Japan pharmaceutical regulatory authority - PMDA
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Complaints , quality defects & recalls - New EMA Requirements
Complaints , quality defects & recalls - New EMA RequirementsGMP EDUCATION : Not for Profit Organization
The European Commission has published the final EU Guidelines for Complaints, Quality Defects and Product Recalls.
Significant changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. This presentation captures the new requirements.regulatory requirement for bioequivalence
The document discusses regulatory requirements for bioequivalence studies from the FDA and WHO perspectives. It defines key terms like bioavailability, bioequivalence, reference product and generic products. It also outlines FDA guidelines on bioequivalence documentation for INDs, NDAs and ANDAs. Test procedures for establishing bioequivalence include pharmacokinetic, pharmacodynamic and clinical studies according to FDA regulations. Pharmacokinetic studies are emphasized for directly measuring drug absorption. Study design considerations like single vs multiple dose studies are also covered.
Line clearance ppt
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
Quality review
The document discusses quality review, which involves reviewing all specifications and documentation at check points to ensure they are met. It outlines specific procedures to check, such as foreign matter, correct ingredients and amounts, separation of lots, storage conditions, cleaning, personnel readiness, and meeting specifications. Quality review also involves reviewing material, production, in-process, laboratory, and stability testing records using the 4M concept of material, method, machinery, and men.
Fda regulations for pharmaceutical packaging
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
Who Guidance on Quality Risk Management
This document summarizes guidelines published by the World Health Organization (WHO) on Quality Risk Management (QRM) for pharmaceuticals. The WHO guidelines were published in 2013 and provide an updated, risk-based approach for regulators and manufacturers to ensure quality, safety and efficacy of medicines. Key points include:
- QRM is a systematic process to assess, control, communicate and review risks to product quality throughout the product lifecycle. It can be applied both proactively and retrospectively.
- For regulators, QRM allows prioritization of inspection resources based on product risks. For manufacturers, it encourages innovation through science-based quality decisions.
- The level of QRM should be commensurate with risk
Recall procedures
The document outlines FDA procedures and responsibilities for product recalls. It discusses how recalls are initiated and classified into three classes based on health hazard. FDA monitors recall effectiveness and will terminate a recall when corrective actions are complete. Recalling firms are responsible for determining the scope and depth of recalls, communicating with FDA and customers, and issuing any necessary press releases. The document provides an overview of drug recalls that occurred in 2013.
Vendor selection
Vendor selection and certification is important for pharmaceutical companies to ensure quality control and regulatory compliance. It involves categorizing vendors based on risk level and monitoring them accordingly. The key steps are:
1) Evaluating vendors based on criteria like quality, delivery, facilities, financials, and compliance history.
2) Classifying them into categories from 1 to 4 based on risk, with category 1 needing minimal oversight and category 4 requiring intense monitoring.
3) Qualifying vendors through assessing processes, specifications, changes, and customer inspections to ensure quality standards are met.
4) Conducting periodic audits and follow-up visits to ensure continued compliance. This helps build confidence and trust in the vendor-customer relationship.
Regulation of Dietary Supplements
Presentation to the San Diego Regulatory Affairs Network (SDRAN) RAC Review course; August 2011; covering:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
Product life cycle management
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
Regulatory requirements for drug approval in Saudi Arabia
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
What's hot (20)
Comparison of Clinical Trial Application requirement of India, USA and Europe.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
Marketing Authorization Procedure in European Union
Marketing Authorization Procedure in European Union
overview of Japan pharmaceutical regulatory authority - PMDA
overview of Japan pharmaceutical regulatory authority - PMDA
Complaints , quality defects & recalls - New EMA Requirements
Complaints , quality defects & recalls - New EMA Requirements
Regulatory requirements for drug approval in Saudi Arabia
Regulatory requirements for drug approval in Saudi Arabia
Viewers also liked
Investment
GOS Secured Investment
• Innovative investment with low risk and high returns.
• We provide legal agreements to secure investor’s capital.
• Our investment scheme can help the economy’s unemployed individuals around the globe.
• Proven system that the investment capital will gain high returns in a period of time.
• Hassle free investment with minimal requirements.
