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.
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.
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.
Find Out MoreNational 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.
Find Out MorePharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.
Find Out MoreInspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.
Find Out MoreThis applies for local manufacturers only
For initial registration
Comparative Dissolution study data should be submitted according to the WHO guidelines for Comparative Dissolution or Biowaiver. The comparator for the dissolution study should be decided in consultation with the NMRA.
At the end of the Provisional Registration period, for conversion from provisional Registration to Full Registration.
Rolling Provisional Registration is granted for a maximum of four year within which a Bioequivalence study data should be submitted.
සෞඛ්ය අමාත්යාංශ ගොඩනැගිල්ල තුළ ජාතික ඖෂධ නියාමන අධිකාරිය ස්ථාපිත කිරීමට අදාළ මූල්ය කටයුතු සහ අනෙකුත් අත්යාවශ්ය සියලු කටයුතු සිදු කිරීම සම්බන්ධයෙන් අදාළ සියලු පාර්ශව සම්බන්ධ කරගනිමින් අවබෝධතා ගිවිසුමකට එලඹිය යුතුව ඇත.
ජාතික ඖෂධ නියාමන අධිකාරිය වෙනුවෙන් අවබෝධතා ගිවිසුම සකස් කිරීම සම්බන්ධයෙන් උනන්දුවක් දක්වන සිවිල් නීති ක්ෂේත්රයේ(ගිවිසුම් නීතිය) සම්බන්ධ වසර දහයක පළපුරැද්ද සහිත නීතිඥවරැන්ගෙන් අයඳුම්පත් කැඳවනු ලැබේ.රාජ්ය අංශයට ඉහත අවබෝධතා ගිවිසුම් සකස් කිරීමේ සේවා සපයා තිබීම විශේෂ සුදුසුකමක් වේ.
ඔබගේ සියලු තොරතුරු ඇතුළත් ජීව දත්ත පත්රිකාව සමඟ මිල ගණන් අප වෙත 2024.10.09 දින පස්වරු 02.00ට පෙර පහත ලිපිනයට ගෙනැවිත් භාරදීමට හෝ ලියාපදිංචි තැපෑලෙන් යොමු කිරීමට කටයුතු කරන්න.
ප්රධාන විධායක නිලධාරි,
ජාතිකඖෂධ නියාමන අධිකාරිය,
2 වනමහළ,
රාජ්ය ඉංජිනේරු සංස්ථා ගොඩනැගිල්ල,
ඩබ්.ඒ.ඩී.රාමනායක මාවත,
කොළඹ 02.
A memorandum of understanding should be reached involving all the relevant parties regarding the financial and other necessary activities related to the establishment of the National Drug Regulatory Authority in the Ministry of Health building.
Applications are invited from lawyers with ten years of experience in the field of civil law(contract law) who are interested in preparing MOUs on behalf of the National Drug Regulatory Authority. Having provided similar MOU preparation services to the public sector is a special qualification.
Submit your curriculum vitae with all the details and the price to us before 02.00 pm on 09.10.2024 to the address below or send it by registered post.
Chief Executive Officer
National Medicines Regulatory Authority
2 nd Floor
State Engineering Corporation
W.A.D.Ramanayake Mawatha
Colombo 02
All Market Authorization Holders of Medicines,
You are hereby informed that, effective from 27 September 2024, all market authorization holders are required to submit their eCTD dossiers using the following Google Form. This submission is in addition to the hard copy dossier submission.
Important Instructions :
Rename the eCTD dossier : Before submitting, please rename your eCTD dossier according to the dossier number received from the accepting counter.
Submission Deadline : Ensure that both the eCTD and hard copy dossiers are submitted by the specified deadlines.
We appreciate your corporation in this matter.
NMRA welcomes your comments & feedback on the guidelines for the Waivers of Registration (WOR) of Pharmaceutical products imported to Sri Lanka
This will be started from 19th of September 2024 to 30th of September 2024.
Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to p35@nmra.gov.lk & aa14@nmra.gov.lk by 30th of September 2024
Warfarin Tablets 2 mg accepted for registering in Sri Lanka and the colour code is Lavender
NMRA has decided to implement colour codes for Warfarin tablets in order to prevent the confusion in identifying different strengths by the patients.
0.5 mg - White
1 mg - Brown
2 mg - Lavender
3 mg - Blue
5 mg - Pink
Failing to abide this will create unnecessary problem when clearing at custom