Regulatory Information

Regulation Basics

QUEST3+ Info, Classification, Lab & Clinical Trials, Basic Guidelines, ASEAN Guidance Documents

Laboratory & Quality Control

Test Checklist, List of private laboratories & Guideline For The Submission Of Product Samples For Laboratory Testing

Licensing & Inspection

GMP, GDP, Inspection & Licensing (Manufacturer, Importer and Wholesaler)

Active Pharmaceutical Ingredient (API)

API Guidelines, API Circulars & API Faqs

Good Laboratory Practice (GLP)

OECD GLP Documents, Application Procedures, GLP Compliant Test Facilities

Pharmacovigilance

Reporting ADR, Pos-market Activities

Product Categories

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

Cosmetics

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

Natural Products

 Traditional (General) & Traditional (Medium)


Generic Medicines

Prescription (Full), Non-Prescription (Full) & Non-Prescription (ABRIDGE)

Biologics

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



Combo Products

Products comprised of two or more regulated components 


National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

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: Friday 19 October 2018, 16:57:45.
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