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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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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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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EPD Hong Kong Issues Guideline for Unserviceable / Expired Medicines

On May 2020, The Environmental Department (EPD)  of Hong Kong has published a guideline with procedures on disposing of unserviceable …

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TGA Australia Updates Regulatory Guidelines In Replacement of ARGCM V8.0

The Therapeutic Goods Administration (TGA) of Australia has published in May 2020, new guidelines to replace the existing Australian Regulatory …

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China Issues Three Technical Guidelines for Consistency Evaluation of Generic Chemical Injections

On 15 May 2020, the Drug Evaluation Centre of China (CDE) has issued guidelines used to evaluate the consistency of …

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