Questions and answers A question-and-answer document is available for marketing authorisation holders on implementing the Article 5(3) CHMP opinion. It covers the following: Outcome of the Article 5(3) referral and its relation to lessons learned exercise from nitrosamines detected in sartansPrinciples, methodology and scope for nitrosamine management in human authorised productsGuidance for establishing and reporting acceptable intake limits derived from implemented approaches: carcinogenic [...]

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) is very pleased to announce the appointment of Géraldine Lissalde-Bonnet as Secretary General of the ICH Secretariat based in Geneva, Switzerland.

When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments"

The ICH Secretariat is pleased to announce the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5). The ICH Assembly approved this updated Q9(R1) Annex 1 on 30 October 2024.

Updated v1.27.0.0 Variation Human eAF is now available on the eAF website. The updated form includes the missing properties in the exported XML. The form will be available for use starting from 1 January 2025.

The ICH M15 draft Guideline on General Principles for Model-Informed Drug Development reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.

Updated v1.27.0.0 Variation Human eAF is now available on the eAF website. The form will be available for use starting from 1 January 2025.

Release of ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force Request for Information (RFI)

The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.

Meeting of a subgroup of CMDh with Interested Parties dedicated to the publication of outcomes of safety variations - 14 November 2024 MinutesPresentationsSafety Variation Example