Welcome to Guidelines Central - the section of our NPCB Portal where we have placed all published guidelines into one central bank for your convenience.

• Guidelines
  • Guidelines - MADRAC
  • Malaysian Guidelines for the Reporting & Monitoring (March 2002) (pdf, 126.41 KB)
  • Guidelines - Regulatory Information
  • Malaysia Variation Guideline for Pharmaceutical Products 2013 (First Edition) (pdf, 563.47 KB)
  • Drug Registration Guidance Document (DRGD) (updated 30 April 2013) (pdf, 4.84 MB)
  • Jadual Pengkelasan Medical Device - Drug - Cosmetic Interface.pdf (pdf, 147.04 KB)
  • Malaysian Transition Strategy for the Phase Out of Chlorofluorocarbon in Metered Dose Inhalers (pdf, 19.92 MB)
  • Guideline for Application for Registration of Biologicals / Biotechnology Products (doc, 35.00 KB)
  • Garispanduan Pelaksanaan Risalah Maklumat Ubat untuk Pengguna (RiMUP) April 2013 (pdf, 382.69 KB)
  • Regulatory Control of Active Pharmaceutical Ingredients (pdf, 203.91 KB)
  • Good Distribution Practice (pdf, 519.26 KB)
  • Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements (pdf, 262.56 KB)
  • Guidance Document and Guidelines for Registration of Biosimilars in Malaysia (pdf, 165.51 KB)
  • Classification decision tree - Guidance on Classification (Oct2011) (pdf, 720.91 KB)
  • Guidelines for the Establishment, Handling, Storage and Use of Chemical Reference Substances (pdf, 24.52 KB)
  • Garispanduan Penyediaan, Pengendalian, Penyimpanan dan Penggunaan Piawai Rujukan Kimia (pdf, 25.29 KB)
  • ASEAN Labelling Requirements (Annex 16) (pdf, 127.56 KB)
  • Guidelines - Veterinary
  • Supplementary Guidelines on GMP for Veterinary Premixes Supplements and Herbal_Natural Preparations (Final).pdf (pdf, 378.69 KB)
  • Arahan PKPF - Supplementary Guidelines on Veterinary Premixes.pdf (pdf, 832.41 KB)
  • Registration Guideline of Veterinary Products (REGOVP) - Version 2 Dec 2009 (pdf, 897.44 KB)
  • GMP Guidelines for Veterinary Products (pdf, 50.04 KB)
  • Guidelines - Clinical Trial
  • Senarai Jawatankuasa Etika yang berdaftar dengan PBKD - Januari 2013 (pdf, 6.19 KB)
  • Guidelines for the Application of CTIL CTX 5 Edition (Version 4.1) (pdf, 507.85 KB)
  • Guidelines for Good Clinical Practice (GCP) Inspection (pdf, 285.87 KB)
  • Malaysian Guidelines for Good Clinical Practice (pdf, 2.18 MB)
  • Guidelines for Control of Cosmetic Products in Malaysia
  • Guidelines for Control of Cosmetic Products in Malaysia (pdf, 186.04 KB)
  • Annex I Part 1: Membership Registration for QUEST 3 System (pdf, 6.32 KB)
  • Annex I, Part 2: Illustrative List of Cosmetic Product by Categories (pdf, 163.55 KB)
  • Annex I, Part 3: Template for Notification of Cosmetic Product (pdf, 232.58 KB)
  • Annex I, Part 4: Illustrative List for Types of Changes for Notified Product (pdf, 77.30 KB)
  • Annex I, Part 5: Guidelines for Product Information File (PIF) (pdf, 203.99 KB)
  • Annex I, Part 6: Guidelines for Safety Assessment of Cosmetic Product (pdf, 230.14 KB)
  • Annex 1, Part 7: Cosmetic Labeling Requirements (pdf, 33.83 KB)
  • Annex 1, Part 8: Cosmetic Claims Guidelines (pdf, 97.88 KB)
  • Annex 1, Part 9: Guidelines on Good Manufacturing Practice (GMP) for Cosmetic (pdf, 70.86 KB)
  • Annex 1, Part 10: List of Equivalent Cosmetic GMP Guidelines Recognized by ASEAN (pdf, 25.82 KB)
  • Annex 1, Part 11: Guide Manual for Adverse Event Reporting (pdf, 379.05 KB)
  • Annex 1, Part 12: Cosmetic Advertising Code (pdf, 29.05 KB)
  • Annexe II: List of Substances which Must Not Form Part of the Composition of Cosmetic Products (pdf, 641.65 KB)
  • Annexe III, Part 1: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down (pdf, 382.62 KB)
  • Annexe III, Part 2: List of Substances Provisionally Allowed (pdf, 32.48 KB)
  • Annexe IV: List of Colouring Agent Allowed for Use in Cosmetic Products (pdf, 66.98 KB)
  • Annexe V: List of Excluded from the Scope of the Directive (pdf, 13.25 KB)
  • Annexe VI: List of Preservatives which Cosmetic Products May Contain (pdf, 102.38 KB)
  • Annexe VII: List of UV Filters which Cosmetic Products May Contain (pdf, 30.21 KB)
  • Guidelines - Bioequivalent (BE)
  • ASEAN_BE_GUIDELINES_-Q_A_VERSION_4.pdf (pdf, 68.57 KB)
  • ASEAN_BE_Guidelines_-_Q_A_Version_3.pdf (pdf, 10.83 KB)
  • ASEAN BE Guidelines amended according to 1st BABE TWG15th PPWG (pdf, 242.82 KB)
  • ASEANGUIDELINESBE.pdf (pdf, 81.60 KB)
  • ASEAN BE Guidelines - Q & A (Version 2) (pdf, 67.18 KB)
  • ASEAN BE Guidelines - Q & A (Version 1) (pdf, 16.43 KB)
  • Bioequivalence Study Reporting Format (pdf, 36.66 KB)
  • ASEAN Guidelines for "The Conduct of Bioavailability and Bioequivalence Studies (pdf, 246.94 KB)
  • "The Conduct of Bioavailability and Bioequivalence Studies" (pdf, 84.51 KB)
  • Malaysian Guidelines for The Conduct of Bioavailability & Bioequivalence Studies (pdf, 84.51 KB)

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