Type 1A and 1B variations are minor variations that have minimal or no impact on safety, efficacy, or quality. Type 1A variations are further divided into those requiring immediate notification ("IAIN") and those not requiring it ("IA"). Type II variations are major variations that may significantly impact safety, efficacy, or quality. Extensions apply to changes like new strengths or forms and require full evaluation. Variations are submitted based on classification and some can be grouped together in a single submission. The process involves regulatory submission and approval timelines that differ based on variation type. Marketing authorizations must be renewed every 5 years upon application by the holder to remain valid indefinitely.
The document discusses different types of variations to marketing authorizations for medicinal products in the EU. Variations are classified as minor (Type I) or major (Type II), with Type I divided into IA and IB categories based on the approval process required. The presentation covers definitions of variations, examples of different variation types, procedures for filing variations, and grouping of variations in a single application.
The document provides information on variations and renewals of marketing authorizations in the European Union. It discusses the different types of variations (Type IA, IB, II and extensions), including examples. It describes the classification guidelines and regulations governing variations in the EU. It also outlines the documentation requirements, timelines and procedures for notification and approval of variations. Finally, it discusses marketing authorization renewals in the EU, noting they must be applied for at least 9 months before expiration for the authorization to remain valid indefinitely.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
The document discusses different types of variations to marketing authorizations for medicinal products in the EU. Variations are classified as minor (Type I) or major (Type II), with Type I divided into IA and IB categories based on the approval process required. The presentation covers definitions of variations, examples of different variation types, procedures for filing variations, and grouping of variations in a single application.
The document provides information on variations and renewals of marketing authorizations in the European Union. It discusses the different types of variations (Type IA, IB, II and extensions), including examples. It describes the classification guidelines and regulations governing variations in the EU. It also outlines the documentation requirements, timelines and procedures for notification and approval of variations. Finally, it discusses marketing authorization renewals in the EU, noting they must be applied for at least 9 months before expiration for the authorization to remain valid indefinitely.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. There are different categories of applications for prescription medicines - Category 1 involves new drugs or changes requiring clinical data review, Category 2 involves identical drugs already approved in other countries, and Category 3 involves quality changes only. Applications are processed within statutory timeframes, and variations to approved drugs can be major requiring full review, or minor involving low-risk changes with streamlined processes. Fees are charged depending on the type and complexity of the application or variation.
This document provides an overview of marketing authorization procedures and premarketing requirements for drug product registration in Southeast Asian countries. It discusses the regulatory framework in the ASEAN region and details the marketing authorization processes in major Southeast Asian countries like Singapore, Malaysia, Thailand, Indonesia, and the Philippines. The key steps involved are application submission, evaluation, and the regulatory decision. Requirements like dossier format, samples, certificates, and administrative documents are also summarized. Finally, some regulatory challenges around GMP compliance, labeling requirements, authorization timelines, and country-specific rules are highlighted.
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
Marketing Authorization Procedure in European UnionDoninder Hooda
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.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
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.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
The document discusses drug registration processes and formats used in ASEAN countries. It provides information on the individual drug registration systems of each ASEAN member state, which countries have their own formats versus following the common ASEAN CTD format. Export of Indian AYUSH products to ASEAN countries has increased significantly between 2004-2008. The common ASEAN CTD format is described in detail with its section headings.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
Comparison of Drug Approval Process in United States & EuropeChandra Mohan
The document discusses the drug approval process and types of variations in the European Union. It outlines 4 types of variations: Type I A/B, which are minor variations that can be implemented with notification; Type II, which are major variations requiring approval; and Extensions, which require evaluation similar to the initial approval. It provides examples and timelines for processing the different variation types, which range from 30 days for Type I to 90 or 120 days for complex Type II variations. Renewals of marketing authorizations are valid for 5 years and can be renewed upon application by the holder.
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
The Therapeutic Goods Administration (TGA) regulates medicines and medical devices in Australia. There are different categories of applications for prescription medicines - Category 1 involves new drugs or changes requiring clinical data review, Category 2 involves identical drugs already approved in other countries, and Category 3 involves quality changes only. Applications are processed within statutory timeframes, and variations to approved drugs can be major requiring full review, or minor involving low-risk changes with streamlined processes. Fees are charged depending on the type and complexity of the application or variation.
