A number of defects have been reported in the release v.1.19 of the eAFs. The EMA is working hard to fix these issues as soon as possible and a hotfix release will be deployed as soon as possible. Meanwhile if you are experiencing issues with any of the electronic application forms v.1.19 as published on [...]
A webinar on the eAFs (initial, variation, renewal) for Human and Veterinary procedures will be held on 01 December 2015 from 13.00 to 14.30 UK time. This webinar is dedicated to Industry. This session will not demonstrate how to fill in the forms but will rather provide information where to find relevant documents and will [...]
Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (October 2024)
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.
Concerned Member State's Comments on Lead Member State's Preliminary assessment report (April 2025) [Track version]
PSUR recorded webinar training sessions and updated presentation slides for Marketing Authorisation Holders and National Competent Authorities users are available here.
The ICH M4E(R2) Guideline reaches Step 2b of the ICH Process in August 2015 and now enters the consultation period (Step 3).
• Version 01.03 of the PSUR Repository is now available for both MAHs and NCAs. This new release provides change requests further enhancing the system and fixes defects identified during the pilot phase. The updated system release notes and MAH and NCA user guides on the PSUR respository page.
CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System (May 2023) [Track version]
The Integrated Addendum of the ICH E6 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3). The E6 Integrated Addendum has been developed to complement the harmonised ICH E6 Guideline which was finalised in May 1996.