Further Progress in ICH's Global GMP Harmonization

The General Assembly of the ICH (International Council for Harmonization) took place in Montreal (Canada) in early November 2024, coinciding with the meetings of 11 working groups and a discussion group. This was followed by the meeting of the ICH Management Committee (MC).

The ICH continues to grow and was able to welcome the following countries resp. authorities as new ICH observers: Uzbekistan (CPPS), Peru (DIGEMID) and Thailand (Thai FDA). The ICH now has a total of 23 members and 38 observers.

Adoption of Guidelines and Revisions

The following ICH guidelines and revisions were adopted during the meeting:

• Guideline ICH M13A “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” with the corresponding questions and answers (Q&A) had already reached Step 4 of the ICH process before the meeting in Montreal. This guideline contains recommendations for conducting bioequivalence studies in both the development and marketing phases for immediate-release solid oral dosage forms (OSDs). The Q&A document is intended to provide additional guidance and assist in the design of bioequivalence studies
• Guideline ICH E11A “Pediatric Extrapolation” also reached Step 4 of the ICH process prior to the meeting. Guideline E11A provides a framework for the use of extrapolation to support the development of pediatric medicinal products.
  When adopted by consensus (Step 4) within the ICH, the guidelines are considered harmonized and represent the current state of the art in science and technology.

Progress in the development of ICH guidelines

• Draft Annex 2 of Guideline ICH E6(R3) “Good Clinical Practice (GCP)” reached Step 2a/b (public consultation) and was approved by the ICH General Assembly. This annex expands on the existing GCP principles and guidelines by providing specific considerations for clinical trials with decentralized and pragmatic elements as well as the use of real-world data (RWD).
• The draft guideline ICH M15 “General Principles for Model-Informed Drug Development (MIDD)” reached Step 2a/b and thus also the public consultation phase. This overarching guideline provides general recommendations for the planning, evaluation and documentation of evidence obtained from model-informed drug development (MIDD). The aim is to promote the strategic use of computer-based modeling and simulation methods that integrate non-clinical and clinical data in order to support drug development.

The next ICH General Assembly will take place on May 13 and 14, 2025 in Madrid, Spain.

More detailed information on the ICH Meeting can be found on the Swissmedic website.