Policy Frontier丨Notice of the Comprehensive Department of the State Drug
Administration on Matters Concerning the Filing of Chinese Medicine Formula
Granules.
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 National Medical Products
Administration, National Administration of Traditional Chinese Medicine,
National Health Commission, and National Medical Insurance Administration on
Ending the Pilot Work of Chinese Medicine Formula Granules" (No. 22 of 2021)
(hereinafter referred to as the "Announcement"), it is a standard for the
varieties of Chinese medicine formula granules Filing management to ensure the
smooth and orderly development of filing work, the relevant matters are hereby
notified as follows:
1. Starting from November 1, 2021, the varieties of Chinese medicine formula
granules will be subject to record management. Before going on the market, it
should be approved in accordance with the relevant provisions of the
"Announcement" through the "National Medical Products Administration Online
Service Hall" (https://zwfw.nmpa.gov.cn/) "Pharmaceutical Business Application
System-Traditional Chinese Medicine Formula Granule Recording Module" Record and
obtain the record number. For the user registration process, please refer to the
"Announcement of the State Drug Administration on Drug Registration Online
Application" (No. 145 of 2020).
2. The format of the record number obtained by the Chinese medicine formula
granule at the location of its production enterprise is: listing record + 2
digit provincial location code + 2 digit year number + 6 digit sequence number +
3 digit change sequence number (3 digit change sequence for the first record The
number is 000); the format of the record number obtained for cross-provincial
sales use is: cross-provincial record word + 2-digit provincial location code +
2-digit year number + 6-digit sequence number + 3-digit change sequence number
(3 digit change sequence for the first record The number 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,
completeness and traceability of the filing materials shall be guaranteed.
4. The provincial drug regulatory authorities shall publish relevant
information on the website of the State Drug Administration within 5 days from
the date of the creation of the record number for public inquiries. The
information includes: name of TCM formula granules, manufacturer, production
address, record number and record time, specifications, packaging
specifications, shelf life, TCM formula granules execution standards, TCM
decoction pieces execution standards, adverse reaction monitoring information
(if any), etc.
The processing and production process data, internal control drug standards
and other data in the contents of the Chinese medicine formula granules record
will not be made public.
5. The filing information of traditional Chinese medicine formula granules
shall not be changed at will. For the registered Chinese medicine formula
granules, if the information that affects the quality of Chinese medicine
formula granules, such as the production process (including excipients), quality
standards, packaging materials, production address, etc., is planned to be
changed, it shall be reported to the province where the Chinese medicine formula
granule manufacturer is located in accordance with the above procedures and
requirements. Grade-level drug supervision and administration department for the
record. After the filing is completed, the filing number of the traditional
Chinese medicine formula granules is automatically updated.
If other information is planned to be changed, the corresponding filing
information can be updated through the Chinese medicine formula granule filing
module, and the filing number remains unchanged.
6. The annual report shall be implemented in the next year after obtaining
the record number, and shall be submitted through the Chinese medicine formula
granule record module before March 31 of each year.
7. Each provincial drug regulatory authority shall complete the review of the
registered varieties within 30 days after the filing is announced, and organize
on-site inspections and inspections when necessary. The filing data of the
varieties of Chinese medicine formula granules can be used for supervision and
inspection and extended inspection by the drug supervision and management
department.
8. If one of the following situations is found during the supervision and
inspection, the provincial drug supervision and administration department shall
cancel the record and disclose relevant information in the record module of
Chinese medicine formula granules:
(1) The filing materials are untrue;
(2) The filing materials are inconsistent with the actual production and
sales situation;
(3) The production license of the production enterprise has been revoked,
revoked, or cancelled according to law;
(4) The filing person applies for cancellation of filing;
(5) The review fails after filing;
(6) There are serious quality and safety risks;
(7) Other circumstances in which filing should be cancelled in accordance
with the law.
9. The filing of traditional Chinese medicine formula particles involving
endangered wild animals and plants, toxic drugs for medical use, narcotic drugs,
psychotropic drugs, and pharmaceutical precursor chemicals, in addition to being
handled in accordance with the provisions of this notice, shall also comply with
other relevant national regulations. Regulation.
10. Starting from November 1, 2021, Chinese medicine formula granules shall
be produced in accordance with the provisions of the "Announcement". TCM formula
granules produced by pilot enterprises of TCM formula granules before November
1, 2021 can be used in medical institutions filed by the provincial drug
supervision and administration departments in accordance with regulations, and
each provincial drug supervision and administration department shall strengthen
supervision.
11. All provincial drug supervision and administration departments shall
follow the principles of openness, fairness and justice in the filing of Chinese
medicine formula granules, strengthen communication with enterprises, guide
enterprises to carry out filing, provide convenient, high-quality and efficient
services, and supervise enterprises Perform the main responsibility and related
obligations of the drug throughout the life cycle.
hereby notify.
Comprehensive Department of State Food and Drug Administration
October 29, 2021