Publications and guidelines

Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Second Edition, September 2016, Revised July 2018

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Step 3 of 4: Regulatory Outcome

11.0 REGULATORY OUTCOME 11.1 DECISIONS OF THE AUTHORITY A regulatory decision shall be made based on the outcome of the evaluation of the submitted documentation, and samples (if applicable). An…

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Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pengilang Farmaseutikal Bagi Tujuan Pendaftran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

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Direktif untuk melaksanakan guidelines on conditional registration for New Chemical Entities and Biologics

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Direktif Untuk Semua Produk Yang Mengandungi Prednisone Dan Prednisolone (Kecuali Persediaan Topikal): Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Scleroderma Renal Crisis.

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Direktif Untuk Semua Produk Yang Mengandungi Efavirenz: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan QTc Prolongation.

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Direktif Untuk Semua Produk Yang Mengandungi Doxycycline: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Jarisch-Herxheimer Reaction.

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Product Classification Guideline

1.2 Food - Drug Interphase Products 1.2.1 Introduction 1.2.2 Definition Of Food-Drug Interphase (FDI) Products 1.2.3 Classification For FDI Products 1.2.4 Negative List For FDI 1.2.5 General…

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Step 1 of 4: Pre-submission of Application (Preparation)

1.1. Apply QUEST 3+ Token To conduct transactions for product registration, variation, licensing, renewal and other related transactions, you must register your membership and purchase your digital…

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PEKELILING KRITERIA BARU PENGKELASAN PRODUK FOOD-DRUG INTERPHASE (FDI)

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Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplement

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QUEST User Manual

No. Document Name 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) Installation, Configuration & Troubleshooting 2 USER MANUAL QUEST 3+ Digital Certificate (USB Token) Using Google Chrome 3…

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Malaysia Comparator Product (MCP) for BE Study

The comparator products are listed according to pharmaceutical dosage form : Oral Solid, Modified Release Tablet/Capsule Oral Effervescent, Dispersible, Orodispersible, Sublingual, Lozenges, Buccal…

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User Manual

No. Document Name Download 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) - Using Mozilla Firefox : Installation, Configuration & Troubleshooting DOWNLOAD 2 USER MANUAL QUEST 3+ Digital…

Java Configuration

No. Document Name Download 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) - Using Mozilla Firefox : Installation, Configuration & Troubleshooting DOWNLOAD 2 USER MANUAL QUEST 3+ Digital…

Internet Browser for QUEST3+ System

Last update: 1st June 2021 As Browser versions are continuously updated, QUEST3+ System is only compatible with Browsers and Versions as mentioned below. In case you are unable to access QUEST…

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Proses Pendaftaran Pengguna Untuk Sistem Pendaftaran Produk & Perlesenan QUEST3+

Proses pendaftaran untuk Sistem Pendaftaran Produk & Perlesenan QUEST 3+ adalah amat mudah dan tidak memerlukan khidmat bantuan daripada agen/consultant* regulatori. Rujuk 5 LANGKAH MUDAH di bawah…

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User Manual

No. Document Name Download 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) - Using Mozilla Firefox : Installation, Configuration & Troubleshooting DOWNLOAD 2 USER MANUAL QUEST 3+ Digital…

Java Configuration

No. Document Name Download 1 USER MANUAL QUEST 3+ Digital Certificate (USB Token) - Using Mozilla Firefox : Installation, Configuration & Troubleshooting DOWNLOAD 2 USER MANUAL QUEST 3+ Digital…

Proses Pendaftaran Pengguna Untuk Sistem Pendaftaran Produk & Perlesenan QUEST3+

Proses pendaftaran untuk Sistem Pendaftaran Produk & Perlesenan QUEST 3+ adalah amat mudah dan tidak memerlukan khidmat bantuan daripada agen/consultant* regulatori. Rujuk 5 LANGKAH MUDAH di bawah…

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Direktif Mengenai Penerimaan Pengesahan Pematuhan Amalan Perkilangan Baik (APB) Bagi Pegilang Farmaseutikal Bagi Tujuan Pendaftaran Baru/ Pendaftaran Semula Produk Farmaseutikal Berdaftar Dengan Pihak Berkuasa Kawalan Dadah (PBKD)

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Direktif untuk semua produk yang mengandungi mesalazine: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan amaran kesan advers photosensitivity.

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New Publication: MADRAC Bulletin - Issue 3/2017

MADRAC Bulletin - Issue 03/2017 Safety Issues Presented to MADRAC in 2017 Regulatory Matters ▪ Fluconazole: Risk of Spontaneous Abortion and Multiple Congenital Abnormalities▪ Tramadol: Restricted…

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Direktif Kaji Semula Pendaftaran Produk untuk tujuan eksport sahaja/ For Export Only (FEO).

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Direktif penambahan kenyataan amaran bagi semua produk yang mengandungi Boswellia spp

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