Pharmacovigilance for advanced therapies

All relevant legislation and guidelines regarding pharmacovigilance in the European Union (EU) are applicable to advanced therapy medicinal products (ATMPs).

For more information on the general pharmacovigilance framework, see:

ATMP-specific guidelines

In February 2018, EMA released a draft revised guideline on safety and efficacy follow up and risk management of ATMPs for a three-month public consultation:

The guideline focuses on the unique characteristics of ATMPs, in line with Article 14 (4) of Regulation (EC) No 1394/2007.

This revision takes into consideration the experience gained with the authorisation of these medicines and with scientific advice and protocol assistance. It also provides advice on:

  • 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.


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