Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Malaysia’s NPRA Guidance: Drug Registration Guidance, What’s Inside?

On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the " Drug...

Sharan Murugan

Jul 232 min read

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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