This topic was endorsed by the ICH Assembly in June 2021.

Further to the ICH Management Committee’s endorsement of the Q6(R1) Concept Paper in July 2024, the Q6(R1) Guideline aims to update and modernise simultaneously the ICH Q6A and Q6B guidelines by promoting consistency between ICH Q6A and Q6B and establish general principles in setting specifications for all product modalities; aligning with other relevant ICH guidelines and current approaches; and revising the scope of the guideline to incorporate contemporary modalities. In addition, the Q6(R1) EWG aims to develop complementary training material with relevant examples/case studies.