Ethical and regulatory environment

Ethical and regulatory environment

Eight central Ethics Review Committees (ERC) accredited by the Ministry of Health, out of which three are accredited by WHO, follow uniform guidelines that have been developed in line with ICH-GCP requirements and guidelines (www.cdda.com). All studies require approval from one of the accredited central ERCs. The NMRA of the Ministry of Health provides regulatory oversight.

In order to initiate a clinical trial in Sri Lanka, approval from the Sub-Committee on Clinical trials (SCOCT) of the National Medicine Regulatory Authority (NMRA), Ministry of Health (MOH), can be obtained once the clearance from one of the Ethics Review Committee (ERC) is obtained. The approval offered by SCOCT is valid for 5 years from the date of approval, and any extensions for the period of validity can be requested from SCOCT, no less than 60 days from the expiration of the validity of the initial approval.