About NMRA
The National Medicines Regulatory Authority (NMRA), plays a leading role in protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality and efficacy. The Authority regulates medicines, medical devices, borderline products, clinical trials and cosmetics. The National Medicines Quality Assurance Laboratory (NMQAL), charged with ensuring quality of medicinal products, also functions under the purview of the NMRA.
We are an independent authority in the Ministry of Health established in 2015 through an Act of Parliament. The NMRA is governed by a board. The board is responsible for providing strategic leadership and advising on overall functioning of the authority to ensure targets set out in the corporate plan and policies of the government are achieved. The Board doesn’t have any involvement in regulatory decision making. These are the responsibility of the chief executive, working with regulatory and other staff and expert advisory committees.
The Authority places great importance on the transparency of its decision-making concerning the market authorization of medicinal products, the context within which such decisions are made, and the conduct of its expert committees as well as the organization’s staff. We strive to ensure regulatory decisions are based on evidence in fairness to all stakeholders.
Our primary objective is to increase patient access to quality-assured medicinal products.
NMRA has a code of conduct in order to help our staff in this respect. This Code of Conduct sets out the standards of conduct to be observed by all NMRA staff, including members of the board and external experts. The aim of this integrity policy is to ensure that Board members and staff continually maintain and improve their integrity, impartiality and independence in order to guarantee the quality of the NMRA’s work and decision-making.
Our work includes :
- Assessing the need of a medicinal product to be made available to the public
- Registration and licensing of medicines that meet applicable quality and safety standards and are cost-effective
- Providing guidance on classification of medicines, medical devices, borderline products and cosmetics
- Ensuring medicinal products are appropriately manufactured, stored, distributed and dispensed
- Regulating prices of medicinal products to ensure they are available to the general public at reasonable prices
- Registration and regulation of pharmacies to ensure they comply with good pharmacy practices
- Recommending appropriate amendments to relevant laws pertaining to regulation of medicinal products
- Ensuring promotion and advertising is fair, balanced and evidence-based
- Educating the general public on proper use of medicinal products
- Supporting post-marketing surveillance
- Regulating all matters pertaining to the conduct of clinical trials
- Supporting initiatives for local manufacture of medicinal products
Mission & Vision
Vision
“Improve access to quality medicines, healthcare products and cosmetics”
Mission
“Provide regulatory oversight and evidence-based decisions for medicines, healthcare
products and cosmetics to ensure their Safety, Quality and Efficacy for the benefit of
people of Sri Lanka”
NMRA Organization Chart
Board Members
Director General / Chief Executive Officer
Management Team
Mrs. D.D Bulathsinhala |
|
Mrs.Gowrie Kathriarachchi |
|
Mrs. K.M.Y.K Karunarathna |
Regulatory Team
Achievements
On 21st October 2016, Sri Lanka transformed the pricing of essential medicines, making drugs more affordable for patients. The Government issued a notice by Extraordinary Gazette setting a price ceiling for 48 essential medicines used to treat noncommunicable diseases (NCDs), such as diabetes, heart disease, high blood pressure, high cholesterol, and other common diseases.>
NMRA Quality Policy
Quality Policy of National Medicine Regulatory Authority (NMRA)
The Quality Policy set by the NMRA expresses a commitment to implement a system of quality management based on continuous improvement. It is also disclosed, known and understood by all staff.
Quality Policy
NMRA is committed to protect the health of people of Sri Lanka and fulfill their duties with professional and scientific rigor, while ensuring safety, efficacy and quality and cost effective medicine, medical devices, borderline products, cosmetics and laboratory activities according to the Drugs Acts, Rules, Ordinances, Regulations and the amendments made there under.
NMRA shall work through effective, transparent and timely manner, ensuring implementation of Quality Management system which is continuously improved.
To meet our commitment, we must:
- Foster a team approach.
- Emphasize appropriate training for all employees.
- Recognize each employee's responsibility for quality.
- Provide regulations with timely written corrective actions.
- Earn recognition of our quality process and progress.
- Provide a framework for establishing and reviewing quality objectives.
- Develop and achieve Quality Improvement Goals.
- Review and renew this Quality Policy on a regular basis.