AEMPS

The Spanish Agency for Medicines and Medical Devices is a governmental agency belonging to the Ministry of Health, Social Services and Equality. This regulatory agency is responsible for ensuring the quality, safety, efficacy and accurate information of medicines and health products from its research to use.

In this regards, a wide range of activities are developed by the Agency, including the support to the research and development of medicinal products (innovation office, scientific advice activities); the authorization of clinical trials and approval of clinical investigations with medical devices, the evaluation and authorization of medicines for human and veterinary use; monitoring of the safety and effectiveness of marketed medicines, etc. The Agency is also responsible for the Inspection, authorization and registration of manufacturers as well as responsible for the certification, control and surveillance of medical devices and cosmetics.

The AEMPS is actively involved in EU forums related to the above mentioned competences on human and veterinary medicinal products, medical devices and cosmetics. There is a permanent representation of the Spanish agency in each of the EMA Committees and working parties as well as the EC Committees and groups. Transparency and confidentiality agreements are implemented according to the EU standards.