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Gene Therapy Legislation in Romania

The National Medicines Agency (NMA) carries on the tradition in ensuring medicinal products quality. It is the Mission of the National Medicines Agency (NMA) to contribute to the protection and promotion of public health through: evaluating at the highest scientific competence level of the authorization documentation for the purpose of bringing on the market high quality, safe and effective medicinal products; supervising the safety of the medicinal products in the therapeutical circuit through the activities of inspection and pharmacovigilance; ensuring for the patients and the healthcare personnel the access to useful and correct information regarding the medicinal products authorized to be brought on the market in Romania; ensuring the administrative effectiveness and efficiency of the organization (NMA) and the transparency of the practices and procedures used. There has been so far no experience with clinical gene therapy trials in Romania.