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 development and implementation steps of ICH guidelines (data source: reference [4] content team drawing of Wuxi apptec) are the guidelines in step 3: E8 (R1) and E19 E8 (R1), which is the first revision of the guidelines for overall considerations in 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 ▲ ICH guidelines (data source: reference [5], [6], [7], [8], content team drawing of Wuxi apptec) are expected to reach the guidelines of step 4: at the ICH conference held in Singapore, we expect that the four guidelines will reach 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 The current guiding principles and new guiding principles, current ICH guiding principles and new guiding principles are involved in 14 topics and work areas under discussion See the table below for related topics Data source: reference [1], new issues and revised ICH of content team of Wuxi apptec have 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 Data source: reference [1], content team drawing reference: [1] Michael mezher ICH updates: what to expect through 2020 Nov 5 2019 Retrieved Nov 11, 2019 from https://
[2] FDA Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting Oct 10, 2018 Retrieved Nov 2, 2019 from https://
[3] ICH Meeting of ICH Working Groups Singapore, 16 – 20 November 2019 Retrieved Nov 3, 2019 from https://admin.ich.org/sites/default/files/2019-08/ICH39Singapore_ListOfWGmeeting_Nov2019_FINAL_2019_0822.pdf
[4] ICH Formal ICH Procedure Retrieved Nov 3, 2019 from https://
[5] ICH Quality Guidelines Retrieved Nov 6, 2019 from https://
[6] ICH Safety Guidelines Retrieved Nov 6, 2019 from https://
[7] ICH Efficacy Guidelines Retrieved Nov 6, 2019 from https://
[8] ICH Multidisciplinary Guidelines Retrieved Nov 6, 2019 from https:// original title: viewpoint | ICH guiding principles: what's new in 2020?