Streamline EU Approval with Strong Pharmacovigilance Documentation

The centralised procedure, which came into operation in 1995, allows applicants to pursue a marketing authorisation that is valid throughout the EU. The European Medicines Agency (EMA) can take up to 210 days to review these new product applications and the agency has an additional 15 days to submit its opinion to the Commission.

Manufacturers waiting for the EMA’s opinion may feel like time is standing still. Ensuring safety and regulatory documentation is properly prepared and consistent helps keep the review process moving.


The Evolving Post-Marketing World: Key Takeaways from ISPOR 16th Annual European Congress

ISPOR 16th Annual European Congress, held November 2-6 in Dublin, was a great success, providing the opportunity for thought-provoking presentations as well as valuable networking and information sharing.

Industry thought leaders participated in a panel that explored patient-reported outcomes and how best to incorporate them in EMA and FDA safety mandates. Additionally, our UBC experts presented a number of abstracts throughout the conferences.

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