新闻动态
News Information
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- Solicit the drug approval for examination and approval administration of the general office of publi
The review report mainly covers basic information of registration applications, comprehensive review opinions, technical review conclusions and post-marketing risk control requirements.
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- Jinping hosted a deep reorganization meeting examined and approved the "about reform and improve the
He stressed that in 2018, is to implement the party's 19 of the great spirit, also is the 40th anniversary of reform and opening up, to do a good job of reform is of great significance.
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- The FDA declared licensing process and requirements of biological products
Product/manufacturing information. v. side effects; The 2002 revision of the PDUFA requires that the standard review of new drug applications be completed within a 10-month timeframe.
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- Adjust the acceptance for drug registration announcement administration
Applicants for drug registration may choose to submit the application materials by post or on-site, and encourage drug registration applicants to submit the application materials by mail.
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- Therapeutic biological products latest registration classification
On October 23, 2017, CFDA issued the revised measures for the administration of drug registration (revised version). Category 4: domestic listed biological products.
