Malaysia Implements Evaluation of Bioequivalence (BE) Examination Requirements

On  2 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has agreed to the implementation evaluation of bioequivalence …

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Malaysia Issues Document for GMP Inspections on Traditional Medicines, Health Supplements and Cosmetics Manufacturers

On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) …

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Malaysia Publishes Guidance Document for Medical Device Distribution Records

On June 2020, Medical Device Authority (MDA) of Malaysia has published a guidance document to set a framework for the …

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Malaysia Issues Circular on Transition Period for Medical Device Advertisement

On 20 May 2020,  the Medical Device Authority (MDA) of Malaysia has issued a circular pertaining to the transition period …

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Malaysia Issues Guidance Documents on Complaint Handling and Mandatory Problem Reporting for Medical Devices

In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act …

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NPRA of Malaysia Implements Fast-Track Review for Clinical Trials

On 18 June 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has published a circular announcing a fast-track review …

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NPRA of Malaysia Issues Directive on Pre -Registration Test Results of Natural Products

On 12 May 2020. National Pharmaceutical Regulatory Division (NPRA) has issued a directive by the Director of Services Pharmacy pertaining …

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Malaysia Issues Directive for Physical Testing for Lot Release Activities for Vaccine and Plasma Products

On 12 May 2020,  the National Pharmaceutical Regulatory Division (NPRA) of Malaysia  has announced a directive by the Director of …

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Malaysia Issues New Guideline for Obsolete and Discontinued Medical Device

The Medical Device Authority (MDA) of Malaysia has recently issued a guidance document on 16 April 2020 for industry and …

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