This document provides an overview of marketing authorization procedures and premarketing requirements for drug product registration in Southeast Asian countries. It discusses the regulatory framework in the ASEAN region and details the marketing authorization processes in major Southeast Asian countries like Singapore, Malaysia, Thailand, Indonesia, and the Philippines. The key steps involved are application submission, evaluation, and the regulatory decision. Requirements like dossier format, samples, certificates, and administrative documents are also summarized. Finally, some regulatory challenges around GMP compliance, labeling requirements, authorization timelines, and country-specific rules are highlighted.
Registration procedure of drugs in european unionbdvfgbdhg
This document outlines various procedures for registering medicinal products in the European Union. It describes the centralized procedure administered by the European Medicines Agency and national procedures administered by individual member states. It also covers the mutual recognition and decentralized procedures which allow registration in multiple member states based on one member state's assessment. There are also simplified registration procedures for certain herbal medicinal products.
European Medicines Agency has issued a new guidelines describing stability testing requirements for variations to a marketing authorisation after approval, setting out the differing requirements for changes to active pharmaceutical ingredients (API) and finished dosage form production.
Manufacturers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to these new guidelines.
Marketing Authorization Procedure in European UnionDoninder Hooda
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.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
The document provides information about the European Medicines Agency (EMA) and marketing authorization procedures in the European Union. It describes the EMA's role in evaluating and authorizing medicines, its committees and membership. Four procedures for marketing authorization are outlined: centralized, national, mutual recognition and decentralized. The centralized procedure allows marketing across the EU, while national and decentralized are for individual countries. Mutual recognition relies on an existing national authorization. Timelines for evaluation are included.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Content and format of dossier filling in india sandeep bansal
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
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.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
The document discusses drug registration processes and formats used in ASEAN countries. It provides information on the individual drug registration systems of each ASEAN member state, which countries have their own formats versus following the common ASEAN CTD format. Export of Indian AYUSH products to ASEAN countries has increased significantly between 2004-2008. The common ASEAN CTD format is described in detail with its section headings.
NSF certification, Standard for dietary supplementAtul Bhombe
NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
Comparison of Drug Approval Process in United States & EuropeChandra Mohan
The document discusses the drug approval process and types of variations in the European Union. It outlines 4 types of variations: Type I A/B, which are minor variations that can be implemented with notification; Type II, which are major variations requiring approval; and Extensions, which require evaluation similar to the initial approval. It provides examples and timelines for processing the different variation types, which range from 30 days for Type I to 90 or 120 days for complex Type II variations. Renewals of marketing authorizations are valid for 5 years and can be renewed upon application by the holder.
Product lifecycle management: process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.
The document discusses the role of Chemistry, Manufacturing, and Controls (CMC) regulatory affairs in managing post-approval changes to drugs. It explains that CMC regulatory affairs professionals work to assure drug quality from clinical trials through marketing by determining the appropriate regulatory submissions for manufacturing changes. They assess proposed changes and provide initial and final responses on whether a prior approval supplement, changes-being-effected supplement, annual report, or no submission is required. This change control process involves interactions with manufacturing and consideration of regulations, guidance, and potential effects on drug quality and equivalence.
Presentation: Update from the Complementary and OTC Medicines Branch: Listed ...TGA Australia
This session will provide an overview of the status of reform initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to complementary medicines
The document provides summaries of regulatory updates from 2015, including:
- New and revised FDA, Eudralex, WHO, and Indian Gazette guidelines.
- ICH announced organizational changes to become more globally inclusive.
- FDA released a new method validation guideline for biologics and updated requirements for quality metrics reporting.
- Eudralex provided new guidance on excipient GMP and prevention of cross-contamination in facilities and production.
Medicines and Medical Devices Regulation – current developments and future op...TGA Australia
1. The document summarizes recent developments and future options in medicines and medical devices regulation in Australia, as presented by John Skerritt from the Department of Health.
2. Key updates included planned changes to medicines labeling, reviews of programs for orphan drugs and recalls, and a new online system for clinical trial notifications.
