The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place in Incheon, Republic of Korea, in the week beginning 14 November 2022. It was chaired by Ms Lenita Lindström-Gommers (EC, Europe, ICH Assembly Chair) and Dr Gabriela Zenhäusern (Swissmedic, Switzerland, ICH Assembly Vice-Chair).
The ICH Assembly welcomed the Directorate of Pharmacy and Pharmaceuticals (DPM), Tunisia as a new ICH Observer, bringing ICH to a total of 20 Members and 36 Observers.
The Assembly endorsed the following Guideline by consensus (Step 4):
- ICH Q13 on “Continuous Manufacturing of Drug Substances and Drug Products”.
ICH Guideline E19 “A Selective Approach to Safety Data Collection in Specific Late-Stage Preapproval or Post-Approval Clinical Trials” was endorsed by Step 4 in September 2022.
An addendum to ICH S1B(R1) was adopted (Step 4) in August 2022, that was integrated with the original guideline and published as ICH S1B(R1) “Testing for Carcinogenicity of Pharmaceuticals”.
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 12 and 13 June 2023.
Further information can be found in the ICH press release: