Recently，stake online sports bettingThe State Drug Administration released the "Story of Simplified Registration Approval Management Regulations"，Conditions for simplified approval、Applicant Qualification、Declaration and release of material benchmark、Registration procedures and management requirements of classic famous preparations、The responsibilities of all parties have been explained in detail。

Ancient classic famous Chinese medicine compound preparations simplified registration approval management regulations

Article 1 is the development of traditional Chinese medicine for inheritance，Strengthen the quality management of ancient classic famous Chinese medicine compound preparations (hereinafter referred to as classic famous prescriptions)，Formulate these regulations in accordance with the "Drug Administration Law of the People's Republic of China" and "Chinese Medicine Law of the People's Republic of China"。

Article 2 For the ancient classic celebrities that originated from the state announced in the state, and the non -market varieties (except for the varieties that have been simplified for registration and approval in accordance with these regulations)，Comply with the requirements of this regulation，Implementation of simplified approval。

Article 3 The implementation of the classic famous preparations of registered approval shall meet the following conditions:

(1) The prescription does not include compatible taboos or drug standards.

(2) The traditional Chinese medicine flavor and the medicinal materials involved have national drug standards;

(3) The preparation method is basically the same as the ancient medical records;

(4) Except for soup, it can be made into a particle agent，The dosage form should be consistent with the ancient medical records;

(5) The way of administration is consistent with ancient medical records，Daily drinking amount is equivalent to ancient medical records;

(6) Function and Indications should stake betting appadopt Chinese medicine terms，stake betting appBasically consistent with ancient medical records;

(7) The scope of application does not include infectious diseases，No pregnant woman、Special medications such as infants and young children。

Article 4 Registered applicants (hereinafter referred to as applicants) of the classic famous preparations shall be established in accordance with the law in China，Pharmaceutical manufacturers that can independently bear the responsibility of drug quality and safety，and should meet the requirements of national industrial policy。

Production enterprises shall have the production of Chinese medicine drinks、Extraction、Concentration、Dry、Preparation and other complete production capacity，Requirements to the quality management specifications of drug production。

Article 5 Classic famous preparations that meet the requirements of Article 3 apply for listing，It can only provide pharmacy and non -clinical safety research information，Reported Pharmacy Research and Clinical Test Information。The applicant should ensure that the data of the declaration information is true、Full、traceable。

Article 6 The development of the "Classic Fame Material Standards" and the development of preparation development。The applicant should be published in accordance with the prescription announced by the ancient classic famous party catalog、The development of the "Classic Material Standards"，Study on the research of classic famous preparations in accordance with the "Classic Material Standards"，Prove that the key quality attributes of the classic famous preparation are consistent with the key quality attributes determined by the "Classic Material Standards"。

"Classic Fame material benchmark"，refers，Except for the formation process，The remaining preparation methods should be basically the same as the ancient medical records。

7 The applicant submits a registration application for the procedure for the listing of the classic famous preparations。Apply for the listing of the corresponding "classic famous material benchmark" in the National Drug Administration，You can only submit the reporting information related to the "classic famous material benchmark"，And supplemented the relevant declaration materials for submitting the classic famous preparations after the "Classic Material Standards" was released。A review of the "Classic Material Standards" is not calculated within the time limit of review。The applicant can extend the time limit for supplementary information due to research needs，At the same time, explain the reason to the drug review agency of stake online sports bettingThe State Drug Administration。

Apply for listing after publishing the corresponding "classic famous material benchmark" in stake online sports bettingThe State Drug Administration，It shall submit a complete registration application information at one time in accordance with Article 5 of these regulations。

My stake betting appArticle 8 Before applying for the listing of classic stake betting appfamous square preparations，Drug review agencies of stake online sports bettingThe State Drug Administration can arrange to communicate with the applicant at a meeting，​​Specifications on the relevant information of the "Classic Fame Material Standards" and other opinions and suggestions。The applicant shall modify it based on the results of communication、Improve the declaration information。

9 The Drug Review Agency of stake online sports bettingThe State Drug Administration will be within 5 days after receiving the relevant information of the "Classic Material Standards" submitted by the first applicant，The list of applicants should be announced on its website，The publicity period is 6 months。During the publicity period，Other applicants can continue to submit a self -developed "Classic Material Standards" related information for the listing procedures，The list of applicants will be announced together。

