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.
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.