3. The presentation also discussed an expert panel review that recommended modernizing approval pathways for new drugs and generics, adopting risk-based approaches, and reforms to schemes for unapproved products.
The SUPAC guidelines provide recommendations for post-approval changes to NDAs and ANDAs, including changes to components, manufacturing processes, batch size, and manufacturing sites. The guidelines classify changes as minor (Level 1), moderate (Level 2), or major (Level 3) based on their potential effect on product quality and performance. Level 1 changes require chemistry and dissolution documentation, while Level 2 changes may also require in vivo bioequivalence testing or stability testing. Level 3 changes always require bioequivalence testing and prior approval before implementation. The guidelines aim to streamline regulatory processes for industry while ensuring safety and effectiveness.
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
The document discusses post-approval regulatory affairs. It notes that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved drugs and devices. Failure to comply with post-approval requirements can result in withdrawal of approval. It also discusses requirements for making and reporting manufacturing and distribution changes to approved applications, including prior approval supplements, changes being effected supplements, and annual reports. Finally, it provides examples of major, moderate, and minor labeling changes that may require different levels of regulatory submission.
The document discusses guidelines for supplemental new drug applications (sNDAs) according to the US FDA. It outlines three categories of variations - major, moderate, and minor - based on their potential impact. Major changes require prior approval and could impact safety or efficacy. Moderate changes require submission 30 days before distribution or upon FDA receipt. Minor changes only require description in the annual report. The document provides examples of changes in manufacturing sites, processes, specifications, container closure systems, and labeling that would fall under each category. Close monitoring and reporting of any post-approval changes is recommended to ensure the quality, safety and efficacy of pre-qualified products are not adversely affected.
Regulatory updates from the Complementary and OTC Medicines Branch - Listed m...TGA Australia
The document discusses several regulatory reforms for listed medicines in Australia, including:
1. Permitted indications which provide a list of approved health benefit claims for listed medicines and require sponsors to select from this list, improving transparency.
2. An assessed listed pathway which allows pre-market evaluation of efficacy claims, providing access to higher-level health claims.
3. A "TGA assessed" label claim indicating the medicine's efficacy has been evaluated, improving consumer awareness and confidence.
4. Two years of market exclusivity for sponsors who apply for and are approved for new permitted ingredients.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It outlines the types of post-approval changes that require an SNDA including manufacturing process or formulation changes. Major changes with potential safety or efficacy impacts require prior approval, while moderate changes require 30 days notice and minor changes are reported annually. The guidance provides categories and examples to help classify different variation types.
SUPAC, BACPAC, Post Marketing SurveillanceMANIKANDAN V
This document discusses various guidelines related to product development and technology transfer in the pharmaceutical industry. It covers SUPAC, BACPAC, and post-marketing surveillance. SUPAC provides guidance for scale-up and post-approval changes, categorizing changes into different levels based on their potential impact. BACPAC guidance addresses post-approval changes for bulk active pharmaceutical ingredients. Post-marketing surveillance involves monitoring adverse drug events after approval to ensure ongoing safety and effectiveness.
The document discusses guidelines for supplemental new drug applications (sNDAs) submitted to the FDA for post-approval changes. It categorizes changes as major, moderate or minor based on their potential impact. Major changes like new manufacturing sites or processes require prior approval. Moderate changes require submission 30 days before distribution or when received by FDA. Minor changes are described in annual reports. The types and levels of data required to support each change category are also outlined.
This document provides guidance on best practices and strategies for post-approval changes to approved drug applications. It discusses regulations and common types of post-approval changes. It also provides examples of changes that fall under different reporting categories and discusses key considerations for submitting supplements and avoiding common deficiencies. The document emphasizes using risk-based approaches and submitting complete information to facilitate efficient review of proposed changes.
This document provides an overview of the International Council for Harmonisation (ICH). It explains that ICH aims to reduce differences between countries' regulatory guidelines for pharmaceuticals through harmonization. It describes ICH's organization, including its members, observers, and management committees. Finally, it outlines ICH's harmonization process and lists some of its guidelines and successes in harmonizing technical requirements to help ensure safe, effective medicines for patients worldwide.
