What new developments will be made in the ICH guidelines in 2020?

The technical guidelines formulated and issued by ICH are recognized as the technical requirements for drug registration representing the international advanced level In the coming 2020, what new progress will be made in the formulation and implementation of ICH guidelines? The biennial ICH conference was held in Singapore from November 16 to 20 In early November this year, at the FDA and Health Canada public consultation held in Ottawa, officials from the two drug regulatory agencies introduced the guiding principles at different stages of the development process These include two guidelines for step 3 of the recently arrived ICH process and four guidelines that are expected to arrive in step 4 of the ICH process in the near future The guiding principle of E8 (R1) is the first revision of the guiding principle of overall considerations for ICH E8 clinical trials In this revision, quality is introduced from design principles and quality factors that are essential to the guiding principles In October this year, ICH held a public meeting on E8 (R1) Before it was finalized in May next year, the suggestions and opinions on the draft guiding principles from organizations that have not yet been represented in ICH were collected The E8 expert working group will need to review the suggestions and opinions collected from the public meeting and make necessary modifications Strive to release step 4 documents by June 2020 For the guideline of ICH E19 "optimization of safety data collection", the purpose of E19 is to reduce the collection of non serious adverse events or other safety data by explaining the circumstances in which selective safety data collection methods are used "when the safety profile of drugs is known" The results of the E19 consultation will be discussed at the ICH conference in Singapore this month, and step 4 is expected to be adopted in June 2020 At the ICH conference in Singapore, it is expected that the four guiding principles will meet step 4, including the annexes of E9 (R1), M9, Q12 and S5 (R3) The annex to E9 (R1) provides a framework for defining the applicable estimated objectives for clinical trials and for conducting sensitivity analysis On the basis of the draft, the relevant parties revised the final version of the appendix, taking treatment as one of the attributes that should be covered when considering the estimation target Since the ICH Amsterdam conference held at the beginning of June this year, relevant parties have started to revise the guideline of ICH M9 "exemption from bioequivalence research based on biopharmaceutical classification system (BCS)"; the guideline will be included in Appendix 3, and the specific content is the Q & A for clarification of multiple aspects of the guideline At the same time, relevant parties began to revise the guideline of ICH Q12 "technical and regulatory considerations for drug life cycle management", but they are still concerned about the implementation of some of the guidelines in some regions It is expected that amendments to ICH S5 (R3), reproductive toxicity of human drugs, will be signed after updating Annexes 1 and 2 covering animal studies and other studies In terms of current ICH guidelines and new guidelines, 14 topics and work areas are under discussion See the table below for related topics ICH recently started to focus on six new issues, all of which are in the early stage of development (see the table below) It is expected that informal working groups on each theme will finalize their concept papers and plans at a meeting to be held in Singapore later this month Original title: viewpoint ICH guidelines: what's new in 2020? A kind of