WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.

Autor:	Wadhwa M; National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom. Electronic address: Meenu.Wadhwa@nibsc.org., Kang HN; World Health Organization, Avenue Appia 20, CH-1211, Geneva, Switzerland. Electronic address: kangh@who.int., Jivapaisarnpong T; National Biopharmaceutical Facility, King Mongkut's University of Technology Thonburi, Bangkhuntian, Bangkok, 10150, Thailand. Electronic address: teeranart.j@gmail.com., Andalucia LR; National Agency of Drug and Food Control (NADFC), Indonesia., Blades CDRZ; Brazilian Health Regulatory Agency (ANVISA), Brazil., Casas Levano M; General Directorate of Medicines Supplies and Drugs (DIGEMID), San Miguel, Peru., Chang W; National Medical Products Administration, China., Chew JY; Health Sciences Authority, Singapore., Chilufya MB; Zambia Medicines Regulatory Authority, Zambia., Chirachanakul P; Food and Drug Administration, Thailand., Cho HG; World Health Organization, Philippines., Cho YO; Butantan, Brazil., Choi KM; Ministry of Food and Drug Safety (MFDS), Republic of Korea., Chong S; Roche Singapore Technical Operations, Singapore., Chua HM; National Pharmaceutical Regulatory Agency, Malaysia., Farahani AV; Iran Food and Drug Administration, Iran., Gencoglu M; International Federation of Pharmaceutical Manufacturers Association, Switzerland., Ghobrial MRW; Central Administration for Pharmaceutical Affairs, Egypt., Guha P; Mylan Pharmaceuticals Private Limited, India., Gutierrez Lugo MT; Food & Drug Administration (FDA), USA., Ha SB; KOREA VACCINE CO., Republic of Korea., Habahbeh S; Jordan Food and Drug Administration, Jordan., Hamel H; Health Canada (HC), Canada., Hong Y; Samsung Bioepis, Republic of Korea., Iarutkin A; Federal Service for Surveillance in Healthcare (Roszdravnadzor), Russian Federation., Jang H; Samsung Biologics, Republic of Korea., Jayachandran R; Serum Institute India, India., Jivapaisarnpong T; Ministry of Public Health, Thailand., Kang HN; World Health Organization, Switzerland., Kim DY; GC Cell, Republic of Korea., Kim GH; MFDS, Republic of Korea., Kim Y; Hugel, Republic of Korea., Kwon HS; ILDONG Pharmaceutical Co., Ltd, Republic of Korea., Larsen J; Novo Nordisk A/S, Denmark., Lee AH; Eisai Korea Inc, Republic of Korea., Lee J; ALVOGEN KOREA, Republic of Korea., Medvedeva K; Biocad, Russian Federation., Munkombwe Z; Zambia Medicines Regulatory Authority, Zambia., Oh I; MFDS, Republic of Korea., Park J; LG Chem, Republic of Korea., Park J; EuBiologics Co., Ltd., Republic of Korea., Putri DE; National Agency of Drug and Food Control (NADFC), Indonesia., Rodgers J; Food and Drugs Authority, Ghana., Ryu S; ISU ABXIS Co., Ltd., Republic of Korea., Savkina M; The FSBI 'SCEEMP of the Ministry of Health of the Russian Federation, Russian Federation., Schreitmueller T; F. Hoffmann-La Roche, Ltd., Switzerland., Semeniuk O; Ministry of Health of Ukraine, Ukraine., Seo M; GC Cell, Republic of Korea., Shin YI; SK Bioscience, Republic of Korea., Shin J; World Health Organization, Philippines., Srivastava S; Central Drug Standards Control Organization (CDSCO), India., Song H; ILDONG Pharmaceutical Co., Ltd, Republic of Korea., Song S; Celltrion, Republic of Korea., Tavares Neto J; Brazilian Health Regulatory Agency (ANVISA), Brazil., Wadhwa M; National Institute for Biological Standards and Control, United Kingdom., Yamaguchi T; Pharmaceuticals and Medical Devices Agency (PMDA), Japan., Youn HD; GC Pharma, Republic of Korea., Yun M; Handok Inc, Republic of Korea.
Jazyk:	angličtina
Zdroj:	Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 May; Vol. 65, pp. 50-59. Date of Electronic Publication: 2020 Jan 17.
DOI:	10.1016/j.biologicals.2019.12.008
Abstrakt:	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. Competing Interests: Declaration of competing interest The authors have disclosed no potential conflicts of interests. (Copyright © 2019.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu Full Text from ScienceDirect