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Malaysia’s NPRA: Drug Registration Guidance Document (DRGD), 3rd Edition, Ninth Revision January 2025
Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The " Drug Registration Guidance...
Sharan Murugan
Jan 262 min read
39 views
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Malaysia’s NPRA: Guidance for Bioequivalence Inspection
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence...
Sharan Murugan
Sep 25, 20242 min read
34 views
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Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
Sharan Murugan
May 25, 20242 min read
68 views
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Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial...
Sharan Murugan
Mar 29, 20242 min read
60 views
0 comments
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...
Sharan Murugan
Dec 19, 20231 min read
53 views
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Malaysia NPRA: Guidance on Drug Registration
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration"...
Sharan Murugan
Jul 30, 20232 min read
255 views
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Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
Sharan Murugan
Jul 12, 20231 min read
125 views
0 comments
Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...
Sharan Murugan
Apr 18, 20231 min read
71 views
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Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
Sharan Murugan
Mar 11, 20231 min read
148 views
1 comment
MALAYSIAN (NPRA): VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in...
Sharan Murugan
Jul 27, 20222 min read
299 views
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Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...
Sharan Murugan
Jun 16, 20221 min read
18 views
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Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA
On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...
Sharan Murugan
Apr 6, 20221 min read
11 views
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Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...
Sharan Murugan
Nov 7, 20211 min read
12 views
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Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has released guidance about the requirements and procedures of good...
Sharan Murugan
Sep 8, 20212 min read
317 views
0 comments
Malaysia release GUIDANCE on "FOREIGN GMP INSPECTION"- NPRA
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices...
Sharan Murugan
Aug 25, 20211 min read
150 views
0 comments