These questions and answers should be read in conjunction with the European Commission . PDF Asean Guidelines on Green Meetings It is determined by a series of tests conducted, namely to ensure maintenance of the specifications of the ศูนย์การศึกษาต่อเนื่องทางเภสัชศาสตร์ ASEAN Revises the ASEAN Variation Guidelines and Issued ... YSEALI YOUnified 2020 A Guide to Planning a Community Service Activity The Young Southeast Asian Leaders Initiative (YSEALI) is the U.S. government's signature program to strengthen leadership development and networking in Southeast Asia. The Guidelines distil the global best . The 'timeline' and 'implementation of the variationis subject to . PDF Association of South East Asian Nations (ASEAN) Meetings - ASCC ISBN 978-602-5798-61- Supported by: ASEAN: A Community of Opportunities for All The map in this publication is only indicative and is not drawn to scale. PDF ASEAN Variation Guidelines For Pharmaceutical Products 8. This guideline . 1 and. ASEAN Guidelines on Stability Study and Shelf-Life of Traditional Medicines 3 of 21 Version 1.0 INTRODUCTION Stability is an essential factor of quality in traditional medicines (TM). Guidance documents for therapeutic products. (iii) Q&A for the Stability Guideline on Vaccine. ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS 7.2 DRAFT JULY 2012 7.2 draft 3.1 3.2 MaV-1 MaV-2 MaV-3 MaV-4 MaV-5 MaV-6 MaV-7 MaV-8 MaV-9 MaV-10 MaV-11 MaV-12 MaV-13 MaV-14 MaV-15 MaV-16 MiV-PA1 MiV-PA2 LIST OF CONTENTS INTRODUCTION SCOPE OF THIS GUIDELINE DEFINITION Major Variation (MaV) Minor Variation (MiV-PA & MiV-N) PROCEDURE AND TIMELINE CHANGES LEADING TO A NEW PRODUCT . ASEAN - Wikipedia 43 Variation are classified in two broad categories - major and minor. of the European Union - EUR-Lex The ASEAN ACCSQ-PPWG has endorsed the following documents. PDF ASEAN: A Community of Opportunities for All A variation is a change to the terms of a marketing authorisation. 4.2 A declaration letter undersigned by the Head of Regulatory officer that declares there is no other The rodmap for an ASEAN Community (2009-2015) was declared by the leaders in 2009. ACTD- ASEAN - SlideShare Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. 1.5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30oC/75% RH). Guideline on the Registration of Human Plasma-derived Therapeutic Products 79 KB. 1; (ii) ASEAN Common Technical Dossier (ACTD) Rev. A variation is a change to the terms of a marketing authorisation. 14 Oct 2020 ASEAN Revises the ASEAN Variation Guidelines and the ACTD The ASEAN ACCSQ-PPWG had endorsed intercessionally the (i) the ASEAN Variation Guideline (AVG) Rev. The ASEAN Common Guidelines are intended to supplement the The ASEAN Community, anchored on three community pillars: Political-Security Community, Economic Community, Socio-Cultural Community was launched in 2015. OBJECTIVES This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different Guidance documents for therapeutic products. 43 Variation are classified in two broad categories - major and minor. 9. 2 PURPOSE This handbook was created to bridge the identified gaps/conflicts in the adoption of ASEAN Variation Guidelines and the prevailing Philippine policies on Pharmaceutical products. ASEAN Variation Guideline for Pharmaceutical Products 2013(Final Draft 7.2) i LIST OF CONTENTS Page 1 INTRODUCTION 1 2 SCOPE OF THIS GUIDELINE 1 3 DEFINITION 1 3.1 Major Variation (MaV) 1 3.2 Minor Variation (MiV-PA & MiV-N) 1 4 PROCEDURE AND TIMELINE 2-3 5 CHANGES LEADING TO A NEW PRODUCT REGISTRATION 3 . 8. Variation shall be submitted online via Quest 3+. 2013/C 223/01 Guidelines 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 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal 21.11.18 ASEAN Games Arrive in Busan. ASEAN Variation Guideline for Pharmaceutical Products (R1) i LIST OF CONTENTS Page 1 INTRODUCTION 1 2 SCOPE OF THIS GUIDELINE 1 3 Definition 1 3.1 Major Variation (MaV) 1 3.2 Minor Variation (MiV-PA & MiV-N) 1 4 PROCEDURE AND TIMELINE 2-3 5 CHANGES LEADING TO A NEW PRODUCT REGISTRATION 3 . This guidance document is adopted from the ASEAN Variation Guideline for Pharmaceutical Products 2012 incorporating Malaysia's specific requirements. OBJECTIVES This guideline is intended to provide recommendations on the core stability study package required for drug products, but leaves sufficient flexibility to encompass the variety of different The documents can be downloaded from the ASEAN secretariat website using the . An aging population and greater incidence of lifestyle-related diseases coupled Variations for human medicines. ASEAN variation guidelines are applicable to pharmaceutical products for human use only, excluding biologics. The ASEAN ACCSQ-PPWG had endorsed intercessionally the. It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. ASEAN variation guidelines are applicable to pharmaceutical products for human use only, excluding biologics. 