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Sharan Murugan
Sep 25, 20242 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...
29 views0 comments
Sharan Murugan
May 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...
47 views0 comments
Sharan Murugan
Mar 29, 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...
42 views0 comments
Sharan Murugan
Dec 19, 20231 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...
47 views0 comments
Sharan Murugan
Jul 30, 20232 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"...
194 views0 comments
Sharan Murugan
Jul 12, 20231 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...
113 views0 comments
Sharan Murugan
May 23, 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...
18 views0 comments
Sharan Murugan
Apr 18, 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...
67 views0 comments
Sharan Murugan
Mar 14, 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...
39 views0 comments
Sharan Murugan
Mar 11, 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...
138 views1 comment
Sharan Murugan
Jan 19, 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...
41 views0 comments
Sharan Murugan
Nov 27, 20221 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...
17 views0 comments
Sharan Murugan
Sep 7, 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...
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Sharan Murugan
Jul 27, 20222 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...
280 views0 comments
Sharan Murugan
Jun 16, 20221 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...
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Sharan Murugan
May 2, 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...
17 views0 comments
Sharan Murugan
Apr 24, 20221 min read
Malaysia’s MDA- Draft Medical Device Labeling Guidance
The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth...
8 views0 comments
Sharan Murugan
Apr 17, 20221 min read
Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA
This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...
11 views0 comments
Sharan Murugan
Apr 6, 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"...
10 views0 comments
Sharan Murugan
Mar 23, 20221 min read
Malaysia Draft Medical Device Guidance on PERSONAL PROTECTIVE EQUIPMENT (PPE) - REQUIREMENTS
The Malaysian Medical Device Authority (MDA) drafted a guideline on personal protective equipment (PPE) and seeks feedback from the...
6 views0 comments