• Provides regular income that anyone can invest.
• Income can be directly withdrawn through an ATM machine with our cash card.
• 6 months money back guarantee.
• Lifetime monthly income from investment that is transferrable.
• Flexible investment according to your financial circumstances.
• Transparency and weekly reports through our main website.
• Leveraging your time and money to achieve ultimate freedom.
• 1 time investment without revolving capital.
http://gos-investments.com/pricing/gos-investment-packages/
Administrative Order No. 2014-0034
This document outlines administrative order no. 2014-0034 from the Philippines Department of Health Food and Drug Administration. It establishes rules for licensing drug establishments to ensure compliance with Good Manufacturing Practice, Good Distribution Practice, and other standards. It prescribes the use of electronic submissions and signatures. The order classifies different types of drug establishments and outlines requirements for licensing, variations, renewals, and inspections. It aims to align drug establishment operations with laws and international regulatory standards to ensure safety, efficacy and quality of drugs.
Good distribution practices for API's
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Good Storage Practice
This document discusses good practices for storing pharmaceutical products in pharmacies. It emphasizes that medicines must be stored properly under the correct conditions to ensure their potency does not expire before the listed expiry date. Every pharmacy needs systems for secure, clean storage with accurate record keeping and stock rotation. Key requirements include preventing access from moisture, light, heat, pests and proper refrigeration. Standard operating procedures should be established in writing for all storage activities.
Neuro-linguistic programming
Nevrolingvistično programiranje (NLP) je skupek metod, ki omogočajo spreminjanje odločitvenih in vedenjskih vzorcev ljudi. Teorijo NLP sta v 70-ih razvila Richard Bandler in John Grinder, kmalu zatem pa je NLP postal svetovna uspešnica na seminarjih za izobraževanje prodajalcev in t.i. srednjega managementa. Na predavanju smo si ogledali izvirno NLP metodologijo ter jo pojasnili na nekaj konkretnih primerih iz prakse, poglobili pa smo se tudi v najsodobnejša odkritja nevroloških znanosti in raziskali njihove implikacije v poslovnem in družabnem kontekstu delovanja človeka. Predava Matevž Leskovšek, raziskovalec v Laboratoriju za Biokibernetiko Univerze v Ljubljani, projektni vodja v skupini Labena Razvoj in Raziskave ter aktivni član Poslovnega Kluba Byron - društva za izmenjavo in promocijo dobrih poslovnih praks.
Edpms v2.0 u pdates 2012 for ao56
This document provides information about the Electronic Drug Price Monitoring System (e-EDPMS) implemented by the Department of Health in the Philippines. It discusses the objectives of e-EDPMS to improve data collection on drug prices and inventories in support of relevant laws. The document outlines the system scope and procedures for facilities to register personnel, upload electronic data on a monthly basis, and defines key terms like purchase and selling prices. It provides links to download the standalone software installer and user manual to allow offline data entry and file generation for uploading.
EDPMS Overview
This document provides information and instructions for using the Electronic Drug Price Monitoring System (EDPMS). It summarizes the laws requiring drug price monitoring, outlines the EDPMS process for uploading price data, and details the forms and support available. Pharmaceutical suppliers are mandated to regularly upload price and inventory data to the EDPMS website to participate in government drug biddings and avoid administrative sanctions for noncompliance.
Good Dispensing Practice
The document outlines the process and factors involved in good dispensing practice. It discusses receiving and validating prescriptions, interpreting prescriptions, preparing and labeling items, checking preparations, recording dispensed items, and issuing medicines to patients with instructions. Key factors that affect good dispensing include qualified staff, clean premises and equipment, and following proper procedures for each step of the dispensing cycle. The overall goal is to ensure patients receive the correct medication as prescribed.
Viewers also liked (8)
Similar to Online Application
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...
The document discusses regulatory requirements for drug registration and post-approval requirements in Saudi Arabia. It provides information on the Gulf Cooperation Council agreement between six Middle Eastern countries to harmonize regulatory standards. The Saudi Food and Drug Authority regulates drugs in Saudi Arabia, requiring electronic submissions through its eCTD format. Drugs must undergo assessment of quality, safety and efficacy to receive approval and be licensed for marketing. Post-approval, variations and renewals are regulated, and fees apply to the different application and registration types.
