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

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.