There are 3 levels of control for medical research in Portugal - National Council of Ethics for Life Sciences, Centres of Reflection and Health Ethics Committees. The National Council of Ethics for Life Sciences was created in 1990 and acts as a consultative body alongside the Council of Ministers. The Centres of Reflection consider bioethical issues and produce guidance on these issues for other bodies to consult

An Administrative Rule of the Minister of Health created another level of review with the Ethics Committee for Clinical Research (CEIC). Law 46/2004, which implements Directive 2001/20/EC requires that the CEIC issues a favourable opinion for clinical trials to proceed but in practice they can appoint a Health Ethic Committee to review the trial. The CEIC is responsible for monitoring Health Ethics Committees, receiving all applications for ethical review and is answerable to the Minister of Health. Decree Law 97/95 created Health Ethics Committees to review biomedical research and sets out their composition, operation and powers.

In the case of clinical trials, authorisation is required from the director and/or the administrative council of the hospital where the trial is to be carried out. Law 46/2004 states that authorisation from the National Institute of Pharmacy and Medicines (INFARMED) is also required for a trial to go ahead.