The government of Mauritius presented the clinical trials act, adopted by the national assembly on the 19th April 2011, to supply the legal frame to drive clinical trials in the country. This act aimed to harmonize the laws, regulations and administrative provisions relating to the implementation of good clinical practices in driving clinical trials of drugs for human use in Mauritius, in accordance with ICH/GCP (International Council for Harmonisation / Good Clinical Practice) and with related European legislations.The mauritian independent qualified institutions, which ensures compliance with these standards, are : 

(1) the Clinical Research Regulatory Council (CRRC); 

(2) the Ethics Committee (EC); and 

(3) the Pharmacovigilance Committee (PC). 

The CRRC depends on the Ministry of Health; this council studies the relevance of the project, ensures the safety of the participants and finally gives its consent or not to the realization of the study. The EC gives an opinion on the ethical aspect of the study : it is the guarantor of well-being and protection of the interests of persons participating in a study.

Click on the link to download CLINICAL TRIALS ACT 2011 : (CTA)

The European General Data Protection Regulation (GDPR) took effect on May 25, 2018. In view of the major changes brought by the GDPR, the data protection laws in Mauritius were amended to be in line with the GDPR, by virtue of the Data Protection Act 2017 (DPA), effective on the 15th January 2018.