Both documents are part of the joint action plan announced by EMA and the European Commission in October 2017 to bolster the development of advanced therapies.
The updated procedural advice document aims
The overall intention is to help developers of ATMPs – often small and medium-sized enterprises (SMEs) or academic spin-offs – to navigate the regulatory process in the EU. Additionally, the revised procedure allows for longer "clock-stops" during the evaluation of ATMPs to give sponsors more time to respond to questions raised by EMA or its scientific committees.
Alongside the updated advice document, EMA also released a new draft guideline on follow-up safety and efficacy requirements and risk management for ATMPs.
This draft guideline takes into consideration the experience gained with the authorisation of ATMPs 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 includes a risk management plan that should be followed after the time of approval.
EMA says that “The revised guideline 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.”
The draft guideline was adopted by the Committee for Advanced Therapies (CAT), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) and is open for public consultation until 30 April 2018.
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