The ICH M13A Guideline and associated Q&As on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms” reached Step 4 of the ICH Process on 23 July 2024.

Added in August 2024 2 August UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers

2024 January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

Added in September 2024 16 September NEW - 17-18 September CMDh agenda

Added in July 2024 2 July NEW - 28-29 May 2024 CMDh minutes

Member: Jascha Johann Hörnisch Alternate: Ursula Ladstaedter  BASG/AGES Traisengasse 5 1200 Wien, Austria

The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.

Added in June 2024 5 June NEW - 23-25 April 2024 CMDh minutes NEW - Report from the meeting held on 28-29 May 2024 UPDATE - The Worksharing Procedure for the Assessment of Active Substance Master File (ASMF) UPDATE - Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, [...]

The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.

The ICH M14 draft Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” has reached Step 2 of the ICH process on 21 May 2024.