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.
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