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New guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors.
New issue released.
European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU
Out now.
Detailed released.
Full details have been published today of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible.
The ICH E6(R3) Introductory Training Presentation is now available on the ICH website
ICH E6(R3) (Principles and Annex 1), has reached Step 5 and will be effective from June 2025, and adopted on the 23rd July. ICH E6 (R2) remains in effect until 11 June 2025.
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 January 2025