Advanced therapies: post-authorisation

  • Email
  • Help

The European Medicines Agency's scientific and regulatory guidance on post-authorisation activities for human medicines marketed in the European Union apply to advanced therapy medicinal products (ATMPs). In addition, EMA has published specific guidance on pharmacovigilance for ATMPs.

For more information on post-authorisation activities, see Post-authorisation.

In this section


How helpful is this page?

Average rating:

 Based on 46 ratings

Add your rating:

See all ratings
9 ratings
9 ratings
9 ratings
10 ratings
9 ratings

Tell us more

Related content