POLICIES & ADVOCACY / 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 super-vising medicinal products for both human and veterinary use. On the basis of the Agency’s opinion, the European Commis-sion authorizes the marketing of new medicinal products and arbitrates between Member States for other medicinal prod-ucts 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