What will be the new developments in the ICH Guidelines for 2020?

The biennial ICH Conference was held in Singapore from November 16-20In early November, at a public consultation session between the FDA and Health Canada in Ottawa, officials from two drug regulatory agencies presented guidelines at different stages of the development processThese include two guidelines for recent arrival of ICH process step 3, and four guidelines for the ich process step 4, which are expected to arrive shortlythe first revision of the guidelines for the development and implementation of the ICH guidelines (data source: Resources: References, 4, Drug Mingconde Content Team Mapping)guidelines in Step 3: E8 (R1) and E19E8 (R1) guidelines, the first revision of the guidelines for overall considerations in ICH E8 clinical trialsThis revision introduces quality from design principles and quality factors that are critical to the guidelinesIn October, ICH held a public meeting on E8 (R1) to solicit suggestions and comments from organizations that are not yet represented in ich on the draft guidelines until it is finalized in May next yearThe E8 Expert Working Group will need to review the recommendations, comments gathered from public meetings and make the necessary changesThe Step 4 file is available by June 2020the ICH E19 Guidelines for The Optimization of Safe Data Acquisition, the aim of E19 is to "reduce the collection of non-critical adverse events or other security data with knowledge of the safety characteristics of the drug(safety profile) by explaining the circumstances under which selective security data collection methods are used." The outcome of the E19 consultation, which will be discussed at the ICH conference in Singapore this month, is expected to be adopted in June 2020the guidelines for ich (data sources: Resources, 5, 6, 7, and 8, Pharmaceutical Kant Content Team Mapping)guidelines for expected arrival in step 4: E9 (R1), M9, Q12, S5 (R3)the ICH Conference in Singapore, and are expected to reach step 4, including E9 (R1), M9, Q12 and S5 (R3) Appendix)E9 (R1) appendix provides a framework for defining the estimated objectives (estimand) applicable to clinical trials and conducting sensitivity analysisOn the basis of the draft, the relevant parties revised the final version of the appendix to include treatment as one of the attributes to be covered when considering the target of estimationsince the ICH Amsterdam meeting in early June this year, relevant parties have initiated the revision of the ich M9 Bioequivalence Research Exemption Sequivalence Based on the Biopharmaceutical Classification System (BCS), which will be included in Appendix 3, which will include a question-and-answer session on the clarification of various aspects of the guiding principles at the same time, , the revision of the ICH Q12 Guiding Principles, Technical and Regulatory Considerations for Drug Life Cycle Management, remains concerned about the implementation of some of the guiding principles in some areas , following the update of Annexes 1 and 2 covering animal studies and other studies, it is expected that the relevant parties will sign a revision of ich S5(R3) Reproductive Toxicity of Human Medicines the existing guidelines and new guidelines the existing ICH guidelines and new guidelines, a total of 14 topics and areas of work are under discussion See the table below for related topics data sources: Resources, New issues and revisions the Drug Ming-Conde Content Team Mapping ICH recently began focusing on six new topics, all of which are in the early stages of development (see table below) It is expected that informal working groups on each topic will finalize their concept papers and plans at a meeting in Singapore later this month Data Source: Resources, Pharmaceutical Conde Content Team Mapping Resources: ICH Update: What to Expect Through 2020 Nov 5 2019 Retrieved Nov 11, 2019 from https:// Health Canada and United States Food and Drug Administration Regional Consultation on the International Council for The Department of The International Council for The Technical Requirements for Pharmaceuticals for Human Use; Public Meeting Oct 10, 2018 Retrieved Nov 2, 2019 from https:// Meeting of ICH Working Group 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 Formal ICH Procedure Retrieved Nov 3, 2019 from https:// Quality Guidelines Retrieved Nov 6, 2019 from https:// Safety Guidelines Retrieved Nov 6, 2019 from https:// Efficacy Guidelines Retrieved Nov 6, 2019 from https:// Monon Guidelines Retrieved Nov 6, 2019 https:// Original title: Viewpoints ICH Guidelines: What will be the new developments in 2020?