RNEC_SlideShow
Electronic portal for submission and management of Clinical Studies
Recognizing the huge relevance that human clinical research has for medical and economic outcomes, Law n.er 21/2014, of April 16, brought a new regulatory framework on this matter.
One of the news introduced was the creation of a National Registry for Clinical Studies (RNEC) to serve as a tool for registry and publication of all clinical studies undergoing in Portugal and that involve human beings, namely, clinical trials and other studies of clinical nature involving investigational products, medicines, medical devices and cosmetic products, allowing for a better interaction with all the stakeholders.
RNEC's functioning rules are published in Governmental Decree n.er 65/2015, of March 5.
RNEC's objectives are laid down in its regulation and include the future creation of an information databank of clinical studies, to facilitate the transmission and monitoring of information (privileging electronic processes to do so) for authorization and notification procedures presented to competent authorities and ethics committees, as well as to increase access and knowledge to the research community, healthcare professionals and society in general to all clinical studies undergoing in Portugal. This is a very challenging project for Portugal, but we are sure that it will be accomplished with great success, for the benefit of professionals and researchers, as well as the public in general.
RNEC allows the electronic submission of the following clinical studies:
- Clinical investigations of medical devices (as an alternative pathway only, until the European database on medical devices ¿ EUDAMED ¿ is fully operational);
- Clinical studies with the use of cosmetic products;
- Post-Authorization efficacy studies (PAES) without intervention;
- Post-Authorization Safety Studies (PASS) without intervention;
CLINICAL TRIALS SEARCH
RNEC provides a search area, which allows:
- The search of Clinical Trials authorized under Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, and of Clinical Trials that were authorized under Directive 2001/20/EC, and have transitioned to the Clinical Trials Information System (CTIS), under the same Regulation | option "Clinical Trials Search";
- The search of Clinical Trials authorized under Directive 2001/20/EC, and which were completed by 31 January 2025 | option "Clinical Trial Search ended until 31/01/2025 (Directive)".
| INFARMED, I.P. - Information Center of Medicines and Health Products (CIMI) Telephone: (+351) 217987373 e Linha do Medicamento: 800222444 (gratuita) | Supported browsers: Microsoft Internet Explorer 8.x and above |
