National Medicines Regulatory Authority (NMRA) is the drug Regulatory Authority under Health Ministry in Sri Lanka. NMRA mainly regulates and evaluates the medicinal products/drugs, devices, cosmetics and the manufacturing facilities with or without site visits. NMRA issues wholesale licenses, retail licenses and transport licenses for medicinal products/drugs and devices. NMRA along with the Consumer Affairs controls the pricing for selected drugs and devices In the Sri Lankan market. Under 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 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 NMRA (National Medicines Regulatory Agency)’s classification of medicines such as:
- New Chemical Entity (NCE)
- New Dosage Form (NDF)
- New Combination Products (NCP 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 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 of its WHO pre-qualified products should submit 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, 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 manufacturing site located in following countries (USA, Canada, UK, Europe, Japan, South Korea, Australia, Singapore, and Malaysia), the NMRA visit is not required, unless they have a certain reason for inspection.
F) Other important things to be considered
- Narrow Therapeutic, Antibiotics, Tranquilizers and Slow release or extended release drugs need a bioequivalence study with the original products (only for Generics and Branded Generics).
- WHO GMP certification qualification is mandatory to get site registration and product registration. It is must for API manufacturers also to have WHO GMP certification to register their finished products.
- Sri Lanka follows US Pharmacopeia, BP, JP
Product Maintenance & Compliance
Validity of Registration Certificate
The certificate of registration is valid for 5 years.
The renewal application should be submitted 6 months before expiration of the existing registration certificate along with documents mentioned in the format given in Schedule IV, Form A.
Post Approval Changes(Variations)
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
- Pharmaceutical Dossier Preparation and Submission to the NMRA
- Gap analysis of the dossier, as per the National Medicines Regulatory Authority (NMRA) Regulatory 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