Regulatory Authority: NMRA Sri Lanka
The NMRA (National Medicines Regulatory Authority) is the cornerstone of regulatory oversight in Sri Lanka, housed under the Ministry of Health (MOH). This robust regulatory body plays a pivotal role in ensuring the safety, efficacy, and quality of pharmaceuticals, traditional medicines, health supplements, food, medical devices, and cosmetics.
Key Regulatory Processes: A Roadmap for Exporters
Company registration:
- Time Frame: 8-12 Months (Application as per guidelines).
- A meticulous company registration process is a crucial initial step. Exporters are advised to adhere to the guidelines for a seamless experience.
CTD Dossier Submission:
- Submission on the NMRA portal is mandatory, following the Common Technical Document (CTD) format.
- Duration of NMRA Dossier Evaluation: 18-22 Months.
Regulatory assessment fees:
The regulatory assessment fee ranges from 900 to 1200 USD
Import samples:
- Import samples with a shelf life of 2 years or 3/4th of the product’s remaining shelf life.
- Duration: Essential for the evaluation process.
Renewal of CTD Dossier:
- To be initiated 6 months before expiry.
- Samples with a 1-year shelf life must be included.
NMRA’s Focus on Health System Improvement:
Over the next five years, the MOH has outlined three priority goals for Sri Lanka’s health system, emphasizing areas such as maternal and child health, infectious diseases, and non-communicable diseases.
Pharmaceutical Online Registration System (Cam PORS):
The advent of Cam PORS streamlines the registration process, providing a user-friendly online platform for pharmaceutical registration.
Price Control:
Prices are under controlled by NMRA.
Borderline Products Evaluation Committee (BPEC):
For products falling into the borderline category, the BPEC is the regulatory division overseeing evaluations.
As Sri Lanka marches towards enhancing its healthcare landscape, the NMRA provides a structured framework for pharmaceutical exporters. While challenges exist, the potential for market entry and growth is substantial. It’s imperative for exporters to stay abreast of evolving guidelines, contribute to ongoing discussions, and collaborate with regulatory bodies to ensure a smooth and compliant market entry. In this dynamic regulatory landscape, exporters must not only meet current standards but also be agile in adapting to future changes.
Contact on given details.
e-mail: anum@pharmadra.net
WhatsApp:
+971556308897