National Medicines Regulatory Authority - NMRA

Automation of the Licensing Process for Retail Pharmacy, Wholesale Pharmacy and Transportation of therapeutic goods by NMRA has been automated from September of 2019, through the e-NMRA 2019.

Therefore, applicants are advised to submit their application directly to NMRA by logging to http://enmra.nmra.gov.lk

Please note that hereafter applications will not be accepted manually.

For further inquires please contact: 070 585 0498, on weekdays from 8.30 am to 4.30 pm.

Today in Sri Lanka healthcare costs are escalating, with large amounts being spent on medicines and these amounts continue to increase, making it a growing challenge for Sri Lanka. Hence, this calls for a fair pricing model for both drug development and drug supply and to exercise a necessary form of medicine price control in the country.

One possibility to make this happen is for policymakers to agree and to define prices for medicinal drugs based upon its value. This will increase affordability and accessibility of medicines while promoting valued innovation.

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NMRA and WHO hold workshop on medicine pricing policies Today in Sri Lanka healthcare costs are escalating, with large amounts being spent on medicines and these amounts continue to increase, making it a growing challenge for Sri Lanka. Hence, this calls for a fair pricing model for both drug development and drug supply and to exercise a necessary form o...

NMRA’s aim is to support sustainability of SL’s health system and minimize out-of-pocket expenses on medicines — Prof Asita de Silva

All countries grant registration to medicines after carefully considering their cost-effectiveness. With an investment of less than 2% of the GDP on health in Sri Lanka, the requirement to assess cost-effectiveness of any medicine prior to granting registration is an important consideration for the national regulator of medicines.

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This Medical Product Alert relates to two falsified products circulating in Iran and Pakistan, namely n°1: GULUCATIME and n°2: GLUCANTIME which claim to contain meglumine antimoniate for the treatment of leishmaniosis. Both falsified products are presented in clear glass ampoules and falsely claim to be manufactured for Tillotts Pharma AG. Circulation of these falsified medical products is confirmed in the WHO Region of the Eastern Mediterranean.

The results of laboratory analysis facilitated by WHO indicates that the product GULUCATIME was not manufactured in accordance to good manufacturing practices.

WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified medical products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products.

If you are in possession of the above specific products, please do not use. If you have taken these falsified medical products, or if you suffer an adverse event or an unexpected lack of efficacy, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/ National Medicines Regulatory Authorities/ National Pharmacovigilance Centre.

The World Health Organization, Regional Office for South-East Asia (WHO-SEARN) organized the 3rd Annual Meeting of the SEARN which was held from 24 – 25 April 2019, in New Delhi, India.

At this event, the Member States of WHO South-East Asia Region, launched SEARN to enhance information sharing, collaboration and convergence of regulatory practices across the Region to guarantee access to high-quality medical products that include vaccines, diagnostics and medical devices.

The Second Annual Meeting of the SEARN was also held in Colombo, Sri Lanka from 21 – 23 March 2018.

Since then, progress on the Steering Group (SG) and Working Group (WG) deliverables were being made through teleconferences with SG and WG members.

The main objective of the 3rd Annual Meeting was to promote collaboration among Regulatory Agencies for Medical Products in South-East Asia Region that included reviewing the progress of the Steering Group (SG) and the five area specific Working Groups (WGs) on the deliverables, promoting collaboration and agreement of the Strategic plan 2019 – 2023 for SERN.

The meet had delegates from seven South-East Asian Regulatory bodies namely, Bhutan, Nepal, Bangladesh, Sri Lanka, and the Maldives.

The affordability of essential medicines is a key prerequisite for expanding proper treatment and care and health and safety in any country with the Health and regulatory systems in any country taking a key role in such initiatives.

NMRA conducted extensive discussions and consensus was reached on the need to regulate the price of essential medicines and the appropriate pharmaceutical pricing formula for Sri Lanka.

This lead to Sri Lanka recently transforming the pricing of essential medicines and 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 non communicable diseases (NCDs), such as diabetes, heart disease, high blood pressure, high cholesterol, and other common diseases.

Upon issuing the gazette notification, the Hon. Minister of Health, Nutrition and Indigenous Medicine, Dr Rajitha Senaratne said that the prices of certain drugs could be reduced up to 85 % as a result. The revised pricing policy is a major achievement in safeguarding patients’ rights to access affordable medicine in Sri Lanka.

