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:
Press release on inaugural meeting of the CAT
Overview of the role, composition and membership of the CAT
Questions and answers on the regulation of advanced-therapy products

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 authorisation of 84 new veterinary medicines;
• the establishment of maximum residue limits for over 700 substances;
• the development of guidance on tackling antimicrobial resistance.

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
Click here for information about the EMEA’s work in the veterinary-medicines sector

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
and Rules of engagement.