Mauritius aspires to offer an attractive and favourable environment for carrying out clinical research on a large scale with high standards of public transparency and safety for clinical trials’ participants on the national and international front, stated the Minister of Health and Wellness, Dr Kailesh Kumar Singh Jagutpal, this morning, in Port Louis.
He was speaking at the launching of a consultative workshop on the Clinical Trial Framework in Mauritius with the aim to give a new impetus to clinical trials in Mauritius. The Senior Chief Executive of the Ministry of Health and Wellness, Mrs Anandi Rye Seewooruthun; the Chairperson of the Clinical Research Regulatory Council (CRRC), Dr Chan Sun; and other personalities, were present.
The Health Minister said that Mauritius is called upon to play a central role in the medical hub project which is currently being implemented. He underlined that the workshop will enable participants to discuss the means to develop an attractive platform for increased visibility of Mauritius as a Clinical Research Hub.
The Economic Development Board is a major stakeholder for clinical trials in Mauritius as it is actively involved in promoting clinical trials in Mauritius by attracting foreign investors in this sector, indicated the Minister.
He recalled that two regulations were promulgated in 2021 concerning the registration of Contract Research Organisations (CROs) and Medical Devices Trials. A total of 93 clinical trials have been carried out so far and, since 2011, no death has been reported as a result of clinical trials, he pointed out.
Minister Jagutpal further mentioned that the Pharmacovigilance Committee is entrusted with the responsibility to follow up on patients and monitor if ever any adverse effect is being observed.
He indicated that in order to carry out clinical trials on Mauritian patients, the CROs have to rigorously follow the guidelines and criteria set in the Clinical Trials Act which are inspired from the European Medicine Agency.
“At the end of the workshop, participants will come up with a comprehensive framework to sustain this sector but also to expedite matters so that the CRO applying for a license to carry out research or clinical trials obtains its license in time whilst ensuring that the company is following all the guidelines and criteria imposed,” stated the Minister.
For her part, Dr Chan Sun said that the workshop will provide a platform to discuss mechanisms for compliance verification and clinical auditing as well as make proposals for training of investigators. It will also enable the actors of the industry to identify priority actions to develop the trial in line with EU guidelines, she highlighted. In Mauritius, she indicated that the CRRC, EC and Pharmacovigilance Committee have been created under the Clinical Trials Act 2011 to offer an attractive and conducive legal environment for carrying out clinical research in Mauritius.
In line with Government’s vision to promote Mauritius as a clinical trial destination, the CRRC is working on the development of its website for increased visibility of Mauritius as clinical trial venue, she indicated.
She also announced that as from 31 January 2023, all applications for new clinical trials must be submitted through the EU online platform, that is, the Clinical Trial Information System.