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Jata Negara Malaysia Ministry of Health Malaysia National Pharmaceutical Regulatory Agency
Industry

PRODUCT CATEGORIES

  • Biologic
  • Combination Products
  • Cosmetic Products
  • Generic Medicines
  • Natural Products
  • Health Supplement
  • New Chemical Entity (NCE)
  • Veterinary Medicine

REGULATORY INFORMATION

  • Basic Regulation
  • Active Pharmaceutical Ingredients (API)
  • Bioequivalence and Ethics Committee Inspection
  • Compliance and Licensing
  • Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
  • Laboratory & Quality Control
  • Medicinal Gases
  • Pharmacovigilance
  • Phase I Unit Inspection & Accreditation Programme
  • Surveillance & Complaints

MORE REGULATIONS

  • Industry Main Page
  • Drug Registration Guidance Documents (DRGD)
  • Helpdesk Enquiry
  • In House Application
  • Market Sampling
  • QUEST Updates and Announcements
  • Medicine Shortage & Discontinuation Reporting
  • Recent Updates
QUEST5 Submit, track and manage registrations and licences online. Open QUEST5
Consumers

Reporting

  • Reporting on Notified Cosmetic Products
  • Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)
  • Quality Reporting on Registered Product

Consumer Information

  • Consumer Main Page
  • Products Search
  • Technical Evaluation Summary
  • e-Brochures
  • Vaccine Lot Release : Lot Release Certificate
  • Plasma Products Lot Release : Lot Release Certificate
  • Online Public Engagement
  • Contact Us
  • Lot Release for Covid-19 Vaccines

Safety Information

  • Cancellation of Registered Complementary & Alternative Product
  • Cancellation of Notified Cosmetic Products
  • Adulterated Products ( Unregistered )
  • Vaccine Lot Release : Notification of Non Compliance
  • Plasma Products Lot Release : Notification of Non Compliance
  • Product Recall
Health Professionals

Health Professionals

  • Health Professionals Main Page
  • Safety Alerts
  • Direct Healthcare Professional Communications (DHPCs)
  • #MedSafetyWeek
  • Reporting ADR / AEFI
  • Quality Reporting
  • MADRAC Bulletin
  • REAKSI Drug Safety News
  • Press Releases on AEFIs of COVID-19 Vaccines
  • Summary Reports on AEFIs of COVID-19 Vaccines
Information

General Information

  • Announcement
  • Press Release
  • Circulars & Directives
  • Training & Seminars
  • Research & Development
  • E-labelling

New Products / Indication

  • New Products Approved
  • Additional Indications Approved
  • New Chemical Entities
  • Biosimilars Approved
  • Surface Disinfectants Approved
  • Orphan Medicines Approved

QUEST List of Manufacturers / Wholesalers / Importers

  • QUEST 3+ License Search
  • List of Cosmetic Manufacturers in QUEST System

Annual Reports

  • NPRA Annual Reports
  • National Centre for Adverse Drug Reaction Monitoring Annual Report

Safety Information

  • Cancellation of Registered Complementary & Alternative Product
  • Cancellation of Notified Cosmetic Products
  • Adulterated Products ( Unregistered )
  • Vaccine Lot Release : Notification of Non Compliance
  • Plasma Products Lot Release : Notification of Non Compliance
  • Product Recall

Newsletter

  • Berita Ubat-ubatan
  • e-Brochures
  • Coffee Table Book
About NPRA

NPRA INFORMATION

  • Vision, Mission and Objective
  • Roles and Functions
  • Organisation Chart
  • NPRA's Clients Charter
  • NPRA's Quality Objective
  • NPRA Obligation
  • NPRA Quality Policy & MS ISO 9001:2015 Certification Scope
  • EKSA Bulletin
  • NPRA Safety Policy
  • Gallery
  • Online Public Engagement
  • Tawaran Iklan

Recognition & International Membership

  • WHO Collaborating Centre
  • PIC/S
  • OECD-GLP-MAD
  • NPRA Awards & Recognition

Useful Links

  • Staff Directory
  • Our Location
  • Public Enquiry

Drug Control Authority (DCA)

  • DCA Members
  • About the DCA
  • DCA Expert Advisor Panel
  • DCA News

Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)

  • MADRAC Introduction
  • MADRAC Members
QUEST5 LOGIN
Industry

    PRODUCT CATEGORIES

  • Biologic
  • Combination Products
  • Cosmetic Products
  • Generic Medicines
  • Natural Products
  • Health Supplement
  • New Chemical Entity (NCE)
  • Veterinary Medicine
  • REGULATORY INFORMATION

  • Basic Regulation
  • Active Pharmaceutical Ingredients (API)
  • Bioequivalence and Ethics Committee Inspection
  • Compliance and Licensing
  • Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
  • Laboratory & Quality Control
  • Medicinal Gases
  • Pharmacovigilance
  • Phase I Unit Inspection & Accreditation Programme
  • Surveillance & Complaints
  • MORE REGULATIONS

