With the approval of the decree, and now published in Official Gazette dated December 24, the Royal Decree that regulates the different procedures for authorization of trials become more agile the bureaucratic process that was taking place until Now, without undermining the necessary guarantees for it. It also will facilitate transnational European research aspects harmonizing with European legislation, something that in recent years has been the focus of criticism because of the difficulty posed to national and international studies.
The new regulation provides, first, common procedures for the authorization of clinical trials across Europe urging that Member States cooperate in the assessment by a single and common position, but leaves out of this cooperation on the other aspects of inherently national character to require an assessment by each Member State. Furthermore, in order to promote clinical research in the European Union, it sets deadlines highly appraised evaluation maintains the concept of tacit authorization and does not establish minimum periods for approval.
The new European regulation also introduces some changes in the definitions They are of great importance, especially but not only, for research promoted by academic researchers. And introduces the concept of "clinical trial of low intervention" on the caller to adopt less stringent standards in areas such as monitoring the content of the master file or traceability, without compromising the safety of individuals participating in them
National development of legislation are important, first integrating Ethics Committees of Clinical Research and secondly the Spanish Register of trials, a broader perspective that also allow the recording of observational studies with drugs that are classified by the Spanish Agency for Medicines and Health Products. Furthermore, the creation of this record was taken into account the public interest which arises in the revised text of the law on guarantees and rational use of medicines and health products, for clinical drug trials extending voluntarily, all prospective clinical studies outside the field of medicinal products.