Pharmacovigilance for advanced therapies
For more information on the general pharmacovigilance framework, see:
ATMP-specific guidelines (updated)
- early detection of risks during development and provides a framework for the effective mitigation of their consequences for patients;
- the design of appropriate post-authorisation studies to follow up on the safety and efficacy of these medicines.
It encourages developers of ATMPs to plan timely interactions with EMA to ensure an efficient development process.
The revision is part of the joint action plan of the European Commission and EMA to streamline procedures and better address the specific requirements of ATMP developers. For more information, see Advanced therapies: overview.