The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place in Vancouver, Canada, on 12 & 13 June 2023. It was chaired by Ms Lenita Lindström-Gommers (EC, Europe, ICH Assembly Chair) and Dr Gabriela Zenhäusern (Swissmedic, Switzerland, ICH Assembly Vice-Chair). In parallel, meetings of 14 Working Groups took place, preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH Assembly welcomed the EDA, Egypt as the first African Regulatory Authority to join ICH as a Member, along with NAFDAC, Nigeria as a new ICH Observer. This brings ICH to a total of 21 Members and 36 Observers.
The Assembly was informed of the formation of a new ICH “Cell and Gene Therapies” Discussion Group (CGTDG) which will serve as a technical discussion forum for issues related to ICH harmonisation efforts in the field of CGT products.
The Assembly adopted three new topics for harmonisation at the Vancouver meeting, with the starting timeframe to be determined in a subsequent step:
- “General Considerations for Patient Preference Studies”
- “Nonclinical Safety Studies for Oligonucleotide-based Therapeutics”
- “Bioequivalence for Modified-Release Products”
Adoption of Guidelines
The Revised ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and accompanying Addendum entitled “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” were adopted by Step 4 in April 2023.
ICH Guideline S12 on “Nonclinical Biodistribution Considerations for Gene Therapy Products” was adopted (Step 4) in March 2023.
Revised ICH Q9(R1) Guideline on “Quality Risk Management” was adopted by Step 4 in January 2023.
Updated ICH E2B(R3) Questions and Answers (Version 2.4) for the ICH E2B(R3) Guideline on “Electronic Transmission of Individual Case Safety Reports (ICSRs)” were adopted (Step 4) in January 2023.
When Guidelines are endorsed by consensus within the ICH organisation (Step 4), they are regarded as harmonised and therefore as “documents that reflect the current state of science and technology” (see Swissmedic Journal 05/2006, p. 504).
The next meeting of the ICH Assembly will be held on 31 October and 1 November 2023 in Prague, the Czech Republic.
Further information can be found in the ICH press release: