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The ICH E11A Guideline “Paediatric Extrapolation” reached Step 4 of the ICH Process on 21 August 2024.
The ICH is announcing that it will be releasing a Request for Information (RFI) expected in October to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force’s initial assessment for a secure standardised regulatory platform.
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.
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.
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.
The ICH Secretariat is pleased to announce the publication of the ICH Q12 “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management Introductory Video” following the publication of the ICH Q12 Module 8 in February 2024.