Pharmacovigilance for advanced therapies

  • Email
  • Help

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 phamacovigilance guidelines

EMA has published detailed guidance focusing on the unique characteristics of ATMPs, In line with Article 14 (4) of Regulation (EC) No 1394/2007.The guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products.

This guideline describes a framework of regulatory requirements applicable to all ATMPs. Specific provisions for gene-therapy, cell-therapy and tissue-engineered products continue to be included in product type-specific guidelines.

How helpful is this page?

Average rating:

 Based on 12 ratings

Add your rating:

See all ratings
7 ratings
1 ratings
0 ratings
1 ratings
3 ratings
    

Tell us more

Related content

Related EU legislation

Related documents