Mock-ups, Specimens and Samples for variations and renewals
Mock-ups, Specimens and Samples for variations (May 2024) [Track version]
Mock-ups, Specimens and Samples for new applications
Mock-ups, Specimens and Samples for new applications (December 2020) [Track version]
Template – Preliminary Renewal Assessment Report (September 2012)
Template - Preliminary Renewal Assessment Report (February 2025) [Track version]
Pharmacovigilance Legislation
Pharmacovigilance Legislation [Track version] (December 2020, correction March 2024)
Practical guidance on the…
Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP (May 2022) [Track version]
The eCTD v4.0 Q&A v1.4 reaches Step 4 of the ICH process
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.
Reflection Paper on Patient-Focused Drug Development for public consultation
ICH is conducting a public consultation on its ICH Reflection Paper on Patient-Focused Drug Development (PFDD), which was endorsed by the Assembly in November 2020.
Press release ICH Assembly virtual meeting, November 2020
The International Council for Harmonisation (ICH) met virtually on 18 November in place of face-to-face meetings that were to take place in Athens, Greece, and preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
Templates Variation Assessment Report
Type II variation Preliminary Variation Assessment Report (November 2020) Type II variation Final Variation Assessment Report (February 2025) [Track version]
Member: Priscilla…
Member: Priscilla Schoondermark Medicines Evaluation Board P.O Box 8275 3503 Utrecht RG The Netherlands