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Category: China Pharma RA

China issues revised drug administration law on August 26th, 2019

2019-08-282019-08-29 jmedtec0

On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001. In the updated drug law, the concept of marketing authorization holder…

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China News, China Pharma RA, News, Resources

ICH Guidelines adopted in China (Continually Updated)

2019-03-19 jmedtec0
China Pharma RA, Resources

China Drug Regulation Summary

2018-08-24 jmedtec0
China Pharma RA, Resources

CFDA: Guidelines for Acceptance of Overseas Clinical Trial Data

2018-01-232018-05-17 jmedtec0

CFDA Announcement No. 13 in 2018, Issued on Jan. 18, 2018 Outline: To fulfill the clinical need of public for medical devices, improve the innovation of medical device technology, this guideline is made according to the “Opinions on reforming the review…

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China Pharma RA, Resources1 Comment on CFDA: Guidelines for Acceptance of Overseas Clinical Trial Data

Recent Posts

  • China Ministry of Science and Technology gives full support to the development and approval of rapid assay of Novel Coronavirus (2019-nCoV)
  • Approval of medical devices and IVDs within two weeks during the coronavirus emergency
  • China allows overseas medical devices import without registration into the country due to the coronavirus emergency
  • Some hospitals in the Greater Bay Area in China may exempt from the China NMPA registration for use the drug and medical devices registered in Hong Kong SAR
  • Booming Healthcare Sector at the 2nd China International Import Expo (CIIE) held in Shanghai

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