National Medicines Regulatory Authority

Sri Lanka

Welcome to the official website of the National Medicine Regulatory Authority of Sri Lanka. We are dedicated to ensuring the safety and efficacy of medicines for the people of Sri Lanka.

Providing Quality Medicine Regulation in Sri Lanka

The National Medicine Regulatory Authority of Sri Lanka is committed to ensuring the safety, efficacy, and quality of medicines in the country. We strive to protect public health by regulating the manufacturing, importation, distribution, and sale of medicines.

Functions of the NMRA

Regulatory

NMRA regulates medicines, medical devices, borderline products imported to and manufactured in Sri Lanka. We also regulate pharmacies. Clinical trials conducted in Sri Lanka are also regulated by us.

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Laboratory

National Medicines Quality Assuarance of the NMRA is responsible for the analyzing of the quality of any medicine, medical device or borderline product forwarded by the Authority. It functions as an additional approved analyst when the circumstance so requires.

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Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

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Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

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Latest Announcements

Regulatory Updates

Public Day for Local Agents - pricing Division

November 19, 2024
NMRA Updates

Notice to All Market Authorization Holders

November 12, 2024
Regulatory Updates

Consignment Clearance under Borderline category

November 8, 2024
Regulatory Updates

Email Address to access the Google sheet on NMRA website

November 6, 2024
Regulatory Updates

Registration of Cefuroxime injection 1000 mg

November 4, 2024
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Regulatory Updates

Public Day for Local Agents - pricing Division

November 19, 2024

The pricing Division will hold a Public Day for local agents to discuss matters related to pending application on Friday, 22nd October 2024,at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

NMRA Updates

Notice to All Market Authorization Holders

November 12, 2024

Due to Parliament Election 2024, the accepting counter and the Accounts division counter will be closed on 14th of November 2024. The Administrative division counter will be opened only for very urgent work.

Chief Executive Officer

NMRA

Regulatory Updates

Consignment Clearance under Borderline category

November 8, 2024

Consignment clearance approval for the products that may come under the category of borderline will not be granted with the effect from 30th November 2024.

(Date: 08 November 2024)

Regulatory Updates

Email Address to access the Google sheet on NMRA website

November 6, 2024

To all MAH of Medicines,

In our ongoing efforts to ensure transparency within the National Medicines Regulatory Authority (NMRA), we are implementing a new procedure for accessing the Google sheet titled "Reviewing Status of New Medicinal Products" available on the NMRA website.

To facilitate this, we kindly request each company to provide one email address that will be used to access the aforementioned Google sheet by scanning and filling the below QR code on or before 20th of November 2024. This step is crucial for maintaining a streamlined and secure review process.

Your cooperation in this matter is highly appreciated.

https://docs.google.com/forms/d/e/1FAIpQLSdJfGjk9NJ-qkW-OD-lXgh1KwHoqVXpTJp-TWj1oGM1jbV9gQ/viewform?usp=sf_link

CEO 
NMRA

Regulatory Updates

Registration of Cefuroxime injection 1000 mg

November 4, 2024

Cefuroxime injection 1000 mg is not accepted for registration under "Need" clause.

Complaints QR Code
Scan the QR code below to submit your complaints.
Reporting falsified / Counterfeit Products
Scan the QR code below to report falsified or counterfeit products.