WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27–28 April 2017

Wadhwa, Meenu; Kang, Hye‐Na; Hamel, Hugo; Jivapaisarnpong, Teeranart; Allam, M. F.; Alway, Beverley; Aprea, Patricia; Blades, C.; Chirachanakul, Parichard; Chong, Sannie Siaw Foong; Dahlan, Juliati; Doh, Hea Jeong; Griffiths, Elwyn; Jeong, Jayoung; Jung, Jaewoon; Jung, Yu-Jin; Kim, Byoungguk; Kim, Dae‐Cheol; Meyer, Heidi; Munkombwe, Zuma; Oh, IlUng; Ramanan, Sundar; Rodgers, Jacqui; Schiestl, Martin; Schreitmueller, Thomas; Seng, Tzer Jing; Seo, Kwang-Seok; Seo, Kyung Won; Shin, Jin-Ho; Sohn, Yeowon; Song, Suwon; Spitzer, E.; Suh, Soo Jhi; Волкова, Р. А.; Wei, Wei; Song-mei, Xie; Yamaguchi, Teruhide

doi:10.1016/j.biologicals.2017.12.002

Cited by 2 publications

(1 citation statement)

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“…In response to requests from its Member States [3,4], WHO developed new guidelines on procedures and data requirement for changes to approved biotherapeutic products (hereafter referred to as 'the Guidelines') which were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2017 and published in WHO Technical Report Series No. 1011, Annex 3 [1].…”

Section: Introductionmentioning

confidence: 99%

Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements

Hamel

Kang

2019

Biologicals

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Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls on biotherapeutic products and such changes often need to be implemented after the product has been approved. WHO guidelines on procedures and data requirement for changes to approved biotherapeutic products were issued in 2017 to provide guidance to national regulatory authorities and manufacturers on the regulation of changes to already licensed biotherapeutic products in order to assure their continued quality, safety and efficacy, as well as continuity of supply and access. The case studies in this article were prepared to be used for WHO implementation workshops. Using these case studies, an interactive discussion was carried out among the workshop participants, and this article reflects the outcomes of case study exercise and lessons learnt from the 1st implementation workshop on the guidelines held on 25–26 June 2019, Seoul, Korea.

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Section: Introductionmentioning

confidence: 99%