National medicines regulatory authority of Italy, established in 2003 and based in Rome under the Ministry of Health and the Ministry of Economy and Finance. Authorises and registers medicines for human use, negotiates prices and reimbursement with the national health service, inspects manufacturers and distributors for good manufacturing and distribution practice, authorises and oversees clinical trials, runs pharmacovigilance and the national medicines usage reports, and represents Italy at the European Medicines Agency.
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