Advanced Therapy Medicinal Product (ATMP)

An advanced therapy medicinal product (ATMP) is a medicinal product based on genes, tissues or cells, offering ground-breaking treatment opportunities. ATMPs can be classified into three main types :

  • Gene therapy medicinal product
  • Somatic cell therapy medicinal product
  • Tissue engineered medicinal product

 

Some ATMPs are referred to as “combined ATMPs”: they contain one or more medical devices as an integral part of the medicine.

DRUG-DEV-CONSULTING

 

Regulatory product development at BlueReg

Authorisation Process
for Advanced Therapies

All advanced therapies are authorised centrally via the European Medicines Agency (EMA) and benefit from a single evaluation and authorisation procedure

 

The criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007. EMA’s Committee for Advanced Therapies (CAT) delivers scientific recommendations on ATMP classification after consultation with the European Commission within 60 days after receipt of the request.

 

Sponsors requiring clarification as to whether their product is classified as an ATMP can receive confirmation from the committee for advanced therapies (CAT) prior to submitting any application to the Agency. This advice is provided free of charge within 60 days of receipt of a valid request from an applicant.

 

BlueReg can guide you through this complex area to submit a classification application to CAT to determine if your product meets the requirements to be defined as an ATMP.

 

Our team can also support you through the entire application process from development, to registration and post-approval management.

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