The National Medicines Regulatory Authority (NMRA) is the drug Regulatory Authority under the Health Ministry in Sri Lanka. The NMRA mainly regulates and evaluates the medicinal products/drugs, devices, cosmetics, and manufacturing facilities with or without site visits. The NMRA issues wholesale licenses, retail licenses, and transport licenses for medicinal products/drugs and devices. The NMRA, along with the Consumer Affairs, controls the pricing for selected drugs and devices in the Sri Lankan market. Under the NMRA, there is a sub-department to approve labeling and advertising.
The Medicines Evaluation Committee (MEC), formed under the NMRA Act, carries out scientific and technical reviews, inspections, and surveillance activities of the medicines forwarded for registration to ensure the quality, efficacy, safety, and cost of such medicines as per the registration and certification procedures.
Medicinal Product Classification
While submitting pharmaceutical product registration applications, manufacturers must consider the NMRA’s classification of medicines, such as:
- New Chemical Entity (NCE)
- New Dosage Form (NDF)
- New Combination Products (NCPs are not allowed for oral capsules and solids)
- Existing Chemicals New Product (NP)
- Biologics/Biosimilar Products
Medicinal Product Registration
A) Two-Step Market Authorization Procedure
Step 1 – Manufacturing Site Registration and Sample Import License
- Approval of the new manufacturer for registering medicines
- Obtaining a sample import license (applicable only for foreign manufacturers)
Step 2 – Marketing Authorization Application
The market authorization application must be submitted along with the documents mentioned in the format given in Schedule IV, Form A of the Cosmetics, Devices, and Drugs (CDD) Regulations with drug samples to the NMRA.
B) Collaborative Registration with the WHO
- WHO pre-qualified products can be registered with the NMRA through a verification procedure.
- Manufacturers interested in marketing one (01) of their WHO pre-qualified products should submit the completed Appendix 2 to the WHO and Appendix 3A to the NMRA.
C) Prior Approval with Reference Health Authorities
The review process from the NMRA may be expedited for pharma market access if the products are registered with any of the reference Health Authorities as mentioned below:
D) Importance of the Local Entity for a Foreign Manufacturer
For a foreign medicinal product manufacturer, it is mandatory to have a local entity or local presence in Sri Lanka, and all applications must be furnished through the local agent to the NMRA.
E) Waiver for on-site GMP inspections
- If the manufacturing sites are located in the following countries (USA, Canada, UK, Europe, Japan, South Korea, Australia, Singapore, and Malaysia), an NMRA visit is not required unless they have a certain reason for the inspection.
F) Other important things to be considered
- Narrow therapeutics, antibiotics, tranquilizers, and slow-release or extended-release drugs need a bioequivalence study with the original products (only for generics and branded generics).
- A WHO GMP certification is mandatory to get site registration and product registration. It is a must for Active Pharmaceutical Ingredient (API) manufacturers also to have a WHO GMP certification to register their finished products.
- Sri Lanka follows the US Pharmacopeia, BP, and JP.
Product Maintenance & Compliance
Validity of Registration Certificate
Post Approval Changes(Variations)
The certificate of registration is valid for five (05) years.
The renewal application should be submitted six (06) months before the expiration of the existing registration certificate along with documents mentioned in the format given in Schedule IV, Form A.
Any change of registered medicine should be sent to the NMRA with relevant documents.
- End-to-end Pharmaceutical Product Registration
- Authorized Local Representation
- NMRA Manufacturing Site Registration
- Sample Import License Support
- Regulatory Affairs Consulting
- Pharmaceutical Dossier Preparation and Submission to the NMRA
- Gap Analysis of the Dossier, as per the National Medicines Regulatory Authority (NMRA) Requirements
- Preparation of Gap Analysis Report and Remediation Plan
- Query Support Management till Approval
- Pharmaceutical Lifecycle Management Support
- Pharmaceutical Artwork Management
- Ad-hoc Regulatory Affairs Consultation
- Local Distribution