Labelling requirements for metered dose inhalers containing fluorinated greenhouse gases (September 2024)

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.

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.