3 Philippine Variation Guideline . ASEAN (/ ˈ ɑː s i ɑː n / AH-see-ahn, / ˈ ɑː z i ɑː n / AH-zee-ahn), officially the Association of Southeast Asian Nations, is an economic union comprising 10 member states in Southeast Asia, which promotes intergovernmental cooperation and facilitates economic, political, security, military, educational, and sociocultural integration between its members and other countries in Asia. This guidance document is adopted from the ASEAN Variation Guideline for Pharmaceutical Products 2012 incorporating Malaysia's specific requirements. The requirements can be viewed in Malaysian Variation Guideline ( MVG). 21.11.29 ASEAN-Korea Centre opens pitch contest for ASEAN startups. 3 Philippine Variation Guideline . VARIATION. ASEAN Pharma Report CPhI South East Asia 4 Opportunities and threats 2020 and beyond Philippines The demand for healthcare in the Philippines is rapidly increasing for many of the same reasons as most other Southeast Asian countries. No. 2. The ASEAN 2025: Forging Ahead Together was introduced in 2015 as a Post-2015 Vision. This publication is printed using environment-friendly paper. ASEAN Variation Guideline for Pharmaceutical Products (R1) i LIST OF CONTENTS Page 1 INTRODUCTION 1 2 SCOPE OF THIS GUIDELINE 1 3 Definition 1 3.1 Major Variation (MaV) 1 3.2 Minor Variation (MiV-PA & MiV-N) 1 4 PROCEDURE AND TIMELINE 2-3 5 CHANGES LEADING TO A NEW PRODUCT REGISTRATION 3 . This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations. ASEAN Variation Guideline for Pharmaceutical Products, 2012 - Final Adopted Document Implementation of the variation . For Minor Variation- Prior Approval: RM150/ application. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (PDF/2.42 MB) (updated) 'Variations guidelines' - Guidelines 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 1234/2008 of 24 . Guideline on the Registration of Human Plasma-derived Therapeutic Products 79 KB. DEfINITION 3.1 Major variation (MaV) Variation to a registered pharmaceutical finished product that may PHILIPPINE VARIATION GUIDELINES Version 1.0 22 April 2020 . Through a variety of programs and engagements, YSEALI seeks to build the leadership capabilities of youth . 67 s. 1989, "Revised Rules and Regulations on Registration of this guideline addresses the information to be submitted during application for marketing authorization/registration and variations of drug products in asean member states including examples of a protocol of stability study, a report format, reduced design and extrapolation of data, and examples of types, thickness … What is the procedure of Variation? This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal products about classification of changes to the Marketing Authorisation post-authorisation and certain variation classification categories. 2; endorsed at the 31st PPWG Meeting, and (ii) Q&A for the Stability Guideline; endorsed intersessionally in August 2020. (i) the ASEAN Variation Guideline (AVG) Rev. . (i) the ASEAN Variation Guideline (AVG) Rev. Major Variation (MaV) means having significant impact on the aspect of finished product quality, safety and efficacy. However, the legislation governing European variation procedures was not fully adopted at 21.09.28 2021 ASEAN Week (October 4-8) 21.11.29 Preparing for ASEAN-Korea tourism revitalization during the 'Living with COVID-19' era. ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS FINAL DRAFT 7.2 2013 ASEAN Variation Guideline for Pharmaceutical Products 2013(Final Draft 7.2) LIST OF CONTENTS Page 1 INTRODUCTION 1 2 SCOPE OF THIS GUIDELINE 1 3 DEFINITION 1 3.1 Major Variation (MaV) 1 3.2 Minor Variation (MiV-PA & MiV-N) 1 4 PROCEDURE AND TIMELINE 2-3 5 CHANGES LEADING TO A NEW PRODUCT REGISTRATION 3 6 OTHERS 3 7 . This ASEAN Variation Guideline concerns the variation applications submitted by the marketing authorization holder for pharmaceutical products for human use only and not including biologics. The ASEAN ACCSQ-PPWG has endorsed the following documents. For Minor Variation- Notification: FOC. This ASEAN Variation Guideline concerns the variation applications submitted by the marketing authorization holder for pharmaceutical products for human use only and not including biologics. ASEAN Stability Guideline, Bracketing & Matrixing Design, Photo Stability, Registration for Chemical Drug Product , ASEAN Variation Guideline วิธีสมัครการประชุม สมัครออนไลน์ผ่านทางเว็บไซต์ www.rapatregistration.com Philippine Variation Guidelines following the latest version of the ASEAN Variation Guidelines for Pharmaceutical Products and consistent with country-specific regulations and the provisions as stated in Administrative Order (A.O.) ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS FINAL DRAFT 7.2 2013 ASEAN Variation Guideline for Pharmaceutical Products 2013(Final Draft 7.2) LIST OF CONTENTS Page 1 INTRODUCTION 1 2 SCOPE OF THIS GUIDELINE 1 3 DEFINITION 1 3.1 Major Variation (MaV) 1 3.2 Minor Variation (MiV-PA & MiV-N) 1 4 PROCEDURE AND TIMELINE 2-3 5 CHANGES LEADING TO A NEW PRODUCT REGISTRATION 3 6 OTHERS 3 7 . 44 Note: 1. 1; (ii) ASEAN Common Technical Dossier (ACTD) Rev. The primary purpose of the Guidelines is to promote investment in food, agriculture - including fisheries and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. . 9. A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack of predictability of timelines for regulatory review and approval. ANNEX 18 Guideline on Application for Variation to Registered Medicinal Products . 3. Jakarta : ASEAN Secretariat, April 2020 341.7588 1. Share. 1.5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30oC/75% RH). Variations for human medicines. What is the fee for variation applications? 2 PURPOSE This handbook was created to bridge the identified gaps/conflicts in the adoption of ASEAN Variation Guidelines and the prevailing Philippine policies on Pharmaceutical products. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations. 1. 2. PHILIPPINE VARIATION GUIDELINES Version 1.0 22 April 2020 . ACTD ASEAN Common Technical Dossier ACTR ASEAN Common Technical Requirements ASEAN Association of Southeast Asian Nations ATC Anatomical Therapeutic Chemical The two documents, "ASEAN General Guideline on Food Contact Materials" and "ASEAN Guidelines for Good Manufacturing Practice for Food . (i) the ASEAN Variation Guideline (AVG) Rev. ASEAN - Guidelines 2. 2; endorsed at the 31st PPWG Meeting, and (ii) Q&A for the Stability Guideline; endorsed intersessionally in August 2020. Major Variation (MaV) means having significant impact on the aspect of finished product quality, safety and efficacy. 21.11.29 AKC Centre, ASEAN Reflected in the Eyes of Youth. ASEAN COMMON TECHNICAL DOSSIER PREAMBLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well- structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. The primary purpose of the Guidelines is to promote investment in food, agriculture - including fisheries and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. Share. 1 and (iii) Q&A for the Stability Guideline on Vaccine Within a duration subject to country specific proposal after the marketing authorization holder has been informed of the approved variations. Supporting Documents 4.1 The documents required to be submitted for the various types of variation are stated in Appendix 5. Revised topics are marked 'New' or 'Rev.' upon publication. 4TH EDITION (SEPTEMBER 2020) . 44 Guideline on Application for Variation to Registered Medicinal Products 4. 8. On April 12 th, 2021 The Prepared Foodstuffs Product Working Group (PFPWG) of the Association of Southeast Asian Nations (ASEAN) made available online two guidelines for the control systems for food contact materials (FCMs) within ASEAN Member States. ASEAN - Intellectual Property - IP Rights . ASEAN Revises the ASEAN Variation Guidelines and the ACTD. 2. ASEAN Guidelines on Green Meetings Jakarta, ASEAN Secretariat, June 2020 352.1159 1. DEfINITION 3.1 Major variation (MaV) Variation to a registered pharmaceutical finished product that may The rodmap for an ASEAN Community (2009-2015) was declared by the leaders in 2009. The ASEAN 2025: Forging Ahead Together was introduced in 2015 as a Post-2015 Vision. defines variation types, a guideline lays out a harmonised list of anticipated variations with classification codes.1 A defined list of variations for European MAs has existed since implementation of the Mutual Recognition Procedure (MRP) in 1998. 2.3.3 Spelling Variations in Descriptive Words 94 2.3.4 Descriptive Word Elements 96 . It is intended to provide supportive information on the requirements for submission of a variation application to implement a change to a pharmaceutical product. The ASEAN Community, anchored on three community pillars: Political-Security Community, Economic Community, Socio-Cultural Community was launched in 2015. Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. 3. 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