This kind of Chinese medicine companies paid attention to the new national policy on November 1st!

Next Monday, another Chinese medicine policy will be officially implemented!

On October 29, the State Food and Drug Administration issued the "Notice on Matters Concerning the Filing of Chinese Medicine Formula Granules" (Yao Jian Zong Yao Zhu [2021] No.

On February 10 this year, the State Food and Drug Administration announced the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" jointly issued by the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission and the National Medical Insurance Administration (No.

In order to strengthen the management of TCM formula granules and standardize the quality control and standard research of TCM formula granules, the State Food and Drug Administration also issued the "Technical Requirements for Quality Control and Standard Establishment of TCM Granules" with this announcement, which will be implemented from the date of publication

With the official promulgation of standards and management measures, this indicates that relevant pharmaceutical companies will usher in major benefits.

The “Announcement” of the State Food and Drug Administration stated that Chinese medicine formula granules shall not be sold outside of medical institutions, and the Chinese medicine formula granules used by medical institutions shall be purchased through the provincial centralized drug procurement platform Sunshine procurement and online transactions

Notice of the Comprehensive Department of the State Food and Drug Administration on matters related to the filing of traditional Chinese medicine formula granules

Drug Administration Comprehensive Drug Note (2021) No.

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 Drug 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.

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2.

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The processing and production process data, internal control drug standards and other data contained in the record content of Chinese medicine formula granules will not be disclosed

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If other information is to be changed, the corresponding filing information can be updated through the Chinese medicine formula granule filing module, and the filing number remains unchanged

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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
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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 the provisions of this notice, shall also comply with other relevant national regulations.
Regulations
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10.
Starting from November 1, 2021, Chinese medicine formula granules shall be produced in accordance with the provisions of the "Announcement"
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TCM formula granules produced by pilot enterprises of TCM formula particles before November 1, 2021 can be used in medical institutions filed by provincial drug supervision and administration departments as required, and each provincial drug supervision and administration department shall strengthen supervision
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11.
All provincial drug supervision and administration departments shall follow the principles of openness, fairness and impartiality 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 Fulfill the main responsibility and related obligations of the whole life cycle of the drug
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Hereby inform
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Comprehensive Department of State Food and Drug Administration

October 29, 2021

Note: The original text has been deleted