National Medicines Regulatory Authority Act — Lineage & Amendments
The National Medicines Regulatory Authority Act, No. 5 of 2015 was certified on 19 March 2015 and commenced on 1 July 2015. It established the NMRA as the successor to the Cosmetics, Devices and Drugs Authority (CDDA), implementing the Senaka Bibile National Drug Policy vision of ensuring safe, efficacious medicines at affordable prices. The Act is the most complex piece of health legislation in the Ministry's portfolio — 147 sections across 7 Chapters.
Act Overview
The Act creates NMRA as a self-funded body corporate with a 13-member board. It establishes dedicated regulatory divisions and evaluation committees for medicines, medical devices, and borderline products. It repeals the CDDA Act No. 27 of 1980.
Legend: 🟠 Principal Act | 🟢 NMRA (body corporate) | 🟣 Predecessor policy/institution | Gray = Repealed legislation
Source Documents
| Act / Document | Year | Source | Link |
|---|---|---|---|
| NMRA Act No. 5 of 2015 | 2015 | LawNet | HTML |
| NMRA Act No. 5 of 2015 | 2015 | Sri Lanka Law | HTML |
| NMRA Act No. 5 of 2015 (Full Text) | 2015 | CDN | |
| CDDA Act No. 27 of 1980 (repealed) | 1980 | Sri Lanka Law | |
| NMRA Annual Report 2023 | 2023 | Parliament |
The Act has not been amended since enactment. Its operational framework is updated through Gazette Notifications and Regulations under S.142, including major regulations for medicines, pricing, and clinical trials (2019) and pricing reforms (2025).
Governance Hierarchy
NMRA has a unique governance model — it is self-funded through regulatory fees (no Treasury allocation since 2017), yet subject to ministerial policy direction and parliamentary oversight.
Legend: 🔵 Minister | 🟢 NMRA Board | 🟠 CEO | 🟡 Regulatory Divisions | 🔵 Evaluation Committees | 🔴 Pricing | Light blue = Ex-officio/Appeals | Teal = Laboratory | 🟣 Advisory | Dashed = ex-officio link
Act Structure
The Act is organized into 7 Chapters with multiple Parts, totalling 147 sections.
Legend: 🟠 Act | 🟢 Ch.I Establishment | 🟣 Ch.II Advisory/Lab | 🔵 Ch.III Medicines | 🟡 Ch.IV Devices | 🔴 Ch.V Borderline | 🟤 Ch.VI Collective | Teal Ch.VII Misc