Copp - CERTIFICATE OF PHARMACEUTICAL PRODUCT
The document discusses the Certificate of Pharmaceutical Product (CoPP), which is issued by regulatory authorities to help importing countries assess the quality of pharmaceutical products. It outlines the importance of the CoPP for product registration in other countries. The summary also describes the application process for obtaining a CoPP in India, including requirements for documentation, inspections, and the format of the certificate.
Regulation Governing Clinical Trials In India,USA and Europe.
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Premarket Notification 510(k) for Biologics [Autosaved].pptx
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
COPP.pptx
The document provides information about Certificates of Pharmaceutical Product (COPP):
- A COPP is issued by national health authorities in the exporting country upon request from authorities or suppliers in the importing country. It certifies that a pharmaceutical product complies with Good Manufacturing Practices and is approved for sale in the exporting country.
- The COPP allows registration and marketing of the product in the importing country and is necessary for registration renewal. It helps authorities in importing countries assess product quality for import/registration.
- The application process involves submitting documents like manufacturing licenses and quality manuals. Facilities undergo inspection to verify compliance with WHO GMP guidelines. Certifications are issued for approved products and may expire after 24
Canadian Medical Devices Conformity Assessment System(CMDCAS) - Training mate...
This document provides an overview and agenda for a training on the Canadian Medical Devices Conformity Assessment System (CMDCAS). The training will cover ISO 13485 quality management system audits performed by Health Canada recognized registrars, certificate requirements, and audit report content. It will also review specific CMDCAS requirements, the transition to ISO 13485:2016 and the Medical Device Single Audit Program. The objective is to help participants understand how to incorporate CMDCAS into their quality management system documentation and prepare for an audit.
Pharmaceutical Dossier submission
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines dossiers as collections of documents providing detailed information about a subject. Registration dossiers contain all administrative, quality, nonclinical and clinical data required for approval of a pharmaceutical product in a given country. Common dossier formats used in the industry include CTD, ACTD and eCTD formats, which organize information into modules. Proper planning, compilation and review are important for effective dossier management and regulatory submission.
Good Regulatory Practice.pptx
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Overview of Japanese Foreign Manufacturers Accreditation
This document discusses the process for foreign manufacturers to obtain accreditation from the Japanese Ministry of Health, Labour and Welfare to export medical devices to Japan. It outlines the requirements, application process, and fees for initial accreditation, changes to an existing accreditation, renewal of accreditation, and notifications of changes. The accreditation process involves submitting application documents to both the Ministry and the Pharmaceutical and Medical Devices Agency, who reviews facilities and processes to ensure compliance with Japanese regulations.
Presentation: Update from the Medical Devices Branch
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
Guidelines for import and manufacture of medical devices
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
Dossier preparation and submission
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines a dossier as a collection of documents on a subject used to propose approval of a new drug. Dossiers contain administrative, quality, nonclinical, and clinical data. Common dossier formats include CTD, ACTD, and eCTD, which are used globally and in various regions. Careful compilation, review, and planning is required to ensure dossiers meet all regulatory requirements for submission.
Regulation of herbal drugs in india
The document discusses the regulatory status of herbal drugs in India. It outlines that herbal drugs are regulated under the Drug and Cosmetic Act of 1940 and Rules of 1945. The Department of AYUSH is the regulatory authority that requires manufacturing and marketing licenses. It also discusses definitions, licensing procedures, good manufacturing practices, labeling requirements, and guidelines set by AYUSH.
Medical Device Administration In China
This document discusses medical device administration in China. It outlines the competent authorities that regulate medical devices, including the SFDA and Center for Medical Device Evaluation. It also describes the administration activities like registration, production, sales, and post-marketing surveillance. The document then summarizes the laws and regulations regarding medical devices and classifies medical devices into three categories based on risk. It provides details on administration of production, sales, and registration of medical devices in China.
Canada medical device approval chart - EMERGO
1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.
