Notice of the comprehensive Department of the State Food and Drug Administration on matters related

Yjzyz [2021] No. 94
The drug administration of all provinces, autonomous regions and municipalities directly under the central government and the drug administration of Xinjiang production and Construction Corps:
In accordance with the announcement of the State Food and drug administration, the State Administration of traditional Chinese medicine, the State Health Commission and the State Medical Insurance Bureau on ending the pilot work of traditional Chinese medicine formula granules (No. 22 of 2021) (hereinafter referred to as the announcement), in order to standardize the variety filing management of traditional Chinese medicine formula granules and ensure the smooth and orderly filing work, the relevant matters are hereby notified as follows:
1、 From November 1, 2021, the varieties of traditional Chinese medicine formula granules shall be subject to filing management. Before listing for sale, it shall, in accordance with the relevant provisions of the announcement, go through the "online service hall of the State Drug Administration"（ https://zwfw.nmpa.gov.cn/ ）"Drug business application system - traditional Chinese medicine formula granule filing module" for filing, and obtain the filing number. For the user registration process, refer to the announcement of the State Food and Drug Administration on Online Declaration of drug registration (No. 145 in 2020).
2、 The format of the filing number obtained by the traditional Chinese medicine formula granules in the place where the manufacturer is located is: listing preparation word + 2-digit provincial location code + 2-digit year number + 6-digit sequence number + 3-digit change sequence number (the 3-digit change sequence number for the first filing is 000); The format of the filing number obtained for cross provincial sales is: cross provincial prepared word + 2-digit provincial location code + 2-digit year number + 6-digit sequence number + 3-digit change sequence number (the 3-digit change sequence number for the first filing is 000).
3、 The filing materials of traditional Chinese medicine formula granules shall be submitted in accordance with the filling instructions in the filing module of traditional Chinese medicine formula granules, and the authenticity, integrity and traceability of the filing materials shall be guaranteed.
4、 Each provincial drug regulatory department shall uniformly publish relevant information on the website of the State Drug Administration for public inquiry within 5 days from the date of generation of the record number. The information includes: name, manufacturer, production address, filing number, filing time, specification, packaging specification, shelf life, executive standard of traditional Chinese medicine formula granules, executive standard of traditional Chinese medicine decoction pieces, adverse reaction monitoring information (if any), etc.
The processing and production process data, internal control drug standards and other data in the filing contents of traditional Chinese medicine formula granules shall not be made public.
5、 The filing information of traditional Chinese medicine formula granules shall not be changed at will. If the recorded traditional Chinese medicine formula granules involve the production process (including auxiliary materials), quality standards, packaging materials, production address and other information affecting the quality of traditional Chinese medicine formula granules, they shall be reported to the provincial drug supervision and administration department where the traditional Chinese medicine formula granule production enterprise is located for the record according to the above procedures and requirements. After the filing is completed, the filing number of traditional Chinese medicine formula granules is automatically updated.
If other information is to be changed, the corresponding filing information can be updated through the filing module of traditional Chinese medicine formula granules, and the filing number remains unchanged.
6、 The annual report shall be implemented in the next year after obtaining the filing number, and shall be submitted through the filing module of traditional Chinese medicine formula granules before March 31 of each year.
7、 Each provincial drug regulatory department shall complete the review of the recorded varieties within 30 days after the announcement of the record, and organize on-site verification and inspection when necessary. The filing data of the varieties of traditional Chinese medicine formula granules can be used for the supervision and inspection and extended inspection of drug regulatory departments.
8、 If any of the following circumstances is found in the supervision and inspection, the provincial drug regulatory department shall cancel the filing and disclose the relevant information in the filing module of traditional Chinese medicine formula granules:
（1） The filing materials are untrue;
（2） The filing materials are inconsistent with the actual production and sales;
（3） The production license of the production enterprise is revoked, revoked or cancelled according to law;
（4） The filing person applies for cancellation of the filing;
（5） Failing to pass the examination after filing;
（6） There are serious quality and safety risks;
（7） Other circumstances under which the filing should be cancelled according to law.
9、 The filing of traditional Chinese medicine formula granules involving endangered wild animals and plants, toxic drugs for medical use, narcotic drugs, psychotropic drugs and pharmaceutical precursor chemicals shall not only be handled in accordance with the provisions of this circular, but also comply with other relevant provisions of the state.
10、 From November 1, 2021, traditional Chinese medicine formula granules shall be produced in accordance with the provisions of the announcement. The traditional Chinese medicine formula granules produced by the pilot enterprises of traditional Chinese medicine formula granules before November 1, 2021 can be used in the medical institutions filed by the provincial drug supervision and administration departments according to regulations, and the provincial drug supervision and administration departments shall strengthen supervision.
11、 Each provincial drug regulatory department shall follow the principles of openness, fairness and impartiality in the filing of traditional Chinese medicine formula particles, strengthen communication with enterprises, guide enterprises to carry out filing, provide convenient, high-quality and efficient services, and urge enterprises to fulfill their main responsibilities and relevant obligations throughout the life cycle of drugs.
It is hereby notified.
Comprehensive Department of State Food and Drug Administration
October 29, 2021