Clinical gene therapy trials are conducted after the investigator has received permission as
stated in Gene Technology Act by the Ministry of Environment. The Gene Technology Act also establishes the Finnish Board for Gene Technology as a national authority and the Board functions as a competent authority. Separate from the notification process under the Board for Gene Technology (environmental aspects) a different review is conducted by the National Agency for Medicines concerning the medicinal aspects of the trial. Ethical opinion is given by a subcommittee on Medical Research Ethics. The National Agency for Medicines responsibilities are to maintain and promote the safety and safe use of medicinal products, medical devices and blood products. Its areas of focus are pediatric and biological medicinal products.
