From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD. The European Medicines Agency (EMA) strongly recommends using the electronic submission channels (eSubmission [...]
Non Clinical / Clinical AR for Generics - MRP & DCP ( December 2017)
Recommendation for implementation of Commission Decisions or CMDh agreements following Union referral procedures where the marketing authorisation is maintained or varied (October 2025) [Track version]
Portugal has now joined the Common Repository to receive Centralised Procedure submissions.
A comprehensive report of the last ICH meeting that was held in Minneapolis, MN, USA on 4-5 June 2014 is now available on the ICH website under the SC Reports page.
During summer 2014, the ICH Steering Committee approved the establishment of four new ICH Efficacy Expert Working Groups...
Geneva, August 15, 2014 – The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is conducting a Call for Tender for the MedDRA Maintenance and Support Services Organization (MSSO) contract.
Summary PAR - Generics (March 2018)
The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 4 of the ICH Process in November 2013 and now enters the implementation period (Step 5).
Summary PAR for non-generics (June 2014)