China NMPA rolls out Drug Information Traceability System for key drug products

On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular …

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China Releases Technical Guidance for Using Real-World Evidence(RWE) to Support R&D and Regulatory Review of Pediatric Drugs (Interim)

The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and …

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China Publishes Policy paper on Five-Year Plan to Strengthen Adverse Event Monitoring System

Effective from 30 July 2020 onward, the National Medical Products Administration(NMPA) of China released a policy paper on its five-year …

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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 Adopts ICH E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER)

In order to strengthen the management of the life cycle of drugs and promote the international integration of drug regulatory …

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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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China Issues Specifications of Creating Periodic Risk Assessment Report for Medical Devices

The National Medical Product Administration (NPRA of China) has published specifications for creating a Periodic Assessment Report for Medical Devices(NO. …

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NMPA Releases Guidance Document for Chemical Drugs/Biological Products

National Medical Products Administration(NMPA) of China releases two guidances on drug registration categories for Chemical Drugs / Biologic Products and …

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