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ARQon
Jan 132 min read
Malaysia: NPRA’s New Protocol Assessment and Testing Procedure for Registered Vaccine Products
The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of...
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ARQon
Dec 26, 20242 min read
Malaysia: NPRA's Transition to Remote GDP Inspections (w.e.f. 18 December 2024)
The National Pharmaceutical Regulatory Agency (NPRA) has introduced a progressive initiative to improve the regulatory process for...
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ARQon
Nov 27, 20242 min read
Malaysia: NPRA Bans Chloroform and Chloroform Spirit as Preservatives (w.e.f. 19 November 2024)
Effective 19 November 2024 , the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the...
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ARQon
Sep 25, 20241 min read
Malaysia: NPRA Updates Drug Labeling Requirements for Animal-Derived Ingredients
The National Pharmaceutical Regulatory Agency (NPRA) recently released an update of the Drug Registration Guidance Document (DGRD) to...
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ARQon
Jun 18, 20241 min read
Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit Registration
The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...
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ARQon
Jun 11, 20242 min read
Malaysia: MDA Implements One License Per Establishment Role Policy (w.e.f 1 July 2024)
Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...
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ARQon
May 14, 20241 min read
Malaysia: Navigating Trade Barriers for Medical Devices in Nations without Diplomatic Ties
Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...
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