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.

对于制造工艺的持续改进和维持生物治疗产品最先进的控制而言，变革至关重要，并且此类变革通常需要在产品获得批准后实施。世卫组织于 2017 年发布了关于变更已批准生物治疗产品的程序和数据要求的指南，旨在为国家监管机构和制造商提供对已许可生物治疗产品变更的监管指导，以确保其持续的质量、安全性和有效性。作为供应和获取的连续性。本文中的案例研究准备用于世卫组织实施研讨会。利用这些案例研究，研讨会参与者进行了互动讨论，本文反映了案例研究的成果以及从 2019 年 6 月 25 日至 26 日在韩国首尔举行的第一届指南实施研讨会中汲取的经验教训。