Official Malaysian Government Website
NPRA mission
Regulatory control of medicinal products and cosmetics.
Register your productsQuick entry
Product classification, QUEST5 system basics, ASEAN guidance documents and the guideline for submitting product samples for laboratory testing.
EnterThe QUEST5 back end for NPRA officers: evaluation, screening, and the administrative functions behind product registration.
EnterThe complete guidance document, its main body on its own, and the directive that issued the current revision. Individual appendices are listed on the page.
EnterTwo desks answer industry questions: the One Stop Centre for general enquiries about registration, licensing and guidelines, and QUEST / ICT technical support for problems with the system itself. Choose the section that fits your question and your enquiry is tracked from the first message to resolution.
Report suspected adverse drug reactions and adverse events following immunisation to the National Centre for Adverse Drug Reactions Monitoring.
Applications
Before you start
Sections
Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials.
EnterAmong 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.
EnterThe 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.
EnterAny matters related to inspection of bioequivalence (BE) centres & listing of ethics committee (EC) with Drug Control Authority (DCA).
EnterGood 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.
EnterAny 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.
EnterA 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.
EnterMedicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.
EnterQUEST5 registers
What we regulate
Any preparation intended to be placed in contact with various external parts of the human body.
EnterTraditional (General) & Traditional (Medium).
EnterBioequivalence (BE), Prescription (Full), Non-Prescription (Full & Abridge).
EnterBiological/Biotech/Biosimilar, Vaccines, Blood Products & Others.
EnterNew Chemical Entity/Radiopharmaceutical Substances, New Combination Products, Supplemental Products.
EnterGeneral, Functional (Medium) & Disease Risk Reduction (High).
EnterScheduled Poison, Non-Poison, Innovator/NCE.
EnterDrug-Medical Device And Medical Device-Drug Combination Products.
EnterReference
QUEST5 Info, Classification, Lab & Clinical Trials, Basic Guidelines, ASEAN Guidance Documents
API Guidelines, API Circulars & API FAQs
Test Checklist, List of private laboratories & Guideline For The Submission Of Product Samples For Laboratory Testing
Reporting ADR, Post-Marketing Activities
GMP, GDP, Inspection & Licensing (Manufacturer, Importer & Wholesaler)
OECD GLP Documents, Application Procedures, GLP Compliant Test Facilities
Good Laboratory Practice (GLP) Compliance Monitoring Programme Main Page
Updates
QUEST5 Login
