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.

Following the adoption of the Q2(R2) and Q14 Guidelines, a Step 4 Introductory Training Presentation has been developed by the Q2(R2)/Q14 Expert Working Group.

Member: Tea Linhola Alternate: Paulina Ikäheimo   Finnish Medicines Agency P.O. Box 55 FI-00034 FIMEA

Template for Applicant's responses to the questions raised by RMS and CMSs   Applicant's response template (September 2023)

Member: vacant Alternate: Neringa Kalinauskaite State Medicines Control Agency Žirmūnų str.139A 09120 Vilnius LITHUANIA