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The Sunset Clause and Renewals: Two Deadlines That Quietly End Authorisations
Most marketing authorisations are lost through inattention rather than refusal. Two provisions do the work: the renewal, which requires a positive act nine months before[…]
Transferring a Marketing Authorisation: A 30-Day Procedure with a Six-Month Tail
A marketing authorisation transfer looks like paperwork and behaves like a project. The regulatory step itself is fast — the European Medicines Agency must issue[…]
Importing Active Substances into the EU: Written Confirmations, Registration and the QP Declaration
Most finished medicines placed on the Greek and EU market rely on active substances manufactured outside the Union. The Falsified Medicines Directive closed that door[…]
PRIME, Accelerated Assessment and Conditional Approval: Building an Early Access Strategy
The EU has three distinct tools for getting a medicine that addresses an unmet medical need to patients sooner: PRIME support during development, accelerated assessment[…]
Joint Scientific Consultations: Aligning Regulators and HTA Before the Trial Starts
The Joint Clinical Assessment has changed what a European launch dossier has to prove. What it has not changed is when that proof has to[…]
Biosimilar Switching: What Regulators Settled and What You Still Have to Prove
The scientific argument about biosimilar switching was settled some years ago. In a joint statement issued in September 2022, EMA and the Heads of Medicines[…]
Electronic Product Information: The ePI Roadmap and How to Prepare
For as long as EU medicines have been regulated, the summary of product characteristics and package leaflet have been Word documents that become PDFs that[…]
The First Joint Clinical Assessment: What the Early JCA Pipeline Tells Us
The EU Health Technology Assessment Regulation stopped being theoretical in 2026. The Member State Coordination Group on HTA endorsed the first Joint Clinical Assessment report[…]
Outsourced Pharmacovigilance: Auditing the Partners Who Run Your Safety System
Very few marketing authorisation holders run every part of their pharmacovigilance system in-house. Case processing, literature screening, local safety contacts and database hosting are routinely[…]
The Pharma Package: From Political Agreement to Implementation Plan
After more than two years of negotiation, the EU’s pharmaceutical legislation reform has a settled text. The Council and the European Parliament reached political agreement[…]