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International Council for Harmonisation (ICH) update

Date
May 21, 2025
Category

ICH Regulations

Description

The ICH Assembly met in-person on 13 & 14 May 2025, in Madrid, Spain in parallel with meetings of 11 Working Groups. At this meeting three new observers were added:

  • Paraguay (DINAVISA),
  • Kuwait (MOH) and
  • El Salvador (SRS)

Bringing ICH to a total of 23 members and 41 observers

At the Madrid meeting the Assembly adopted four new topics for harmonisation:

  • “Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines” – a new ICH Efficacy Guideline that proposes a systematic approach to using RWE in regulatory decision making.
  • “Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs” – a new ICH Multidisciplinary Guideline to address factors to consider in determining the utility of comparative efficacy studies (CES) in biosimilar development programs.
  • “Natural History Studies and Registry Data to Advance Rare Disease Drug Development” – a new ICH Efficacy Guideline aims to provide high-level, harmonised principles for designing and conducting natural history studies and registries in rare diseases.
  • “Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process (Annex to ICH Q5E)” – A new Annex to the ICH Multidisciplinary Guideline ICH Q5E is proposed to address the unique development and regulatory challenges of ATMPs, such as gene and cell therapies.

The ICH E6(R3) Revised Guideline on “Good Clinical Practice” was adopted by the ICH Assembly, at Step 4 of the ICH process, in January 2025 prior the Madrid meeting.

The following guidelines were endorsed at step 2 a/b at or prior to the Madrid:

  • ICH M4Q(R2) draft “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality”
  • ICH E21 draft “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials”
  • ICH Q1 draft on "Stability Testing of Drug Substances and Drug Products” (April 2025)
  • ICH M13B draft on "Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver" (March 2025)
  • ICH M11 “Clinical Electronic Structured Harmonised Protocol (CESHARP)” (March 2025)

The next ICH Assembly meeting is planned on 18 and 19 November 2025 in Singapore.

Read more: ICH Official web site : ICH