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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:
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/docs/implementationplan-2007-12-11.pdf
The various linguistic versions of the regulation can be found here:
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev1.htm#reg1394_20077
Further information and respective guidance can be found on the EMEA website:
http://www.emea.europa.eu/htms/human/mes/advancedtherapies.htm
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:
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm
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.
Author:
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)
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