February 2018: Portugal Regulatory Update

For performing clinical trials in Portugal, sponsors have to get authorization from the Competent Authority and ethical approval from the Ethics Committee (CEIC) plus approval from the National Data Protection Authority (CNPD – “Comissão Nacional de Proteção de Dados”).
The application to the REC, to the competent authority and to CNPD may be submitted in parallel, or in any order.
There is no procedural interaction between the competent authority and the national or local research ethics committee during the approval process. Nevertheless, all of them can request for it.

For obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Portugal, namely for clinical trials with medicines or studies with intervention of medical devices, regardless of whether this is for a single site or multiple sites, the sponsor have to request an opinion from the National Research Ethics Committee – CEIC – according to the guideline available on the website http://www.ceic.pt. For the other studies, the request has to be made to local health institution ethics committees.
The new law on the Clinical Research (Law 21/2014 of 16 April) creates a portal (RNEC) for the submission of all the requests for clinical studies. This portal is not yet operational.

Concerning the Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, which repeal Directive 2001/20/CE, it is not yet discussed or decided how will CEIC and the national competent authority work to achieve the single administrative decision for clinical trial authorisation.

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