Pharmacy and Poisons Board of Hong Kong has issued 5 New Guidances for Advanced Therapy Products 

In June 2021, The Pharmacy and Poisons Board of Hong Kong issued 5 new guidances for Advanced Therapy Products. These guidances will be effective in August …

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HSA Singapore Issues Updated Version of Regulatory Requirements For Clinical Trial New Applications And Subsequent Submissions

The new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances.   …

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South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics

South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official …

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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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