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  1. www.npra.gov.my › index › enRegulation Basic - National Pharmaceutical Regulatory Agency (...

    Regulation Basics. NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed. A system to monitor products in the market was set-up.

  2. www.npra.gov.my › index › enCosmetic Main Page - National Pharmaceutical Regulatory Agency...

    Jun 19, 2024 · The CNH is required to COMPLY with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant ...

  3. www.npra.gov.my › index › enGuideline for Pharmacovigilance - National Pharmaceutical...

    Jun 28, 2024 · Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection (1st Edition, March 2022) 29 March 2022. Hits: 11352. 4.4 : Post-Marketing Activities. 13 March 2019. Hits: 40521. Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021) 30 September 2021.

  4. www.npra.gov.my › index › myNational Pharmaceutical Regulatory Agency (NPRA) - Halaman Utama

    Industri. Pendaftaran Produk, Sistem QUEST3+, Garis Panduan, Borang Permohonan, FAQs. National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Malaysia Drug Control Authority.

  5. www.npra.gov.my › index › en3.0 Regulatory Requirements For Cosmetics - NPRA

    Nov 25, 2021 · 3.1 Product Particulars. CNH is required to submit the following information during the notification process: 3.1.1 Particulars of product including product name, product type, intended use and product presentation. 3.1.2 Name and address of the manufacturer (s) and assembler (s), if any. 3.1.3 Name, address and valid contact number (and e-mail ...

  6. www.npra.gov.my › index › enGuidelines for Natural Products - National Pharmaceutical...

    Jun 28, 2024 · Hits: 7580. DRGD Appendix 7A - Guideline on Registration of Homeopathic Products. 29 December 2021. Hits: 5148. Malaysian Variation Guideline for Natural ( Traditional Medicine & Homeopathy ) and Health Supplement Product 2016. 19 July 2016. Hits: 25697. National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia.

  7. www.npra.gov.my › index › enProduct Registration Process - National Pharmaceutical Regulatory...

    Jun 28, 2024 · ICH - The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. CTD - Common Technical Document . 4.2.2. GMP certificate status. Local Manufacturer - Issued by National Pharmaceutical Regulatory Agency (NPRA) as stated in Drug Regulation Guidance Document (DRGD) Note to follow for international ...