Inauguration of the EMEA’s Committee for Advanced Therapies |
Published 16/01/2009 |
The European Medicines Agency (EMEA) is pleased to announce the formal creation of its sixth scientific committee, the Committee for Advanced Therapies (CAT), which met for the first time on 15 January 2009. Created following the entry into force of new European Union legislation on the regulation of advanced-therapy medicinal products, the CAT will play a central role in the assessment of innovative medicines based on gene therapy, somatic cell therapy and tissue engineering – advanced medical technologies that promise to deliver groundbreaking new treatment options for patients suffering from serious diseases or injuries. The CAT’s main role will be to prepare a draft opinion on each advanced-therapy medicinal product submitted to the EMEA for evaluation as part of a marketing-authorisation application, prior to the adoption of a final opinion by the Committee for Medicinal Products for Human Use (CHMP), which retains overall responsibility for scientific evaluation of human medicines at the EMEA. |
For further information, see: |
CVMP celebrates its 150th plenary meeting |
Published 14/01/2009 |
The Committee for Medicinal Products for Veterinary Use (CVMP), the European Medicines Agency’s body responsible for the scientific evaluation of veterinary medicines, this week celebrates its 150th meeting. Since its inaugural meeting in January 1995, the CVMP has contributed in many ways towards improved animal health and public safety in the European Union, notably through its involvement in: The photograph shows CVMP Chair Gérard Moulin (centre), Vice-chair Anja Holm and EMEA Executive Director Thomas Lönngren at a small ceremony held to mark the 150th meeting of the CVMP. |
Click here for further information about the CVMP |
Update on pilot programme to rationalise international inspection activities published |
Published 09/01/2009 |
As a follow-up to EMEA's proposal published in July 2008 outlining plans to coordinate inspection activities between a group of participating regulators, a revised paper providing an update on the status of activities has been prepared by the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The publication of the paper, which also includes key performance indicators and rules of engagement, marks the official beginning of an 18-month pilot programme for sharing inspections-related information between the participating regulators. These activities form part of international efforts to rationalise the use of global good-manufacturing-practice (GMP) inspection resources by sharing information and avoiding the unnecessary duplication of inspection work. This initiative contributes to the objectives announced at the Transatlantic Economic Council in May 2008. |
For further details see Update on a pilot project to rationalise international GMP inspection activities |
Latest Press Releases | See Press Office for archived press releases |
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16/01/09 | PDCO | Press Release from the 7-9 January meeting |
16/01/09 | CVMP | Press Release from the January Meeting |
16/01/09 | EMEA | Press release on inaugural meeting of the CAT See also, Questions and answers on the regulation of advanced-therapy products |
16/01/09 | EMEA | Press Release - Priority access for children during Myozyme supply shortage |
08/01/09 | COMP | Monthly Report from the January meeting |
07/01/09 | CHMP | Monthly Report from the December meeting Corr. |
19/12/08 | EMEA | Press Release - Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec) |
17/12/08 | MB | Press Release EMEA Management Board adopts work programme for a busy year ahead and agrees to move towards greater transparency of its meetings |
See Press Office for archived press releases |