Medical device regulations
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
13 Medical Device Single Audit Program (MDSAP) Working Group.pdf
The document discusses the International Medical Device Regulators Forum (IMDRF) and its Medical Device Single Audit Program (MDSAP) Working Group. The IMDRF aims to strategically accelerate international regulatory convergence for medical devices. The MDSAP Working Group is developing a standard set of requirements for auditing organizations to conduct single audits of medical device manufacturers' quality systems. This involves creating recognition criteria for auditing organizations based on standards from ISO, the EU, Health Canada, Japan, the US FDA and others. The goal is to establish a single audit program to improve regulatory convergence.
Ucm072331
This document provides guidance for submitting regulatory information to the FDA in electronic format, specifically focusing on the content of labeling. It outlines that the FDA is transitioning to accepting content of labeling using the Structured Product Labeling (SPL) standard to make the information easier to process, review and exchange between systems. SPL allows labeling information to be submitted in XML format, enabling uses like populating electronic health records and supporting electronic prescribing initiatives. The guidance provides details on file formats, procedures and organizing electronic submissions using SPL.
Certificate of pharmaceutical product
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Pharmaceutical Industry Development
The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.
Similar to Online Application (20)
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...
Regulation Governing Clinical Trials In India,USA and Europe.
Regulation Governing Clinical Trials In India,USA and Europe.
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Premarket Notification 510(k) for Biologics [Autosaved].pptx
Canadian Medical Devices Conformity Assessment System(CMDCAS) - Training mate...
Canadian Medical Devices Conformity Assessment System(CMDCAS) - Training mate...
Overview of Japanese Foreign Manufacturers Accreditation
Overview of Japanese Foreign Manufacturers Accreditation
Presentation: Update from the Medical Devices Branch
Presentation: Update from the Medical Devices Branch
Guidelines for import and manufacture of medical devices
Guidelines for import and manufacture of medical devices
13 Medical Device Single Audit Program (MDSAP) Working Group.pdf
13 Medical Device Single Audit Program (MDSAP) Working Group.pdf
Recently uploaded
Transit-Oriented Development Study Working Group Meeting
This presentation on TOD best practices and model zoning was shared with the Cuyahoga County TOD working group on June 5, 2024.
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHO
The 2024 World Health Statistics edition reviews more than 50 health-related indicators from the Sustainable Development Goals and WHO’s Thirteenth General Programme of Work. It also highlights the findings from the Global health estimates 2021, notably the impact of the COVID-19 pandemic on life expectancy and healthy life expectancy.
About Potato, The scientific name of the plant is Solanum tuberosum (L).
The potato is a starchy root vegetable native to the Americas that is consumed as a staple food in many parts of the world. Potatoes are tubers of the plant Solanum tuberosum, a perennial in the nightshade family Solanaceae. Wild potato species can be found from the southern United States to southern Chile
Synopsis (short abstract) In December 2023, the UN General Assembly proclaimed 30 May as the International Day of Potato.
Combined Illegal, Unregulated and Unreported (IUU) Vessel List.
The best available, up-to-date information on all fishing and related vessels that appear on the illegal, unregulated, and unreported (IUU) fishing vessel lists published by Regional Fisheries Management Organisations (RFMOs) and related organisations. The aim of the site is to improve the effectiveness of the original IUU lists as a tool for a wide variety of stakeholders to better understand and combat illegal fishing and broader fisheries crime.
To date, the following regional organisations maintain or share lists of vessels that have been found to carry out or support IUU fishing within their own or adjacent convention areas and/or species of competence:
Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR)
Commission for the Conservation of Southern Bluefin Tuna (CCSBT)
General Fisheries Commission for the Mediterranean (GFCM)
Inter-American Tropical Tuna Commission (IATTC)
International Commission for the Conservation of Atlantic Tunas (ICCAT)
Indian Ocean Tuna Commission (IOTC)
Northwest Atlantic Fisheries Organisation (NAFO)
North East Atlantic Fisheries Commission (NEAFC)
North Pacific Fisheries Commission (NPFC)
South East Atlantic Fisheries Organisation (SEAFO)
South Pacific Regional Fisheries Management Organisation (SPRFMO)
Southern Indian Ocean Fisheries Agreement (SIOFA)
Western and Central Pacific Fisheries Commission (WCPFC)
The Combined IUU Fishing Vessel List merges all these sources into one list that provides a single reference point to identify whether a vessel is currently IUU listed. Vessels that have been IUU listed in the past and subsequently delisted (for example because of a change in ownership, or because the vessel is no longer in service) are also retained on the site, so that the site contains a full historic record of IUU listed fishing vessels.
