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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 MoreNational Medicines Regulatory Authority,
State Engineering Corporation Building (2nd Floor),
No. 130,
W.A.D Ramanayaka Mawatha,
Colombo 02,
Sri Lanka
We wish to inform about the regulatory approach concerning the use of N-acetylcysteine (NAC) as an ingredient in borderline products.
Based on safety concerns and lack of conclusive evidence supporting the benefits of NAC, it has been determined that: N-acetylcysteine (NAC) should not be permitted for use in borderline products.
This decision reflects a precautionary approach to safeguard public health and ensure regulatory compliance.
The NMRA has identified a shortage of Lignocaine Throat Spray in the country. In order to ensure continued availability of this essential medicine for patients, NMRA will be accepting and evaluating product registration applications for Lignocaine Throat Spray with immediate effect.
Applicants are kindly requested to:
· Submit complete dossiers in accordance with the applicable regulatory guidelines.
· Ensure that product quality, safety, and efficacy data are provided as per NMRA requirements.
All submissions will be subject to the standard regulatory review process with priority attention due to the shortage situation.
For further information or clarification, applicants may contact the Medicines Regulatory Division, NMRA.
All marketing authorization holders of medicine are here by informed that NMRA has decided to prioritize sample import license applications of reliance products having less than five registered products. Please inform them with evidence for reliance.
For further clarification on any of the above points, please contact Medicine Regulatory Division, NMRA
The National Medicines Regulatory Authority(NMRA) successfully conducted a two-day training program on “Ensuring Regulatory Compliance in Clinical Trials: GCP and Inspections for Regulators”on 9th and 10th September 2025 at SLF. The program was designed to strengthen the capacity of regulators, inspectors, and clinical research professionals in ensuring compliance with international standards for ethical and high-quality clinical trials. Throughout the training, participants gained valuable insights into the latest updates on ICH-GCP E6(R3) guidelines, the conduct of GCP inspections, and both theoretical knowledge and essential soft skills such as communication and critical thinking. Sessions also focused on regulatory expectations, inspection readiness, and practical approaches to enhancing clinical trial oversight. In addition, case studies and interactive discussions with experienced experts provided participants with practical, real-world perspectives.
The training brought together a diverse group of professionals, including Prof. Asita de Silva, Madeline Ducatte (USA), Dr.Chamini Kanatiwela, and ACRP-certified auditors P. Ellawala and S. Ajanthan,fostering collaboration and knowledge sharing to strengthen the conduct of clinical trials in Sri Lanka. Renowned clinical trial experts Prof. Channa Ranasinghe, Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Dr. Nadeeka Chandrarathne, and Dr. Nuradh Joseph further enriched the sessions by sharing their extensive expertise and practical experience, fostering meaningful discussions and deeper understanding among participants. The program concluded with positive feedback, highlighting NMRA’s strong commitment to ensuring GCP compliance and readiness for future inspections.
It is hereby informed to all stakeholders, including manufacturers, importers,distributors, healthcare providers, and end-users, about updates related to medical devices within our jurisdiction.
Any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of Laser procedures, Micro needling, Thread lifting, Cavitation, Electro muscle stimulation, High intensity ultrasound tightening and Fraxel radio frequency technology for skin tightening should be registered under the medical devices.
For further information or clarification on any of the above points, please contact Medical Device Regulatory Division, NMRA.
ChiefExecutive Officer-NMRA
