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ICH semi-annual meeting held in Prague in 2023
To guide global standardization in drug development, leading practices in standardized clinical trials were discussed at the ICH semi-annual meeting held in Prague in 2023.
In response to the growing need for global regulatory standards in drug development, the ICH Management Committee, along with the ICH MedDRA Management Committee and the ICH Technical Working Group, convenes every six months with representatives from around the world. The aim is to develop new global guidelines for drug development and review or revise existing ICH guidelines. Expert Working Groups (EWGs), managed by the ICH Secretariat, also convene during these semi-annual meetings to formulate or revise new or proposed ICH technical documents, as needed by the groups. This collaborative effort forms an integral part of the International Drug Regulatory Program (IPRP), guiding the formulation and implementation of drug regulatory policies in various countries. During each ICH annual conference, global drug regulatory authorities, especially the core member states of ICH drug administration, send delegations to participate. As a core drug regulatory country, China NMPA actively participated in the conference, making significant contributions to the ICH Management Committee meetings and EWG exchanges, earning positive reception from both the ICH Management Committee and participants.
The ICH Congress for the second half of 2023 is scheduled to take place from October 28 to November 1 at the Congress Center in Prague, Czech Republic. The meeting included discussions on various ICH Guidance technical focus groups, such as Q1, Q2, Q3, Q9(R1), Q14, M1, M11, M13, M15, M4Q(R2), E2B(R3), E6(R3) Annex 2, E11A, E20, E21, Annex 2, E11A, E20, E21, Annex 3, Annex 2. Notably, meetings were held to discuss the development and revision of relevant technical guidance documents. Among these, E20 (Adaptive clinical trials) and E21 (Recruitment of pregnancy and lactation personnel for clinical trials), which are related to clinical trial practice, were approved by the ICH Management Committee and are currently in the drafting stage of conceptual documents. The ICH E6 (R3) Annex 2 Technical Guidance Task Group, chaired by FDA Khair ElZarrad, saw participation from FDA, EMA, PMDA, China NMPA, and several other national pharmaceutical regulatory authorities and industry technical associations (such as Brazil, Germany, Canada, Singapore, Turkey, WHO, IFPMA, etc.). They discussed and exchanged Annex 2 technical documents as members of ICH E6(R3) EWG. Between ICH semi-annual live meetings, EWG members worldwide in the Annex 2 thematic Group met online weekly to communicate and discuss the content development of ICH E6(R3) Annex 2. Dr. Chuan Liu, Chief Scientific Officer of Colleneca, represented the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) as a member of the Technical experts at this ICH site meeting, contributing to the development of the EWG technical document in ICH E6(R3) Annex 2 (Other Considerations for Intervention in Clinical Trials).
Since the release of ICH E6(R2) in 2016, clinical trial practice has witnessed new design concepts and technological innovations. The ICH E6(R3) Annex1 Technical Guidance (GCP, Exposure draft), published in May, has been revised to align with the trend towards technical interoperability throughout the lifecycle of clinical trial data. The Annex 2 technical guidance document, building on Annex 1, will address how GCP principles can be applied to new trial design and data source management considerations, including decentralized clinical trial elements, practical trial elements differing from traditional clinical practice, and real-world data source management. Once finalized, Annex 2, as an important supplement to Annex 1, will become a global guidance document for ICH E6, guiding clinical trial normative practice and detailing data monitoring requirements. This will contribute to improving the efficiency and operability of clinical trial operations, ensuring the safety of subjects and the reliability of trial results.