The document provides an overview of India's drug regulatory system, including:
- The Central Drugs Standard Control Organization (CDSCO) regulates drug approval, clinical trials, GMP, and other functions. It is headed by the Drug Controller General of India.
- The drug approval process involves submitting an application, treasury challan, and details on bulk drug sources. The Drugs and Cosmetics Act of 1940 and Rules of 1945 provide the legal framework and establish licensing requirements.
- There are various types of manufacturing, sale, import, and testing licenses issued under the Act based on the schedule and category of drugs. The organizational structure, approval process, legal framework and license types are described.
The document discusses regulations for drug submissions and applications in the US and other countries. It covers the major regulatory bodies like the FDA and EMA. It then focuses on the different types of applications filed with the FDA - Drug Master Files (DMF), Investigational New Drug Application (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). The ANDA process for generic drugs is summarized, including requirements for bioequivalence testing and patent certification in the Orange Book.
The document summarizes the ICH eCTD specification, which provides criteria for making electronic submissions technically valid. It lists requirements for common file formats, fonts, links, font size, color, page orientation, margins, bookmarks, page numbering, document fields, and security settings. The goal is to enable effective electronic transfer of registration applications from industry to regulatory authorities.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The document discusses the Common Technical Document (CTD), which is an internationally agreed format for organizing technical documents submitted to regulatory authorities for drug approval. It aims to harmonize submissions across regions to streamline the review process. The CTD format includes five modules covering administrative information, summaries, quality, nonclinical studies, and clinical studies. It provides benefits like reducing application preparation time and facilitating simultaneous multi-regional submissions and information exchange between authorities.
Regulatory affairs emerged from disasters in the pharmaceutical industry that caused increased legislation around drug safety and quality. Key events that shaped regulations include contaminated vaccines that killed children, unsanitary meat production exposed in The Jungle, an improperly prepared sulfanilamide medicine that killed over 100 people, the thalidomide morning sickness drug that caused birth defects, problematic intrauterine devices like the Dalkon Shield, and mechanical heart valves like the Bjork-Shiley that malfunctioned. Regulatory affairs acts as the interface between industry and drug authorities, ensuring the registration, safety, efficacy and quality of pharmaceutical products according to legislative requirements in different countries.
ICH Q6A Specifications by Chandra MohanChandra Mohan
The document provides guidelines on specifications for new drug substances and products. It defines specifications and outlines universal tests that should be included for both drug substances and products, such as description, identification, assay, and impurities. It also describes specific tests that may be included depending on the dosage form, such as dissolution, disintegration, hardness/friability for solid oral dosage forms. The guidelines provide information on justifying acceptance criteria and setting specifications based on development data and stability studies.
Regulatory affairs ensures that pharmaceutical products meet legislative requirements by studying scientific and legal documents, gathering and organizing submission documents, and collating information for regulatory authorities. The Common Technical Document format is used for new drug applications and provides a harmonized structure for applications submitted to agencies like the US FDA and EMA. The US FDA filing process involves applications like Investigational New Drug Applications, New Drug Applications, and Abbreviated New Drug Applications for generic drugs. Regulatory authorities differ between fully regulated markets and semi-regulated markets.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
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.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
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2. • What is a Variation…?
• Variation Guidelines
• Types of variations
Type-1A
Type-1B
Type-II
Extension
• Renewals
3. What is a Variation…?
• A variation is a change to the terms of a marketing authorisation. This section
provides guidance for marketing authorisation holders on the regulatory
requirements and procedures for the different types of variations.
4. Variations in European Union (EU) are regulated by following regulations and Guidelines:
• Commission Regulation (EC) No. 712/2012 of 3 August 2012 amending Regulation (EC) No.
1234/ 2008 concerning examination of variations to the terms of marketing authorisations for
medicinal products for human use and veterinary medicinal products.
Annex I – Extensions of marketing authorisations.
Annex II – Classification of variations.
Annex III – Cases for grouping variations.
Annex IV – Elements to be submitted.
Annex V – Variations concerning a change to or addition of therapeutic indication, addition of non-
food producing target species, replacement or addition of a stereotype, strain, antigen etc.
