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The ICH Reflection Paper which the ICH Assembly decided to progress at its recent meeting in Vancouver, Canada on 13 June 2023, is now available for public consultation until 30 September 2023 on the ICH website.
Today the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.
Today the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13 June 2023, in Vancouver, Canada in parallel of meetings of 14 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The ICH E6(R3) draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process in May 2023 and subsequently entered the consultation period.
The ICH M7(R2) Guideline on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has reached Step 4 of the ICH Process in April 2023.
The ICH E6(R3) draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.
The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum have reached Step 4 of the ICH Process on 3 April 2023.