The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three month consultation.
Stakeholders are invited to send their comments by 30 April 2018 using the template provided in the guideline
ATMPs offer new opportunities for the treatment of disease and injury based on innovative approaches and technologies. Because of this novelty, ATMPs may be associated with risks of a different nature to those generally encountered with more conventional medicines.
This is the first revision of the ATMP guideline and takes into consideration the experience gained with the authorisation of these medicines, as well as the experience 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. In addition, the revision gives methodological advice on the design of appropriate post-authorisation studies to follow up on the safety and efficacy of these medicines.
This revision is another step forward in the support of ATMP developers, further clarifying the requirements with regards to the post-authorisation safety and efficacy studies agreed at the time of marketing authorisation. It encourages developers of ATMPs to plan timely interactions with EMA to ensure an efficient development process.