Unlike the IUU lists published on individual RFMO websites, which may update vessel details infrequently or not at all, the Combined IUU Fishing Vessel List is kept up to date with the best available information regarding changes to vessel identity, flag state, ownership, location, and operations.
2024: The FAR - Federal Acquisition Regulations, Part 38
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Milton Keynes Hospital Charity - A guide to leaving a gift in your Will
A forever thank you in your Will to Milton Keynes University Hospital can change lives for years to come.
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC Charlotte
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC CharlotteUniversity of North Carolina at Charlotte
Working with data is a challenge for many organizations. Nonprofits in particular may need to collect and analyze sensitive, incomplete, and/or biased historical data about people. In this talk, Dr. Cori Faklaris of UNC Charlotte provides an overview of current AI capabilities and weaknesses to consider when integrating current AI technologies into the data workflow. The talk is organized around three takeaways: (1) For better or sometimes worse, AI provides you with “infinite interns.” (2) Give people permission & guardrails to learn what works with these “interns” and what doesn’t. (3) Create a roadmap for adding in more AI to assist nonprofit work, along with strategies for bias mitigation.
State crafting: Changes and challenges for managing the public finances
Presentation at Resolution Foundation event putting the public finances into context ahead of the next election.
2024: The FAR - Federal Acquisition Regulations, Part 40
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
原版制作(Hope毕业证书)利物浦霍普大学毕业证文凭证书一模一样
学校原件一模一样【微信：741003700 】《(Hope毕业证书)利物浦霍普大学毕业证文凭证书》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
A guide to the International day of Potatoes 2024 - May 30th
Food and Agricultural Organization (FAO)
Texas Water Development Board Updates June 2024
Presented at June 6-7 Texas Alliance of Groundwater Districts Business Meeting
AHMR volume 10 number 1 January-April 2024
AHMR is an interdisciplinary peer-reviewed online journal created to encourage and facilitate the study of all aspects (socio-economic, political, legislative and developmental) of Human Mobility in Africa. Through the publication of original research, policy discussions and evidence research papers AHMR provides a comprehensive forum devoted exclusively to the analysis of contemporaneous trends, migration patterns and some of the most important migration-related issues.
Antyodaya saral portal haryana govt schemes
The Antyodaya Saral Haryana Portal is a pioneering initiative by the Government of Haryana aimed at providing citizens with seamless access to a wide range of government services
Border towns and spaces of (in)visibility.pdf
This report explores the significance of border towns and spaces for strengthening responses to young people on the move. In particular it explores the linkages of young people to local service centres with the aim of further developing service, protection, and support strategies for migrant children in border areas across the region. The report is based on a small-scale fieldwork study in the border towns of Chipata and Katete in Zambia conducted in July 2023. Border towns and spaces provide a rich source of information about issues related to the informal or irregular movement of young people across borders, including smuggling and trafficking. They can help build a picture of the nature and scope of the type of movement young migrants undertake and also the forms of protection available to them. Border towns and spaces also provide a lens through which we can better understand the vulnerabilities of young people on the move and, critically, the strategies they use to navigate challenges and access support.
The findings in this report highlight some of the key factors shaping the experiences and vulnerabilities of young people on the move – particularly their proximity to border spaces and how this affects the risks that they face. The report describes strategies that young people on the move employ to remain below the radar of visibility to state and non-state actors due to fear of arrest, detention, and deportation while also trying to keep themselves safe and access support in border towns. These strategies of (in)visibility provide a way to protect themselves yet at the same time also heighten some of the risks young people face as their vulnerabilities are not always recognised by those who could offer support.
