The National Medicines Regulatory Authority (NMRA) is the government agency that regulates the manufacture, importation, sale and distribution of Medicines,and Devices and Borderline products in the country, with a vision of ensuring that medicinal products available in the country are manufactured, distributed and dispensed with the required quality, safety and efficacy.

Taking a pro-active role to take advantage of the advances in digital technology for the protection of public health, the NMRA recently announced their transition into automating its document and workflow systems.

The clear mission of this venture is strengthening the monitoring and evaluation mechanisms being built into the regulatory system, to assess and meet the specific medicines regulatory.

Implementation of phase one of the system going ‘live’ took place on the 11th of January with under the participation patronage of Hon. Minister of Health, Nutrition and Indigenous Medicine,. Dr. Rajitha Senaratne, and participation of Hon. Minister of  , Digital infrastructure and information technology, Mr. Ajith P. Perera, and senior officials of the NMRA and Information and Communication Technology Agency (ICTA), along with many other dignitaries from both the private and public sectors.

The system is being deployed by EPIC Technology Group, a leading technology organization that has made vast strides in successfully delivering cutting edge technology solutions for to many government agencies and private sector organizations.

Dr. Kamal Jayasinghe the CEO of NMRA in his welcome address emphasized the clear potential of this initiative to provide better regulatory services to all its stakeholders and praised the commitment of his team to implement digital systems in the Authority.

Following his address, the Chairman of NMRA Prof Asita De Silva outlined how this system will bring a new dimension to help improve medicines regulations and thereby improve public health.

He said “The production and distribution of medicines require end-to-end public regulatory oversight. Unlike ordinary goods and services, an unregulated medicines market will be dangerous to public health. Therefore, the task of overseeing and regulating medicines in any country is often formidable and challenging.

Thousands of products are available, supplied by large numbers of manufacturers and handled by numerous importers and retailers. NMRA is tasked with assessing and authorizing medicinal products  for market entry, as well as monitoring their effectiveness and safety after entry. In addition, we want to increase patient access to quality-assured medicines while reducing out pf pocket expenses. Over the past two years, we have regulated prices of more than 70 essential medicines as well as devices such as cardiac stents and intraocular lenses. This has resulted in an increase in the overall use of medicines. The positive public health impact of these initiatives will probably be seen in the future. We are determined to play the role of a modern regulator,  that has the health of the nation at the heart. It is to take forward this mission and further enhance our efficiency and transparency, that we have undertaken to digitalize our entire processes and operations.

Minister Rajitha Senaratne commended NMRA for this initiative and stated that it is a move taken in the right direction. “In this new digitalized and patient-centered era, robust real  world data will be vital to maximize the potential of delivering the correct solutions for the benefit of patients and I see NMRA taking the first steps towards making this happen”, he said. The Hon. Minister outlined his vision for a healthier Sri Lanka and concluded by saying he is “determined to achieve that goal despite many challenges.”

Minister Ajith P. Perera echoed similar sentiments and applauded the medicines regulator for its plans to use technology to carry out regulatory functions efficiently and transparently. He thanked the ICTA for supporting the NMRA in achieving this milestone and requested the Agency to carry forward its mandate to digitalize more government institutions.

This latest initiative by the NMRA stands as a clear demonstration of their vision of ensuring the safety of public health and in promoting meaningful regulations of medicines in the country.

Photo  Caption : Hon. Minister  Dr. Rajitha Senaratne at the launch .