The Spanish Agency for Medicines and Healthcare Products (AEMPS) has published the correction of errors of version 10 of the document of instructions for conducting clinical trials in Spain, which came out on December 17, 2018.
The Royal Decree 1090/2015, of December 4, which regulates clinical trials with drugs, the Research Ethics Committees with drugs (CEIm) and the Spanish Registry of Clinical Studies, introduces substantial changes in national legislation with the aim of making possible the application of the Regulation of the European Union (EU) number 536/2014 of the European Parliament and of the Council, of April 16, 2014 and develop those aspects that it leaves to the development of the national legislation.
In the present document of instructions of the AEMPS for the realization of clinical essays in Spain is provided, in a format of questions and answers, information on the practical aspects that entails the application of the new royal decree highlighting the changes with respect to the previous norm.
This report aims to cover those aspects that Royal Decree 1090/2015, of December 4, leaves to the development of instructions by the AEMPS, as well as any other that requires clarification. This document is complementary to the ‘Memorandum of collaboration’ between this Agency and the CEIm referred to in article 18 of Royal Decree 1090/2015, of December 4, which will also be public.
In Distefar we echo the new document on instructions for clinical trials in Spain.