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ATMPs classification procedure

There is a “Reflection paper on classification of advanced therapy medicinal products” (21 May 2015, EMA/CAT/600280/2010 rev.1) with the aim of:

1. Providing guidance on the ATMPs classification procedure. As a summary the following information is provided:
   • This procedure is conducted by the Committee for Advanced Therapies (CAT).
   • CAT delivers scientific recommendations on ATMP classification after consultation with EC within 60 days.
   • Voluntary and free of charge.
   • Useful tool for applicants to initiate dialogue on the product development with regulators.
   • Help developers to clarify the applicable regulatory framework.
   • Help developers to gain access to all relevant services and incentives offered by the EMA. 
2. Providing guidance on the interpretation of key concepts of the definition of gene therapy medicinal product, somatic cell therapy medicinal product, tissue engineered product, and combined advanced therapy medicinal product. This reflection paper includes:
   • 2 Decision Trees that can help applicants to classify their product.
   • Section 2.3 “Evolving and borderlines areas” clarifying borderline cases between ATMPs versus non- ATMPs as well as between the different product categories within the ATMP sphere:Advanced therapies versus transplants/transfusion
     • Classification of genetically modified bacteria as Gene therapy medicinal product 
     • Gene therapy medicinal product versus cell therapy medicinal product
     • Combined ATMPs versus non-combined ATMPs

In the last CAT monthly report (December 2020 meeting), there is a table that reflects the increasing of applicants following this AMTPs classification procedure – increased in last years.

ATMPs classification: scientific recommendation

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We hope you find this useful and of interest, and if you would like to discuss any of these updates with the team at REVIO, please get in touch.