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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China Releases Guidelines for Preparing Pharmacovigilance Outsourcing Agreement (Interim)

4 June 2020, The China National Centre for Adverse Drug Reaction (ADR) Monitoring releases guidelines applicable for drug marketing license …

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TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods

On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification …

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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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TGA Waives Pre-Approval for Medicine Advertisements in Specified Media

Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media. …

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TGA Waives Pre-Approval for Medicine Advertisements in Specified Media

Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media. …

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China to implement new Clinical Drug Quality Control Standards to harmonise GCP standards with ICH standards

In order to deepen the reform of the drug review and approval system, encourage innovation, and further promote the research …

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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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