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    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
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  • #MedSafetyWeek
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  • Press Releases on AEFIs of COVID-19 Vaccines
  • Summary Reports on AEFIs of COVID-19 Vaccines
Information

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  • 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

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  • e-Brochures
  • Coffee Table Book
About NPRA

    NPRA INFORMATION

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  • NPRA's Clients Charter
  • NPRA's Quality Objective
  • NPRA Obligation
  • NPRA Quality Policy & MS ISO 9001:2015 Certification Scope
  • EKSA Bulletin
  • NPRA Safety Policy
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  • Online Public Engagement
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  • Recognition & International Membership

  • WHO Collaborating Centre
  • PIC/S
  • OECD-GLP-MAD
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Application Form - Clinical Trial

Guidelines for Clinical Trial

Written by kobu · 18 March 2026

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  3. Guidelines for Clinical Trial

 

Document Name Updated
Malaysian Guidelines for Good Clinical Practice 5th Edition Mac-26
Malaysian Guideline for Application of CTIL and CTX 8.1th Ed (Effective on 30 April 2025) Mac-25
History of Minor Revision Malaysian Guideline for Application of CTIL and CTX 8.1th Ed May-25
Malaysian Guidelines for Good Clinical Practice (GCP) Inspection, Third Edition (2026) Mac-26
Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme Jun-18
Malaysian Guideline for Bioequivalence (BE) Inspection 2nd Edition Oct-24
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition Jun-16
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