Medicines regulator sets clinical trials rules
The National Medicine Regulatory (NMRA) Authority has taken steps to regulate clinical trials on medicines, devices and borderline products listed in its registry.
NMRA said that the step has been warranted because of the lack of controls on clinical trials on pharmaceuticals products.
Pharmaceutical medicines, devices and borderline products earlier came under the Cosmetics Devices and Drug Act, but with the products coming under a new regulatory authority, the NMRA, the laws on clinical trials were not gazetted.
The new regulations under the National Medicine Regulatory Authority Act No 5 of 2015 will give legal hold on all persons and centres that carry out clinical trials on all medicines, devices and borderline products. At present the law is weak and cannot hold person/ institutions conducting clinical trials, responsible for results inferred in clinical tests.
According to the gazette notice No 2145/2 of October 14, 2019 persons and institutions wishing to do clinical studies on registered medicines, devices and borderline products should be suitably qualified principal investigators, co-ordinator principal investigator, or a national co-ordinator registered with the Sri Lanka Medical Council, a recognised health care institution, or a university in Sri Lanka.
Also they need to have the approval of the NMRA and the ethics review committee (ERC) to perform clinical trials on registered products outside the conditions of such registration that may change indications and clinical use, the target population, routes of administration and dosage regimen.
Approval is granted after a clinical trial evaluation committee reviews the trials including assessment, its scientific merit, relevance, risk involved and expected benefits of each trial protocol.
The NMRA’s clinical trials regulatory division approves around 12 clinical trials a year. In Sri Lanka most of trials are done by university academics who carry out tests on the safety and efficacy of the pharmaceutical products in the market.
Pharmaceutical medicines, devices and borderline products earlier came under the Cosmetics Devices and Drug Act, but with the products coming under a new regulatory authority, the NMRA, the laws on clinical trials were not gazetted.