The Ministry of Public Health and Social Assistance through the Ministerial Agreement 206-2021 approved the new Regulations on Clinical Trials in Humans, which came into force 30 October 2021.

All clinical trials carried out involving humans, must be authorised by the Research Ethics Committee and the Department of Regulation and Control of Pharmaceutical and Related Products.

The provisions of the new Regulations, amongst other things, establishes the requirements for the development of clinical trials and to ensure the basic ethical principles are followed, these being the respect, beneficence and justice of those involved in a study. In addition to the consideration of protection and consent of participating trial subjects, clinical trials must observe the ethical principles contained in the Declaration of Helsinki and the Rules of Good Clinical Trials Practice of the International Conference of Harmonisation accepted internationally.

With the new Regulations in place, it is expected that the competitiveness of the country in the global environment of clinical trials will improve.


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