Committee for Advanced Therapies (CAT)

Advanced-therapy medicines may offer new treatments for many rare diseases. The Committee for Advanced Therapies (CAT) at the European Medicines Agency assesses their quality, safety and efficacy.

Advanced-therapy medicines may offer new treatments for many rare diseases. The Committee for Advanced Therapies (CAT) at the European Medicines Agency assesses their quality, safety and efficacy.

The CAT was established in 2009 in accordance with the Regulation (EC) 1934/2007, which came into force on 30 December 2008. Its main responsibility is to prepare a draft opinion on each Advanced Therapy Medicinal Product (ATMP) application submitted to the European Medicines Agency (EMA).The CAT draft opinion is then forwarded to the Committee for Medicinal Products for Human Use (CHMP), which adopts a final opinion on the granting, variation, suspension or revocation of a marketing authorisation for the medicine concerned.

Other responsibilities of the CAT include providing recommendations on the classification of advanced-therapy medicinesreviewing data on the manufacture and testing of medicines developed by small companiescontributing towards an environment that encourages the development of advanced-therapy medicines; and providing scientific advice and expertise for any initiatives related to the development of innovative medicines and therapies, at the request of the European Commission.

See CAT members for the list of current members

Composition of the Committee

  • The CAT is composed of:

    • five members or co-opted members of the Committee for Medicinal Products for Human Use (CHMP), with their alternates. These members are appointed by the CHMP itself;
    • one member and one alternate appointed by each European Union (EU) Member State that is not represented by the members and alternates appointed by the CHMP;
    • two members and two alternates appointed by the European Commission to represent clinicians;
    • two members and two alternates appointed by the European Commission to represent patient associations.

Mariëtte Driessens (European Genetic Alliances Network) is the full member representing patients’ organisations.

Michele Lipucci di Paola

Michele Lipucci di Paola, PhD, is the EURORDIS nominated volunteer currently sitting as an alternate member at the CAT representing patients’ organisations.
Current mandate: July 2013 – 2016
Thalassaemia Association Italy

 

 

 

 

Paula SalmikangasPaula Salmikangas, MD, Chairman of the CAT 

Current mandate: 2013-2016 
Finnish Medicines Agency

 

 

 

 

 

 

Page created: 02/02/2010
Page last updated: 22/11/2016
 
 
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