Inventory of laws and regulations and industry practices for the fresh-cut processing industry chain

With the promulgation of the "Drug Administration Law" revised in 2019, the National Bureau of China and various provincial bureaus have begun a new round of restructuring of the drug administration system

Part 1: Summary of supporting documents issued by the state and provincial bureaus

So far, the State Food and Drug Administration and various provincial bureaus have issued a number of regulations and policies related to cutting while they are fresh, which are summarized as follows:

Part Two: The current catalog of pilot varieties in various provinces

Up to now, many provincial drug regulatory bureaus have released medicinal materials that can be cut fresh, summarized as follows:

Part 3: Regulatory requirements for cutting Chinese herbal medicines while they are fresh

According to the State Administration’s "Reply from the Comprehensive Department of the State Drug Administration on the Issues Concerning the Purchasing of Chinese Herbal Medicines Produced by Manufacturers of Chinese Herbal Medicines Produced from the Place of Origin" condition:

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Part IV: Regulatory requirements of traditional Chinese medicine companies for suppliers of medicinal materials

As a purchaser, whether the company is a Chinese medicine preparation company or a Chinese medicine decoction company, if you want to purchase fresh-cut Chinese medicinal materials, you should actively perform your duties

First, the purchaser must sign a perfect agreement with the company engaged in the fresh-cutting system

Second, the purchaser needs to conduct the initial audit and follow-up audit of the production enterprise, and urge the other party to establish a quality system and continue to maintain and improve it

Third, the purchaser needs to establish acceptance criteria for medicinal materials and form complete documents

Fourth, for some medicinal materials with special storage and transportation conditions, both the purchaser and the manufacturer need to actively strengthen management

Summarize

As China's pharmaceutical policy reform continues to deepen and expand, it is believed that the State Administration will actively listen to industry opinions and adopt reasonable management measures in many areas of pharmaceutical management

references

1-NMPA official website

2- Official website of each provincial bureau