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China – Revised proposed on Provisions for Lot Release of Biological Products

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China – Revised proposed Provisions for Lot Release of Biological Products

China Food and Drug Administration has notified a revision to Provisions for Lot Release of Biological Products, issued in 2004. It includes 7 chapters, 49 articles. It specifies that vaccines, blood products and blood screening agents should be subject to quality assessment such as mandatory examination and inspection by quality control laboratories of drugs designated by CFDA. And only the qualified ones can be imported to and/or distributed in China. Main changes in this revision include: adding a chapter of lot Release institutes, defining the time-limit of the whole chain and the situation under which on-site inspection shall be conducted.

Proposed date of adoption: 1 July 2017

Proposed date of entry into force: To be determined

Final date for comments: 60 days after circulation by the WTO Secretariat

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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