WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25–26 June 2019
National Institute for Biological Standards and Control (NIBSC) ; World Health Organization Switzerland (WHO) ; University of Technology Thonburi ; MSD International GmbH ; National Agency of Drug and Food Control (NADFC) ; Agência Nacional de Vigilância Sanitária (ANVISA) ; General Directorate of Medicines Supplies and Drugs (DIGEMID) ; National Medical Products Administration ; Health Sciences Authority ; Zambia Medicines Regulatory Authority (ZAMRA) ; Food and Drug Administration (FDA) ; World Health Organization Philippines (WHO) ; Ministry of Food and Drug Safety (MFDS) ; Roche Singapore Technical Operations ; National Pharmaceutical Regulatory Agency (NPRA) ; Iran Food and Drug Administration (IFDA) ; International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) ; Pharmaceutical Affairs Central Administration ; Mylan Pharmaceuticals Private Limited ; Korea Vaccine Co ; Jordan Food and Drug Administration (JFDA) ; Health Canada (HC) ; Samsung Bioepis ; Federal Service for Surveillance in Healthcare ; Samsung Biologics ; Serum Institute of India ; Ministry of Public Health (Thailand) ; GC Cell ; Hugel ; ILDONG Pharmaceutical Co ; Novo Nordisk ; Eisai Korea Inc ; ALVOGEN KOREA ; Biocad ; LG Chem ; EuBiologics Co ; Food and Drugs Authority ; ISU ABXIS Co ; Ministry of Health of the Russian Federation ; Hoffmann–La Roche ; Ministry of Health of Ukraine ; SK Bioscience Co ; Central Drug Standards Control Organization (CDSCO) ; ILDONG Pharmaceutical Co ; Celltrion ; National Institute for Biological Standards and Control (NIBSC) ; Pharmaceuticals and Medical Devices Agency (PMDA) ; GC Pharma ; HANDOK Inc.
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The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.
Wadhwa M, Kang H-N, Jivapaisarnpong T, Ahmed A, Andalucia LR, Blades CDRZ, et al. WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019. Biologicals. 2020 May;65:50-59. doi:10.1016/j.biologicals.2019.12.008.
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