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Advice on ‘end-of-year’ submission dates for type I variations in 2026
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings no later than 20 November 2026. This deadline allows EMA to acknowledge the validity of...
EMA UPDATE : COMPLIANCE with EU GMP Annex 22 and Artificial Intelligence Standards
On october 2 , the EMA published its multi-stakeholder workshop report on Annex 22 ("Artificial Intelligence" ) EMA aims to achieve the following objectives via this workshop: Collect expert insights on responsible AI requirements, risk identification and...
FDA GUIDANCE DOCUMENT – E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification;
FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for implementing the E2B(R3) data standards. The main document is the E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation...
The Council of the European Union has formally adopted the Pharmaceutical Package
The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching reform of the EU’s pharmaceutical...
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