New section on the website dedicated to Spain's role as a Reference Member State (RMS)
Last week, the Spanish Agency of Medicines and Medical Devices (AEMPS) launched a new section on its website related to applications for Spain to act as a Reference Member State (RMS) in European decentralised and mutual recognition/repeat use procedures.
The section provides information of interest to the industry on applications and facilitates their processing.
CLINICAL TRIALS | European Clinical Trials Regulation
Two years after the entry into force of the European Clinical Trials Regulation, all clinical trials in the EU are now governed by this Regulation.
Centralisation and reduction of approval times are still challenges to be addressed, but the Spanish Agency for Medicines and Health Products (AEMPS) is implementing measures to resolve them, such as the fast-track procedure for innovative trials.
Directive on Medicinal Products for Human Use
Last week, the Presidency of the European Union announced that it aims to conclude an agreement with the European Parliament before the end of this year to move forward with the new Directive on Medicinal Products for Human Use.