The Spanish Agency of Medicinal Products and Medical Devices informs about the submission of the application for clinical trial authorisation Nº. 1000 via Voluntary Harmonisation Procedure. AEMPS encourages sponsors to continue using this procedure that facilitates clinical trial authorization until the new clinical trial Regulation’s effective application date, foreseen for October 2018.
The objective of the National Action Plan is to develop a series of necessary strategic lines and actions to reduce the risk of selection and dissemination of antibiotic resistance and subsequently, reduce its consequences for the health of animals and humans, thus conserving the existing therapeutic arsenal in a sustainable manner. This Plan fulfills the requirements of the European Commission.
The National Action Plan on Antimicrobial Resistance (PRAN) is led and coordinated by the Spanish Agency of Medicines and Medical Devices (AEMPS), together with the active collaboration of six Ministries (Health, Agriculture, Economy, Internal Affairs, Defense and Education), all the Spanish autonomous communities and more than 190 professionals from the fields of both human and animal health, belonging to a total of 60 scientific societies, collegiate organizations, universities and professional associations.
The Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices) publishes the second version of the document “How are Medicines and Medical Devices regulated in Spain”. As a public service, the mission of the AEMPS is to give guarantees to the general public on the quality, safety, efficacy and accurate information on medicines and medical devices, in the widest remit, from research to end use, to protect and promote health in both human beings and animals. Its vision is to strengthen the reference health authority for citizens and healthcare professionals with regard to guarantees of quality, safety, efficacy, information and accessibility of medicines and medical devices.
The Charter of services of the “Agencia Española de Medicamentos y Productos Sanitarios” (the Spanish Agency of Medicines and Medical Devices) for citizens and users, provides information about the entrusted services, about the rights they have in relation to these services, and about the quality commitments regarding the improvement of public services they render, responding to citizens' and users' demands. This Charter of services is based on the Royal Decree 951/2005 of 29th July, establishing the general framework for quality improvement in the General State Administration.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has launched the Spanish Clinical Studies Registry (REec). The Registry, available on the following website: https://reec.aemps.es, provides information to patients and healthcare professionals about clinical researches approved in Spain, in order to report on ongoing researches on a given disease, syndrome or a related treatment with human medicines.