In this report we show that the realities and challenges of life and migration in this region and in Zambia need to be better understood for support to be strengthened and tuned to meet the specific needs of young people on the move. This includes understanding the role of state and non-state stakeholders, the impact of laws and policies and, critically, the experiences of the young people themselves. We provide recommendations for immediate action, recommendations for programming to support young people on the move in the two towns that would reduce risk for young people in this area, and recommendations for longer term policy advocacy.
Recently uploaded (20)
Transit-Oriented Development Study Working Group Meeting
Transit-Oriented Development Study Working Group Meeting
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHO
Monitoring Health for the SDGs - Global Health Statistics 2024 - WHO
About Potato, The scientific name of the plant is Solanum tuberosum (L).
About Potato, The scientific name of the plant is Solanum tuberosum (L).
Combined Illegal, Unregulated and Unreported (IUU) Vessel List.
Combined Illegal, Unregulated and Unreported (IUU) Vessel List.
2024: The FAR - Federal Acquisition Regulations, Part 38
2024: The FAR - Federal Acquisition Regulations, Part 38
Milton Keynes Hospital Charity - A guide to leaving a gift in your Will
Milton Keynes Hospital Charity - A guide to leaving a gift in your Will
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC Charlotte
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC Charlotte
State crafting: Changes and challenges for managing the public finances
State crafting: Changes and challenges for managing the public finances
2024: The FAR - Federal Acquisition Regulations, Part 40
2024: The FAR - Federal Acquisition Regulations, Part 40
A guide to the International day of Potatoes 2024 - May 30th
A guide to the International day of Potatoes 2024 - May 30th
Online Application
- 1. FDA Circular No. 2014- 003 dated 11 February 2014 • Filing and Receiving of Registration, Licensing and Other Applications Using the Integrated Application Form
- 2. I. RATIONALE RA 9485 “ Anti Red tape Act of 2007 improve efficiency in the delivery of government services establish effective practices to prevent graft and corruption
- 3. RA 9485 “ Anti Red tape Act of 2007 • Frontline services shall undergo evaluation and improvement of their transaction systems and procedures to reduce bureaucratic red tape and processing time.
- 4. RA 9711 “ Food and Drug Administration Act of 2009” • Establish and maintain an effective health products and regulatory system • Prescribe standards, guidelines and regulations
- 5. II. OBJECTIVES • Promote accountability and transparency • Integrated Application Form be adopted • Simplify and streamline the requirements for FDA authorization
- 6. III. SCOPE •The following authorizations are serve by the Integrated Application Form. 1. License To Operate 2. Certificate of Product Registration (CPR)
- 7. III. SCOPE 3. Promo and Advertisement Permits 4. Certificate of Free Sale 5. Export Certificate 6. Certificate of Pharmaceutical Products 7. Generic Labeling Exemption
- 8. III. SCOPE 8. Certificate of Compliance with Good Manufacturing Practice (GMP) 9. Certificate of Compliance with Hazard Analysis and Critical Control Points (HACCP)
- 9. IV. GUIDELINES • A. PRINCIPLES 1. The Integrated Application Form is the primary requirement for any authorization issued by FDA. 2. The Integrated Application Form: - electronic file format - publicly accessible - able to be accomplished independent of guidance by an FDA Officer
- 10. 3. Information and documents submitted will be collected and verified. 4. applicant agrees to be bound to the terms of the petition and declaration forms 5. hardcopies shall no longer be required upon submission
- 11. B. REQUIREMENTS 1. Complete application documentary requirements stored in a USB device 2. Two (2) hardcopies of the Document Tracking Log (DTL) issued by FDA 3. Two (2) hardcopies of the accomplished Integrated Application Form (notarized) 4. Original copies of proof of payment 5. One (1) sample in commercial presentation (for CPR application only)
- 12. C. PROCEDURES 1. Download - www.fda.gov.ph - Integrated Application Form 2. Fill-up Form - appropriate, complete and true information 3. Email - send application to pair@fda.gov.ph
- 13. 4. Scheduling - within ten (10) working days of receiptof application form through pair@fda.gov.ph 5. Pay - Land Bank of thePhilippines - FDA Cashier (scheduled to be received for the day)
- 14. 6. Check - completeness of requirements 7. Submission - Application is filed in on schedule. - Only applications scheduled for the day will be accomodated - hard copies will no longer be required at submission