- According to the National Medicines Regulatory Authority Act No. 05 of 2015 the National Medicines Regulatory Authority shall be responsible for the regulation and control of all aspects pertaining to clinical trials.
- National Medicines (Clinical Trials) Regulations No 2145/2 of 14 of October 2019 to control and regulate matters pertaining to authorization and conduct of clinical trials in Sri Lanka including
- Authorization to conduct Clinical Trials
- Conduct of Clinical Trials
- Consenting of Study Participants
- Responsibilities of Investigator
- Responsibilities of Sponsor to conduct a clinical trial in Sri Lanka