• Guidelines of 16.05.2013 on the details of the various categories of variations, on the operation of
the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 234/2008
of 24 November 2008 concerning the examination of variations to the terms of marketing
authorisations for medicinal products for human use and veterinary medicinal products and on the
documentation to be submitted pursuant to those procedures.
7. Types of variations
Variations are broadly classified in to two categories:
Minor Variations: Type-1A & Type-1B variations
Major Variations: Type-II variations
8. Type IA variations
Type IA variations: Type IA variations are the minor variations which have only a
minimal impact or no impact at all, on the quality, safety or efficacy of the medicinal
product, and do not require prior approval before implementation ("Do and Tell"
procedure).
Such a minor variations are “classified” two subcategories, which impact on their
submission:
• Type IA variations requiring immediate notification (‘IAIN’)
• Type IA variations NOT requiring immediate notification (‘IA’) (Variations which
do not require immediate notification may be submitted by the marketing authorisation
holder (MAH) within 12 months after implementation).
9. Type IA variations
Why certain minor variations of Type IA require immediate notification ?
Certain minor variations of Type IA require immediate notification after implementation, in
order to ensure the continuous supervision of the medicinal product.
When should I submit my Type IAIN variation?
This should be submitted immediately and generally within 2 weeks of implementation of the
change.
What is meant by 'implementation' for Type IA variations?
For quality changes, implementation is when the company makes the change in its own
quality system.
10. Examples of Type IA Variations
Examples of Type IAIN Variation:
• Change in the name and/or address of the marketing authorisation holder
• Change in the name and/or address of a manufacturer/importer of the finished product (including
batch release or quality control testing sites)
• Changes in imprints, bossing or other markings
• Change in the shape or dimensions of the pharmaceutical form particularly Immediate release
tablets, capsules, suppositories and pessaries.
Examples of Type IA Variation:
• Addition of physico-chemical test in specification.
• Deletion of non-significant test (ex: Identification test in Stability study).
• Tightening of specification limits (ex: Tightening of test limit for water content, Residual solvents
and Related substances..etc.
• CEP updates/renewal.
• API and FP Batch size increase/decrease within 10 fold.
11. Type IB Variations
• Commission Regulation (EC) No 1234/2008 ('the Variations Regulation') defines a
minor variation or Type IB as a variation which is neither a Type IA variation nor
Type II variation nor an Extension.
• Such minor variations must be notified to the National Competent Authority/
European Medicines Agency by the Marketing Authorisation Holder (MAH)
before implementation.
• However, the MAH must wait a period of 30 days to ensure that the notification is
acceptable by the Agency before implementing the change (Tell, Wait and Do
procedure).
12. Examples of Type IB Variations
Type IB Changes - Min to moderate impact on product quality (Tell, Wait and
Do procedure):
• Major change the approved analytical method
• FP Mfg. site changes
• Shelf-life extension
• Change in storage condition
• Minor changes to approved manufacturing process
• Change in batch size beyond 10 fold category
• SmPC /PIL changes in-line with innovator product
13. Type II Variations
• Commission Regulation (EC) No 1234/2008 ('the Variations Regulation')
defines a major variation of Type II as a variation which is not an extension
and which may have a significant impact on the Quality, Safety or Efficacy of
a medicinal product.
Examples of Type II Variations
Type II Changes (Significant impact on product quality, safety & efficacy):
• Addition of alternate/new API DMF supplier
• Relaxation of approved specification
• Major change in approved manufacturing process
• Major change in approved composition
14. Extension Applications
Changes to a marketing authorisation listed in Annex I of Commission Regulation (EC) No
1234/2008 are regarded as "extensions" of the marketing authorisation.
Examples of extension changes:
1. Changes to the active substance(s)
• Replacement of a chemical active substance by a different salt/ester complex/derivative. with the
same therapeutic moiety, where the efficacy/safety characteristics are not significantly different;
2. Change to strength, pharmaceutical form, route of administration
• Change of bioavailability;
• Change of pharmacokinetics e.g. change in rate of release;
• Change or addition of a new strength/ potency;
• Change or addition of a new pharmaceutical form;
• Change or addition of a new route of administration.
