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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 MDA Med Dev Guidance: Guide for CABs and Medical Device Establishments

The Medical Device Authority (MDA) of Malaysia has released two important guidance documents, " Guide for Conformity Assessment Bodies...

Sharan Murugan

Apr 13 min read

Malaysia MDA Med Dev Guidance: Importation of Medical Devices for Re-Export (IRE)

The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...

Sharan Murugan

Mar 182 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's Medical Device Authority: Guideline on Medical Face Mask and Respirator

Recently (19 May, 2023) Medical Device Authority (MDA) of the Ministry of Health Malaysia released an updated guidance on "Medical Face...

Sharan Murugan

May 23, 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’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device

Malaysia’s Ministry of Health Medical Device Authority (MDA) division recently updated its "Guidelines on Classification of...

Sharan Murugan

Mar 14, 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

Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device

Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...

Sharan Murugan

Jan 19, 20231 min read

Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD

Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...

Sharan Murugan

Nov 27, 20221 min read

Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN

Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...

Sharan Murugan

Sep 7, 20221 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

Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA

Malaysia's Medical Device Authority (MDA) has drafted a guidance that will assist manufacturers and authorized representatives to...

Sharan Murugan

May 2, 20221 min read