During the development of new products, it is essential to evaluate and identify possible risks, associated with the clinical use relating to quality, safety and efficacy of an ATMP, according to Annex I, part IV of Directive 2001/83/EC. Therefore the original "Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products" was adopted in 2008.
The experiences in the last 10 years relating to authorisation of ATMPs, the evaluated risks and to measures for risk minimisation, a revision was indispensable. So the new guideline is supposed to provide guidance for the Safety and Efficacy (S&E) follow-up and risk management for advanced therapy medicinal products (ATMPs) according to 51 Regulation (EC) No 1394/2007 and to help with the methodology in order to design post-authorisation S&E follow-up studies.
The Guideline includes the following chapters:
- Legal basis and relevant guidelines
- Pharmacovigilance system
- Safety and efficacy concerns for ATMP
- Pharmacovigilance activities
- Risk minimisation measures
- Efficacy and safety follow-up
- Management and reporting of adverse reactions and PSURs
- Compliance monitoring
When such a safety and efficacy follow-up and risk management results in new and important information, documents like the Pharmacovigilance System Master File (PSMF) and the Risk Management Plan (RMP) are directly impacted and must be updated.
More and detailed information about can be found directly in the "Draft Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products"