In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Regulation of changes to approved biotherapeutic products is a key in ensuring that products of consistent quality, safety and efficacy are distributed after they receive authorization or licensure. Participants agreed that the guidelines would contribute to assuring the continued quality, safety and efficacy throughout the life-cycle of biotherapeutics as well as continuity in supply and access. In the meeting, participants further requested WHO should assist national regulatory authorities in improving technical expertise in the evaluation of biotherapeutics and their post-approval changes by organizing implementation workshops and developing case studies and e-training modules on various technical topics. At its meeting in October 2017, the WHO Expert Committee on Biological Standardization formally adopted the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products.
Keywords: Biotherapeutic product; Post-approval changes; Regulation; World Health Organization.
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