EMA guidance

EUROPEAN-WIDE AGENCIES

European Medicines Agency (EMA)

The EMEA was established by Council Regulation (EEC) No 2309/93 of 22 July 1993 and London was chosen as its seat. The agency is in charge of coordinating scientific resources existing in Member States with a view to evaluating and supervising medicinal products for both human and veterinary use. On the basis of the Agency’s opinion, the European Commission authorizes the marketing of new medicinal products and arbitrates between Member States for other medicinal products in case of disagreement. Information about regulation of gene and cell therapy can be searched on the EMEA Web Site. Currently, you can find on the EMEA webpage under "Human Medicines" the section "Advanced Therapies" with information relevant for gene and cell therapy.

The common Website for the medicines authorities in the European Union (Heads of Medicines Agencies) is http://www.hma.eu/.

NATIONAL MEDICAL AGENCIES

Under http://www.hma.eu/ you will find a list with links to the EU Member State Medicines Agencies. You can find those specific to your country by following the link "Choose your country".

Australia Therapeutic Goods Administration (TGA)
Belgium Pharmacetical Inspectorate
Canada Health Protection Branch, Health Canada
Denmark Laegemiddelsstyrelsen
Finland National Agency for Medicines
France Agence du Médicament
Germany BFAM/PEI (Paul-Ehrlich-Institut)
Greece National Drug Organization
Iceland Lyfjastofnun
Ireland Irish Medicines Board
Italy Ministry oh Health
Japan National Institute of Health Sciences
Netherlands Medicines Evaluation Board
Norway Statens legemiddelkontroll
Portugal National Institute of Pharmacy and Medicines
Spain Spanish Agency for Medical Products
Sweden Lakemedelsverket