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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NMPA of China Releases Chinese Pharmacopoeia 2020

Upon the review and approval of the plenary meeting of 11th Pharmacopoeia Commission Executive Committee, China’s National Medical Products Administration …

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China Publishes Guidance for Medical Device Good Manufacturing Practice On-Site Inspections on Standalone Software

On 29 May 2020, the National Medical Products Administration ( NMPA) of China has formulated a  “Guiding Principles for On-site …

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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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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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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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NMPA of China Releases Evaluation Guideline for Raw Material Changes in Passive Medical Devices

On 19 May 2020, the National Medical Products Administration(NMPA) of China has formulated a document to evaluate the changes in …

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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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China NMPA Releases “Adverse Event Reporting Guidance for Medical Device Registrants”

On 03 April 2020, the NMPA of China has recently issued Guidelines for Medical Device Registrants to carry out adverse …

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