Table 3 Competent authorities for clinical trials on typical investigational medicinal products in ten EU countries.
Country | Competent authorities for typical investigational medicinal products |
|---|---|
Austria | The "Bundesamt für Sicherheit im Gesundheitswesen" (BASG, Federal Office for Health Safety) [42], supported by the Austrian Medicines Agency, AGES PharmMed [43]. |
Denmark | The Danish Medicines Agency [44]. |
France | Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) [45]. |
Germany | The Federal Institute for Drugs and Medical Devices (BfArM) [46], and the investigator has also to submit the protocol to the local competent authority. |
Hungary | The National Institute of Pharmacy (NIP) [47]. |
Ireland | The Irish Medicines Board (IMB) [48]. |
Italy | All clinical trials have to be declared on the database of the Agenzia Italiana del Farmaco (AIFA) (Osservatorio Nazionale Sulla Sperimetazione Clinical Dei Medicinali; National Monitoring Centre for Clinical Trials) [49]. For phase I clinical trials, the competent authority is the Istituto Superiore della Sanita (ISS) [50]. For phase II, III and IV clinical trials, the competent authority is the director of the Public Health Facility [51]. |
Spain | The Spanish Agency for Medicines and Medical Devices (AEMPS) [52]. Performance of clinical trial on medicinal products not authorised in the EU and containing any active substance not included in any authorised medicinal product in Spain requires an additional application for a 'product under clinical research qualification' (PEI). |
Sweden | The Medical Products Agency (MPA) [53]. |
The UK | The Medicines and Healthcare Products Regulatory Agency (MHRA) [54]. |