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Release Date:2018/4/18 9:38:30
The general office of the General Administration of the people's Republic of China publicly solicited opinions on the administrative provisions on simplified registration and approval of traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft) and the requirements for application materials (Exposure Draft)
 
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Issued on October 9th, 2017
 

  In order to implement the law of the people's Republic of China on traditional Chinese medicine, the State Food and drug administration has organized the drafting of the administrative provisions on simplified registration and approval of traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft) and the requirements for application materials of standard decoction of traditional Chinese Medicine classic and famous prescription compound preparations and traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft), which are now open to the public for comments. Please feed back relevant opinions to the State Food and Drug Administration (drug and cosmetic Registration Administration) by email before October 31, 2017.

  Email: jingying@cfda.gov.cn

  Annex: 1. administrative provisions on simplified registration and approval of traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft)
     2. requirements for application materials of standard decoction of traditional Chinese medicine classic famous prescription compound preparation (Exposure Draft)
     3. requirements for application materials of traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft)
     4. drafting instructions for simplified registration and approval management provisions for traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft) and relevant application data requirements (Exposure Draft)


General Office of the State Food and Drug Administration
September 22, 2017

 

Annex 1. administrative provisions on simplified registration and approval of traditional Chinese medicine classic and famous prescription compound preparations.docx

Annex 2. requirements for application materials of standard decoction of classical and famous prescriptions of traditional Chinese medicine.docx

Annex 3. requirements for application materials of traditional Chinese medicine classic and famous prescription compound preparations (Exposure Draft).Docx

Annex 4. drafting instructions for simplified registration and approval management provisions for classical and famous prescription compound preparations of traditional Chinese medicine (Exposure Draft) and relevant application data requirements (Exposure Draft).Docx

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