The CVBF Scientific Director, Giovanni Migliaccio, also coordinating the specific working group for the TEDDY Network, took part in the Parties meeting organised by the Committee for Advanced Therapies (ATP) of the European Medicine Agency (EMA) the On 13 September 2018, in order to discuss and get input on the ATMP guidelines under development, the comparability for ATMPs and the Commission- EMA action plan for ATMPs.

According to the Regulation (EC) No 1394/2007 of the European Parliament and of the Council, ‘Advanced therapy medicinal product’ means any of the following medicinal products for human use:

  • a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC;
  • a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC;
  • a tissue engineered product containing or consisting of engineered cells or tissues and presented as having properties for regenerating, repairing or replacing human tissue.

The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field. The committee’s main responsibility is to prepare a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned.

At the request of EMA’s Executive Director or the European Commission, the CAT can also draw up an opinion on any scientific matter relating to ATMPs.

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). The procedure allows them to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP.

Further information is available here.

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By Published On: October 8th, 2018Categories: News0 Comments