“The price reductions on the 48 essential drugs based on the maximum retail price formula, are expected to have a very positive impact on the cost of these essential medicines,” stated Professor Asita de Silva, Chairman of the National Medicines Regulatory Authority, Sri Lanka.

Sri Lanka’s successful regulation of pharmaceutical prices shows how evidence based policies can protect patients’ rights, reduce out of pocket expenditure, ensure affordable access to quality assured medicines and advance the principles of Universal Health Coverage.

NMRA recently organized a workshop focused on the personal transformation of their employees.

The participants comprised of a diverse group of staff from the various divisions within NMRA. At the onset, the participants were given the opportunity to share their concerns and challenges faced in their day to day work and focused on how to achieve the best possible outcomes.

The workshop also encompassed a series of interactive exercises probing the participants to critically evaluate their short and long-term goals and the motivation behind them.

Leading the sessions was Mr W.P Nimal Weerasinghe, Labour Officer at the Labour Department.

The learning outcomes during the workshop were focused on self-improvement, taking responsibility for one’s actions, handling customers in the right manner, teamwork and in inspiring positive changes in the workplace The interactive nature of the workshop ensured the active participation from attendees and reinforced the importance of positive and pro-active behaviour’s.

Workshops of this nature are held by NMRA to improved employee satisfaction and morale and deliver a high level of performance.

The National Medicines Regulatory Authority (NMRA) had their representatives participating in the SEA Regional Training Workshop to use the WHO New Benchmarking Tool to Strengthen National Regulatory Systems, in Jakarta, Indonesia in June 2017.

Using these learnings, the NMRA subsequently conducted a self-benchmarking of their regulatory system using WHO Global Benchmarking Tool indicators. A WHO mission was invited in February 2018 to review all indicators with NMRA responsible of each regulatory function.

Subsequently, two training priorities were identified on Good Manufacturing Practices (GMP) and on Pharmacovigilance to be implemented during the first quarter of 2019. The WHO was to support and facilitate the training of NMRA inspectors. The training material used for the workshop was developed by WHO with the collaboration of NRA GMP experts from LMIC.

The workshop conducted for a period of 5 days with top experts from WHO as it’s facilitators, resulted in regulatory inspectors responsible for vaccine and medicine manufacturers GMP compliance improving and updating their knowledge on GMP requirements , better understanding the different levels of GMP to produce pharmaceutical, vaccine and biologicals, the GMP certification process and documentation, and in improving their skills in conducting GMP inspections.

National Medicines Regulatory Authority (NMRA) recently launched their updated and newly integrated user-friendly website.
This is in-line with the Authority’s new initiative to digitalize its workflow processes.

The new website (www.nmra.gov.lk) offers users a fresh online experience with easier access to in-depth information about NMRA’s services and industry-relevant news including regulatory details, medicine and medical equipment legislation and clinical trials.

Topics covered in the website include how to get submissions right first time around for medicinal products, details of regulatory workflow, guidelines and emerging issues for the regulation of medicines, medical devices and borderline products. The website will also be regularly updated with the latest industry relevant news.

The key intention of the website is to simplify and communicate information more effectively and to enhance the overall user experience, helping to convey NMRA’s position as the key regulator in the country and the important role they play in protecting and advancing national health and safety.

NMRA has additionally launched a new social media channel to further communicate and update all relevant information regarding medicines and their regulation.

Consumers can now use the website to find details and tips on the safety of medicines and medical devices, while health professionals can use it to follow the latest news and guidance on the regulation of medicines and medical devices.

The Chairman of NMRA, Professor Asita de Silva commented ‘we are confident that the new website will provide greater value to the general public, and other stakeholders and will build a better understanding amongst those who are looking to submit applications for marketing medicines and medical devices and clinical trial authorizations and enable users to access our services with ease.“

He added “the site redesign and updated content showcases and builds better awareness of our strengths and expertise as the country’s regulator of medicines and the role we play every day in protecting the health and safety of all Sri Lankans.

Furthermore, our newly designed website is another opportunity for us to connect directly with our stakeholders, the general public and consumers and help them engage with us on issues that are important to them.”

Through the launch of the new website and social media pages, NMRA joins a growing community of health regulators across the world who engage with the public on promoting and educating them on the quality and safety of medicines and healthcare.

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 that is deployed by EPIC Technology Group, will go towards providing better regulatory services to all its stakeholders and will bring a new dimension to help improve medicines regulations and thereby improve public health.

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.