Conducting clinical trials in Sri Lanka – Regulatory Landscape
Sri Lanka features a robust regulatory framework administrated by the National Medicines regulatory agency (NMRA) in compliance with GCP standards set by the International Council for Harmonization (ICH) and the US Food and Drug Administration (FDA) . Several steps have been taken by NMRA to strengthen the regulatory processes overseeing clinical research in Sri Lanka. This includes the release of NMRA Act No.5 of 2015 and Clinical trials regulations. Both of which are aligned with ICH GCP guidelines. Within NMRA there is a sub-committee known as Clinical Trials Evaluation Committee (CTEC) that is responsible for reviewing, approving & regulating clinical trials in Sri Lanka. NMRA has recognized nine central Ethics Review Committees (ERCs) to review and approve clinical trials and all of these recognized ERCs have standard Operating procedures that are conforming to the requirements of the WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants and are having a membership in the Federation of Ethics Review Committees of Sri Lanka (FERCSL). All nine ERCs are recognized by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER).