You are currently viewing Advice on regulatory procedures for advanced therapy medicinal products that may be used during the development (I)

Advice on regulatory procedures for advanced therapy medicinal products that may be used during the development (I)

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

  2009-2015 2016 2017 2018 2019 2020 Total
Submitted 184 60 46 55 70 74 489
Adopted 150 87 49 43 67 87 483

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