European Compliance Academy (ECA) Initiates New Working Group

GMP News
30 April 2008

European Compliance Academy (ECA) Initiates New Working Group

The Regulation on advanced therapy medicinal products (Regulation (EC) No 1394/2007) has been published on 10 November 2007 and will become effective on 1 January 2009. On 13 December 2007 DG Enterprise and Industry published its priorities for the implementation of this Regulation. The implementation plan has been developed and agreed with EMEA.

The Regulation EC1394/2007 lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy products. Central to the operation of this Regulation is the Committee for Advanced Therapies (CAT) established as part of the EMEA. The joint Commission and EMEA document is available here: 

The various linguistic versions of the regulation can be found here:

Further information and respective guidance can be found on the EMEA website:

On 9 January 2008 the Commission published a public call for expressions of interest relating to the appointment by the European Commission of members and alternates representing clinicians and patients' associations at the Committee for Advanced Therapies of the European Medicines Agency (EMEA). The public call is available in all EU official languages:

In light of these developments, interest has been expressed to set up an Interest Group focusing on Advanced Therapies (Tissue Engineering, Cell Therapy and Gene Therapy). In case this initiative is well received, it will be established to support you through providing the opportunity for exchanging experience, ideas and insights.

If you are interested in setting up and contributing to this new Interest Group we would appreciate your message by using the ECA contact form.

Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)

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