Pharmaceutical /Medicine/Drug/OTC registration in Sri Lanka

MOH- Ministry of Health of Sri Lanka

MOH Website-https://www.health.gov.lk/

Regulatory Authority- The National Medicines Regulatory Authority (NMRA)

Regulatory Website-https://www.nmra.gov.lk/

 Local Authorized Representative Required-Yes

Drug Approval Process

Cosmetics, Devices, & Drug regulating Authority (CDDA) is Sri Lanka’s drug regulating body. The legislative foundation for regulating cosmetics, devices, and drugs is provided by the Cosmetic, Devices, and Drugs (CDD) Act No. 27 of 1980 (as revised by Act Nos. 38 of 1984, No. 25 of 1987, and No. 12. of 1993).

The nation’s usage of pharmaceuticals, medical equipment, and cosmetics. The CDD Act’s regulations were first published in Gazette Extraordinary No. 378/3 of 02/12/1985, and they are periodically amended.

One of the primary duties of the CDDA is drug registration. The assessment of the manufacturer’s adherence to good manufacturing practices (GMP) standards is the first stage in the medication registration process. Drug registration applications are only accepted if the applicable manufacturer’s production facilities meet all GMP requirements.

The health ministry intends to establish a Pharmaceuticals Standards Regulatory Authority to guarantee that medications used in the nation adhere to specific quality standards, which should result in an improvement in Sri Lankan regulatory standards. The ministry will have more legal jurisdiction to pursue low-quality drug imports due to the creation of the new authority. Currently, the Director General of Health is the only person in charge of managing regulatory clearances.

While local manufacturers are audited for GMP compliance by a team of officers linked to the Office of Medical Technology and Supplies (MT&S) and the National Drug Quality Assurance Laboratory (NDQAL), foreign manufacturers are assessed based on their corporate profiles.

Each foreign manufacturer operatingin Sri Lanka must designatean agent to handle registration and other matters pertaining totheir products there. Through the local agent, the manufacturer shall send registration applications and samples for quality testing to the Office of the Director of MT&S. The Substance Evaluation Committee (DESC), which is made up of experts in the medical and pharmaceutical domains, collaborates with the Ministry of Health’s administrative division to offer recommendations on drug registration. Effectiveness, safety, and quality are seen to be the primary requirements for registration.

Registration Fee

1.New Chemical Entities for Sri Lanka (NCE) – Rs. 50,000/= + VAT

2. New Dosage form application for Sri Lanka (NDF) – Rs.25,000 /= + VAT
3. New fixed dose combination products (NFDCs) – Rs.50,000 /= + VAT
4. New product of existing drugs – Rs.10,000 /= + VAT
5. Re-registration application – Rs.10,000 /= + VAT

   Renewing Your Registration

   Before six months have passed since the registration’s expiration date, an application for renewal must be submitted.

   There will be a grace period up until the application for renewal is decided.

   The application will be fully denied if any of the registration conditions are not met.