• Such applications will be evaluated in accordance with the same procedure as for the granting of
the initial marketing authorisation to which it relates.
• The extension can either be granted as a new marketing authorisation or will be included in the
initial marketing authorisation to which it relates.
15. Grouping of variations
• It is possible to group variations of different categories the same marketing authorisation (MA) and
submit them in one submission, under a single application form, to the same relevant authority.
This is permissible where variations are covered under the cases listed in Annex III to the
variations regulation.
• Examples are any group of IA changes, a group comprising a Type IB or Type II change plus one
or more of the same or lower category which are consequential to the first, and a group of
administrative changes to labelling.
• If a projected group is not listed in Annex III, the regulation and supporting guidances permit the
MAH to request agreement of the relevant authority(ies) to grouping of related changes where a
single data package and evaluation are meaningful.
• 14 cases of Groupings listed in Annex III
• CMDh Guidance for Examples for Acceptable and Not-Acceptable Groupings for MRP/DCP
Products -Doc. Ref: CMDh/173/2010/Rev.10 July 2013
16. The following documents should be submitted for filing of Variations applications:
• Cover letter.
• The completed EU variation application form
• Reference of variation guidelines, indicating that all conditions and documentation requirements
are met.
• Relevant documentation in support of the proposed variation including any documentation
specified in the Annex to these guidelines.
• In case that the variations affect the summary of product characteristics, labelling or package
leaflet: the revised product information presented in the appropriate format.
• Update or Addendum to the detailed critical summaries (quality, safety, efficacy as appropriate)
Examples of the variation applications:
Type IA
Type IB
Type II
Documentation Required For Variation Filling
17. How shall my Type IA/ IAIN notification be processed (timetable) by Health Authority?
• A ‘notification of receipt’ letter would be issued by the Agency within five days of receipt of a
Type IA application.
• Within 30 days of receipt, the notification would be reviewed. The Health authority will check
the correctness of the application form, ensure the required documentation is present and
compliance with the required conditions.
• The outcome of the process, an approval and/or refusal, would be communicated to the MAH via
the post or the portal.
• There will be no interaction with the marketing authorisation holder (MAH) during the
procedure, and no request to provide missing information.
• Type IA notification is a ‘Do and tell’ procedure, therefore changes must be implemented prior to
submission of notification.
Variation Approval Timeline
Receipt of Type IA variation notification Day 0
Start of MHRA check Day 1
Acknowledgement of acceptance or refusal By Day 30
18. Variation Approval Timeline
How shall my Type IB notification be processed (timetable) by Health
Authority?
• For Type IB notifications, the target pre-assessment processing time is 14 days.
• Substantive assessment is done within 30 days, and leads either to approval or a
Request For Further Information (RFI) letter within that 30 days.
• The company’s response to the RFI letter needs to be received within 30 days.
• Assessment of that response is within a further 30 days.
19. Variation Approval Timeline
How shall my Type II notification be processed (timetable) by Health Authority?
Type II variations follow a 30-day, 60-day or 90-day procedure (Depending upon
complexity of the variation application)
Stage 30-Day procedure 90-Day procedure 120-Day procedure
Start assessment – clock on Day 0 Day 0 Day 0
Assessment done
Approved, refused or withdrawn (procedure finalised) Day 22 Day 60 Day 90
or
Request for further information (RFI) issued – clock off
(procedure suspended)
Day 21 Day 59 Day 89
Amended application for applications with an RFI step
Timescale for receipt of response 10 days 60 days 90 days
Response received – clock on completion of processing
(excluding clock off time)
By day 30
By day 90 By day 120
20. EU: Renewals
Introduction
• A marketing authorisation is valid for five years, and is renewable upon application by
the Marketing Authorisation Holder.
• Once renewed the marketing authorisation will be valid for an unlimited period,
unless the competent authority decides, on justified grounds relating to
pharmacovigilance.
• The authorisation may be renewed upon application by the marketing authorisation
holder at least nine months before its expiry.
• In the case a MAH does not submit the renewal application, the MA will expire by
law.
• Certain changes to the marketing authorisation particulars may be made at renewal,
and these changes shall not trigger a variation procedure.