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Gene Therapy Legislation in Sweden

The Swedish Medical Products Agency (MPA), part of the Ministry of Health and Social Affairs, is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and sale of drugs and other medicinal products. The Swedish Working Environment Authority (SWEA) is the competent authority for contained use of GMOs in Sweden. In the field of clinical gene therapy trials there is close collaboration with the MPA. Applicants are expected to submit a single application to the MPA for authorization. The evaluation of the recombinant DNA aspects runs separate from the clinical trial demand. During this evaluation a network of agencies and experts will be involved. The Swedish Gene Technology Advisory Board (Gentekniknämnden) and Swedish Environmental Protection Agency, which are the central advisory bodies for all applications of GMOs, may also provide a review. Finally, a single authorization, combining the clinical trial and the GMO aspects is provided by the MPA.

(Last reviewed by the Competent Authority: 20 September 2010)