RSNN Expert Meeting Report - The route for ATMPs from bench to bedside

24 November 2021
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The RSNN expert meeting on the topic of ‘The route for Advanced Therapy Medicinal Products (ATMPs) from bench to bedside: the local hospital exemption procedure versus the EMA centralised authorisation’ was held on 10 March 2021. The full report of the meeting is now available.

ATMPs form a new group of drugs for somatic cell therapy, gene therapy and tissue engineering. Although ATMPs have only found their way into the clinic in recent years, this innovative group of drugs is considered to hold great promise for the development of future treatments. As a rule, a European marketing authorisation granted by the EMA is required before an ATMP treatment can be applied outside a research environment.

An exception may be made in certain situations, such as the for the ‘hospital exemption’ procedure. In the expert meeting the following questions were used to structure the discussion on the benefits and downsides of the local hospital exemption procedure versus the EMA centralised authorisation procedure:

  • What are the characteristics of these two procedures?
  • Are both routes easy to follow for all involved product developers (e.g., universities and the industry)?
  • Should both routes exist side by side or can a synergistic pathway be developed to reinforce the effect of both procedures? 

Twenty-seven experts with various affiliations were invited to discuss these and other questions pertaining to the current regulatory procedures for ATMPs. The expert meeting provided a clear overview of the existing regulatory pathways and associated requirements for providing patients with ATMP treatments. The research questions identified during this first exploratory ATMP expert meeting will be further discussed in a follow-up ATMP expert meeting.

The full report is now available for download below.

Expert Meeting report ATMPs (English, PDF file)
Expert Meeting verslag ATMPs (Nederlands, PDF file)