Streamline EU Approval with Strong Pharmacovigilance Documentation

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.

In the autumn edition of International Clinical Trials, UBC provides practical advice for avoiding roadblocks related to safety documentation. The article delves into:

  • Interrelated documentation consistency
  • Readiness for application and a complete pharmacovigilance system master file (PSMF)
  • Risk management plan considerations, including the impact of missing information
  • The need for additional risk minimisation activities to ensure safe and effective use of the drug

Click here to read the full article.

Understanding and avoiding potential pitfalls in the application process can save valuable time and speed approval. UBC’s team of pharmacovigilance experts can guide your product through the EU application process. Contact us to learn more.

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