Advanced Therapy Medicinal Product (ATMP) classification

Did you know, that pharmaceutical companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is considered an advanced therapy medicinal product (ATMP)?

In doing so, they are allowed to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007.

In order to submit an application for ATMP classification, applicants have to complete a:

  • pre-submission request form
  • ATMP-classification request form and briefing information

and return both forms to the EMA.

Applies to your company? Ivowen are here to assist you.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton