Malaysia launches Phase 1 Clinical Trial Guidelines
The Malaysian clinical research field marked an important milestone with the launching of Malaysian Phase I Clinical Trial Guidelines during the Clinical Research Malaysia’s (CRM) Industry Dialogue 2017.
In a statement, CRM said it was part of a much bigger initiative of the Phase I Realisation Project (P1RP) which aimed at building a complete and comprehensive early phase clinical research ecosystem in the country.
It said the writing committee had been tasked by the Ministry of Health (MOH) to develop a standard reference for the conduct of first-in-human (FIH) trials in the country.
The shift of industry-sponsored clinical trials to regions like Asia has prompted the Malaysian government to target clinical research, particularly clinical trials, as one of its main economic growth factors. The Malaysian Phase I Clinical Trial Guideline writing committee was therefore set up under the directive of the Malaysian Ministry of Health to develop a standard reference for the conduct of first-in-human (FIH) trials in the country.
The committee members included experts in the field of clinical trials from the Ministry of Health, Ministry of Higher Education, industry experts and regulatory officers from National Pharmaceutical Regulatory Agency. In addition, international experts on clinical trials were also invited as Subject Matter Experts and to be part of the guideline writing committee.
The feedback from the industry players were also gathered during the development of this guideline.
Category: Community, Education
