It was published in the Official Gazette the Law number 21/2014, of 16 April, regarding clinical investigation.
The law foresees the rules for conducting clinical trials of medicinal products for human use and the regime of clinical investigation of medical devices.
The Law number 46/2004 of 24 August and some provisions of the Decree-Law number 145/ 2009 of 17 June are now repealed with the aim of "framing research made in these areas in a more comprehensive and harmonized way".
Although it is based on the provisions of the Law number 46/2014, it is now approved a general scheme for the appreciation of the Ethics Committee, for allocating the responsibility of the promoter, the investigator and the monitor of the clinical center to all areas of clinical research.
We highlight some of the main aspects covered by the new law:
The role of the Ethics Committee for Clinical Research and ethics committees for health is reinforced with the creation of the National Network of Ethics Committees for Health.
It also created the National Register of Clinical Trials, which is an electronic platform for the registration and disclosure of clinical trials. This platform aims to increase the access and knowledge to clinical trials in Portugal to the society and to the research community and health professionals.
Regarding the approval of clinical trials the proceedings are streamlined, namely, through the reduction of the period of review of clinical trials and studies with the use of medical devices.
In case of default the law foresees fines between 500.00 EUR to 50,000.00 EUR, applicable to individuals and between 5,000.00 EUR to 750,000.00 EUR, for companies.
The new Law of Clinical Investigation enters into force on 16 June 2014.