Malaysia Updates Guideline for the Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption(CTX)

On August 2020, the NPRA of Malaysia has updated a document intended to guide the applicant in making Clinical Trial …

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China CDE Releases a Guideline on Non-Inferiority Clinical Trials for Drugs

Effective from 24 July 2020 onward, the Center for Drug Evaluation(CDE) of China releases a guideline on Non-Inferiority Clinical Trials …

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China Releases Working Procedures for Breakthrough Therapy Drugs, Conditional Approval and Priority Review

In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China …

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NMPA Issues Rules for Development Safety Update Reports(DSUR)

On 01 July 2020, China’s NMPA’s Center for  Drug Evaluation(CDE)  has issued administrative rules titled “Management Guidance/Standard for Development Safety …

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Japan Release Document on Clinical Evaluation of Pediatric Population along with Adults

03 June 2020, The Ministry of Health, Labour and Welfare (MHLW) of Japan released a document providing general guidelines for …

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Taiwan to Conduct GCP Inspection in Compliance with New Drug Applications

Taiwan Food and Drug Administration (FDA) published a guideline on 28 May 2020 to improve the efficiency of new drug …

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Taiwan Intends to Implement Inspection scheme for Bioequivalence Trial ( in 2021)

Towards an aim to ensure the quality and data management of bioequivalence study, the Taiwan Food and Drug Administration ( …

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NMPA Issues Guideline on Management and Archiving of Required Documentation for Drug Clinical Trials

The National Medical Products Administration (NMPA)  of China has released a circular as a guiding principle for the preservation of …

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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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