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

Publication date: Available online 17 January 2020Source: BiologicalsAuthor(s): Meenu Wadhwa, Hye-Na Kang, Teeranart Jivapaisarnpong, Aziza Ahmed, Lucia Rizka Andalucia, Carolina Damas Rocha Zarate Blades, Mary Casas Levano, Weihong Chang, Jing Yin Chew, Mumbi Bernice Chilufya, Parichard Chirachanakul, Heeyoun (Gloria) Cho, Yi O. Cho, Kyung Min Choi, Sannie Chong, Hui Ming Chua, Ali Vasheghani Farahani, Mumun Gencoglu, Mariam Raouf Wefky Ghobrial, Prasunkumar GuhaAbstractThe 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. G...
Source: Biologicals - Category: Biology Source Type: research