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

Added in May 2024 27 May NEW - 28-29 May CMDh agenda 2 May NEW - Report from the meeting held on 23-25 April 2024 UPDATE - Request for MRP/RUP / Update assessment report NEW - Art 45 PAR on Alphanate (human von Willebrand factor, human coagulation factor VIII) NEW - Art 46 PAR on Riamet (artemether / [...]

Alphanate (human von Willebrand factor, human coagulation factor VIII)End of procedure: 23/07/2022Date of publication: 02/05/2024

Added in April 2024 3 April UPDATE - Q&A on Pharmacovigilance Legislation NEW - Procedural advice on Zero Day MR Procedures NEW - Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates NEW - Art. 46 PAR on Verorab (Rabies virus, inactivated) NEW - Art. 46 PAR on Triptorelin (Decapeptyl, Diphereline, [...]

Verorab (rabies virus, inactivated) End of procedure: 17/01/2024 Date of publication: 03/04/2024

Procedural advice on Zero Day MR Procedures (March 2024)