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  1. www.npra.gov.my › index › enGuidelines - National Pharmaceutical Regulatory Agency (NPRA)

    National Pharmaceutical Regulatory Agency (NPRA) Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. Phone: +603-7883 5400

  2. www.npra.gov.my › index › enCosmetics Guideline ( Annex I - VII )

    Dec 9, 2022 · Find the latest guidelines for control of cosmetic products in Malaysia, including categories, safety, labeling, claims, advertising, and more. Download the updated documents and check the list of substances, colors, preservatives, and UV filters allowed or restricted for cosmetics.

  3. www.npra.gov.my › index › enNCE Guidelines - National Pharmaceutical Regulatory Agency (NPRA)

    Sep 30, 2018 · Malaysian Guidelines on Good Pharmacovigilance Pratices (GVP) for Product Registration Holders (1st Edition, August 2021) 2021-09-30. Direktif untuk semua produk yang mengandungi Ceftriaxone: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko encephalopathy 2021-06-14.

  4. pink.citeline.com › - › mediaDRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)

    Drug Registration Guidance Document (DRGD) Third Edition, Third Revision July 2022 Bahagian Regulatori Farmasi Negara (NPRA) Page 2 of 63 GUIDELINE HISTORY No. Guideline Description of Amendment Effective date 1. a) Guidelines for Application for Registration of Pharmaceutical Products, Third Edition b) Permohonan Pendaftaran

  5. www.pharmatomarket.com › npra-malaysia-issues-updatedNPRA Malaysia Issues Updated Guidelines for Pharmacovigilance

    National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021. The updated guidelines are: “Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, August 2021” (effective from the 1st of January 2022).

  6. portal.mda.gov.my › index › documentsGUIDELINE FOR REGISTRATION OF DRUG-MEDICAL DEVICE AND MEDICAL...

    This present guideline serves as guidance for the submission of registration application of drug-medical device/ medical device-drug combination products, and change/variation application.

  7. pharmacy.moh.gov.my › en › organisasiBahagian Regulatori Farmasi Negara (NPRA) | Pharmaceutical...

    46200 Petaling Jaya, Selangor. [ Location map] Phone: 603-7841 3200. Fax: 603-7968 2222. You are here. Home. National Pharmaceutical Regulatory Agency (NPRA) Disclaimer : Pharmaceutical Services Programme, Ministry of Health Malaysia shall not be liable for any loss or damage resulting from the use of information in this portal.