The virtual Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place in Athens, Greece, in the week beginning 23 May 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 UK Medicines and Healthcare products Regulatory Agency (MHRA) as a new ICH member and Algeria's National Agency of Pharmaceutical Products (ANPP) as a new ICH observer, bringing the total number of members to 20 and observers to 35.
The Assembly endorsed the following Guidelines by consensus (Step 4):
- ICH M7(R2) Q&As on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”.
- ICH M8 eCTD “v4.0 Q&As and Specification Change Request Document v1.7” and “eCTD v4.0 Implementation Package v1.5
- ICH M10 Guideline on “Bioanalytical Method Validation and Study Sample Analysis”
The revised ICH E14/S7B Q&A Document “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” was endorsed by Step 4 in February 2022.
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 ICH Assembly also supported the creation of a new Guideline:
- Efficacy ICH Guideline on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials”
The next virtual meeting of the ICH Assembly will be held on 15 and 16 November 2022.
Further information can be found in the ICH press release: