June 2018: Portugal Regulatory Update

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.

CEIC – National Ethics Committee for Clinical Research

National Ethics Committee for Clinical Research

National Ethics Committee for Clinical Research (CEIC) is the REC responsible for assessing Clinical trials with investigational medicinal products applications and also studies with intervention of medical devices. Nevertheless, CEIC may delegate this assessment to a local health research ethics committee The requirements for these ethics committees to be competent to do such evaluation have to be defined, by law, by the National Ethics Committee (CEIC).

Members of the National Ethics Committee are appointed by the Health Minister and the law has established that CEIC is independent and multidisciplinary and that all the members must declare publicly their conflicts of interest (all this information is available in the CEIC webpage).

The National Ethics Committee for Clinical Research has 35 members: a president, a vice-president, seven executive committee members and 28 other members. Members have recognized qualifications on medical sciences (medical doctors, pharmacists, nurses, psychologists), ethics, theology, epidemiology and pharmacoepidemiology, sociology and philosophy. CEIC members include also lawyers, mathematicians, laymen and a patient’s representative.
By law, and whenever necessary CEIC may ask for independent external expertise.

There are no formal training requirements for RECs members Nevertheless there are in each plenary meeting a training session in different areas. New members are trained and helped with the old ones whenever they have to evaluate clinical trials proposals.

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