  • Industry Main Page
  • Drug Registration Guidance Documents (DRGD)
  • Helpdesk Enquiry
  • In House Application
  • Market Sampling
  • QUEST Updates and Announcements
  • Medicine Shortage & Discontinuation Reporting
  • Recent Updates
Consumers

    Reporting

  • Reporting on Notified Cosmetic Products
  • Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)
  • Quality Reporting on Registered Product
  • Consumer Information

  • Consumer Main Page
  • Products Search
  • Technical Evaluation Summary
  • e-Brochures
  • Vaccine Lot Release : Lot Release Certificate
  • Plasma Products Lot Release : Lot Release Certificate
  • Online Public Engagement
  • Contact Us
  • Lot Release for Covid-19 Vaccines
  • Safety Information

  • Cancellation of Registered Complementary & Alternative Product
  • Cancellation of Notified Cosmetic Products
  • Adulterated Products ( Unregistered )
  • Vaccine Lot Release : Notification of Non Compliance
  • Plasma Products Lot Release : Notification of Non Compliance
  • Product Recall
Health Professionals

    Health Professionals

  • Health Professionals Main Page
  • Safety Alerts
  • Direct Healthcare Professional Communications (DHPCs)
  • #MedSafetyWeek
  • Reporting ADR / AEFI
  • Quality Reporting
  • MADRAC Bulletin
  • REAKSI Drug Safety News
  • Press Releases on AEFIs of COVID-19 Vaccines
  • Summary Reports on AEFIs of COVID-19 Vaccines
Information

    General Information

  • Announcement
  • Press Release
  • Circulars & Directives
  • Training & Seminars
  • Research & Development
  • E-labelling
  • New Products / Indication

  • New Products Approved
  • Additional Indications Approved
  • New Chemical Entities
  • Biosimilars Approved
  • Surface Disinfectants Approved
  • Orphan Medicines Approved
  • QUEST List of Manufacturers / Wholesalers / Importers

  • QUEST 3+ License Search
  • List of Cosmetic Manufacturers in QUEST System
  • Annual Reports

  • NPRA Annual Reports
  • National Centre for Adverse Drug Reaction Monitoring Annual Report
  • Safety Information

  • Cancellation of Registered Complementary & Alternative Product
  • Cancellation of Notified Cosmetic Products
  • Adulterated Products ( Unregistered )
  • Vaccine Lot Release : Notification of Non Compliance
  • Plasma Products Lot Release : Notification of Non Compliance
  • Product Recall
  • Newsletter

  • Berita Ubat-ubatan
  • e-Brochures
  • Coffee Table Book
About NPRA

    NPRA INFORMATION

  • Vision, Mission and Objective
  • Roles and Functions
  • Organisation Chart
  • NPRA's Clients Charter
  • NPRA's Quality Objective
  • NPRA Obligation
  • NPRA Quality Policy & MS ISO 9001:2015 Certification Scope
  • EKSA Bulletin
  • NPRA Safety Policy
  • Gallery
  • Online Public Engagement
  • Tawaran Iklan
  • Recognition & International Membership

  • WHO Collaborating Centre
  • PIC/S
  • OECD-GLP-MAD
  • NPRA Awards & Recognition
  • Useful Links

  • Staff Directory
  • Our Location
  • Public Enquiry
  • Drug Control Authority (DCA)

  • DCA Members
  • About the DCA
  • DCA Expert Advisor Panel
  • DCA News
  • Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)

  • MADRAC Introduction
  • MADRAC Members
QUEST5 LOGIN

Health Supplements

Guidelines for Health Supplements

Breadcrumb

  1. Home
  2. Health Supplements
  3. Guidelines for Health Supplements
  • Health Supplement Intro
  • Guidelines
  • Application Forms
  • Directives & Circulars
  • Frequently Asked Questions (FAQs)

Pengemaskinian Garis Panduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP)
published on 2025-03-07


Direktif Berkenaan Pelaksanaan Garis Panduan Guidance on the Acceptance Criteria for Quantification by Input (QBI) of Active Ingredients Claimed on Label of Traditional Medicine and Health Supplement (TMHS) Products
published on 2022-11-09


Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders (1st Edition, August 2021)
published on 2021-09-29


4.4 : Post-Marketing Activities
published on 2019-03-13


Appendix 6: Guideline On Registration Of Health Supplements
published on 2018-07-02


Malaysian Variation Guideline for Natural ( Traditional Medicine & Homeopathy ) and Health Supplement Product 2016
published on 2016-07-19


Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements
published on 2008-01-01


NPRA logo NPRA

National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Lot 36, Jalan Prof. Diraja Ungku Aziz, 46200 Petaling Jaya, Selangor.

+603-7883 5400

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