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Regulatory Information

Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials.

Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts. These activities allow identification of drug safety issues, which are reviewed in order to implement preventative measures. NPRA also communicates information on drug safety issues to healthcare professionals and the public, in our ongoing effort increase patient safety.

The submission of sample for laboratory testing is as part of the registration process.This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.

Any matters related to inspection of bioequivalence (BE) centres & listing of ethics committee (EC) with Drug Control Authority (DCA)

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of GLP is to promote the development of quality data.

Any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s License, Import License or Wholesale License. Licensing & Certification Section is involved in the activity of issuance of License.

A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. This will be done through standardized quality assessment and inspection procedures.

Medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.


Product Categories

Browse Guidelines, Directives, Circulars, Announcements and Application Forms according to Product Categories


Any preparation intended to be placed in contact with various external parts of the human body

Natural Products

 Traditional (General) & Traditional (Medium)

Generic Medicines

Bioequivalence (BE), Prescription (Full), Non-Prescription (Full & Abridge)


Biological/Biotech/Biosimilar, Vaccines, Blood Products & Others

New Chemical Entity

New Chemical Entity/Radiopharmaceutical Substances, New Combination Products, Supplemental Products

Health Supplements

General, Functional (Medium) & Disease Risk Reduction (High)

Veterinary Medicines

Scheduled Poison, Non-Poison, Innovator/NCE

Combination Products

Drug-Medical Device And Medical Device-Drug Combination Products


National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 24 July 2024, 10:26:11.
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