Regulatory Services in Spain

The Spanish Agency for Medicines and Medical Devices, or Agencia Española de Medicamentos y Productors Sanitarios (AEMPS), of the Ministry of Health has exclusive authority to approve, license, and monitor safety, efficacy, quality, and compliance of pharmaceutical and medicinal products across Spain. Additionally, it regulates and authorizes clinical trials in accordance with the European Medicines Agency (EMA). The AEMPS provides guidelines on registration, pharmacovigilance, clinical trials, availability, formulations, packaging and labelling for medicinal products intended for human use. These are consistently reviewed and updated. Additionally, the AEMPS is also authorized to disclose non-public information to the U.S. FDA for pre-marketing and post-marketing activities of AEMPS-regulated drugs. Hence, all products for human and/or veterinary use are evaluated, authorized, monitored, and supervised while maintaining compliance with regional guidelines. Manufacturers seeking successful market authorizations for their products in Spain are advised to ensure they are informed on all the guidelines and requirements set by the AEMPS.

As a leading global contender, DDReg’s regulatory services in Spain provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings and market authorizations.