After the publicity period is over，The Organization of the Drug Review Institutions of stake online sports bettingThe State Drug Administration organized experts to review the "Classic Material Standards"，and listen to the applicant's opinion，Forms a unified standard for "Classic Material Standards" (hereinafter referred to as unified standards)。After review，The "Classic Material Standards" submitted by the applicant does not meet the requirements，Drug review agencies of the State Drug Administration can allow other applicants to continue to submit relevant information about the "classic name material benchmark"。

Article 10 Drug review agencies of stake online sports bettingThe State Drug Administration shall publicize the unified standard of review (3 months of publicity period，Not calculated within the time limit of review)。After the publicity period is over，Drug review agencies of the State Drug Administration based on the collected feedback，Organization applicant、Experts revise this standard，The unified standard after the review is released on the release of the State Drug Administration。

Encourage the applicant to participate in the research of the "Classic Material Standards"、Draft and enjoy results，Name of the drafting unit in the uniform standard published。

Article 11 After the application information of the Drug Review Agency of stake online sports bettingThe State Drug Administration received a classic famous preparation application，It should be organized for pharmacy、Medical and toxicology and technical personnel review the application information，If necessary, you can ask the applicant to supplement the information，Explain the reason。

Article 12 The Drug Review Agency of stake online sports bettingThe State Drug Administration starts the development site inspection and production site inspection，and notify the National Drug Administration's drug inspection agency。Drug Inspection Institutions of the State Drug Administration organized the development of on -site inspections and production site inspections。Drug review agencies of the State Drug Administration based on technical review opinions、Research on -site inspection report、Sample production site inspection report and sample inspection results，Form comprehensive opinions，Also reported to the State Drug Administration。The State Drug Administration is based on comprehensive stake sports betting appopinions，Make an approval decision。

The review of the review does not meet the requirements，The Drug Review Agency of stake online sports bettingThe State Drug Administration will submit review opinions and relevant information to the State Drug Administration，The State Drug Administration is based on technical review opinions，Make a decision not to be approved，issued to the "Notice of Approval Opinions"，Explain the reason。

Article 13 The production enterprise of classic famous preparations shall be used for the medicinal materials used、Quality of Drinks and Accessories，Preparation production、Sales delivery、Bad reaction report、The traceability system is responsible。

Article 14 The production process of classic famous preparations shall be consistent with the approval process，and ensure the continuous stability and compliance of the production process。Production enterprises shall cooperate with the supervision of the drug supervision and management department，Inspection of the implementation of the drug supervision and management department is cooperated with it，Do not refuse、Escape、Procrastination or obstruction。

Article 15 The formulation of the drug standard of classic famous preparations，Study on a comparison with the "Classic Fame Material Standards"，Fully consider at the source of medicinal materials、Drinking film production、Factors that affect quality in various aspects such as preparation production and use，Systems develop medicinal materials、Drink、Intermediate、The quality of the real objects and preparations corresponding to the "classic famous material benchmark"，Consider its correlation，and determine the key quality attribute，Create the corresponding quality evaluation index and evaluation method，Determine the scientific and reasonable drug standard。Strengthen the differential identification and multi -ingredients、Overall quality control。

Production enterprises should formulate strict internal control drug standards，Measures to clearly control the quality control of the entire process according to the key quality attribute、Key quality control points and related quality requirements。Enterprise internal control standards must not be lower than the drug registration standard。

Article 16 The drug name of the classic famous preparation should be the same as the name of the prescriptions in ancient medical citizens。

Article 17 Drugs in the classic famous preparation must explain the specific source of prescriptions and functional governance; indicate the daily dose of the prescription medicine flavor; it is clear that this product is only used as prescription drugs for clinical use of Chinese medicine。

Article 18 of the classic stake betting appfamous square preparations，Production enterprises shall carry out monitoring of drug adverse reactions in accordance with national drug adverse reactions，and report to the drug supervision and management department stake online sports bettingto report the drug adverse reactions occurred during the use of drugs，Risk control measures，Revised instructions in time。

Article 19 Drug production enterprises shall sell drug production and sales、Clinical use、Adverse reaction monitoring、The annual summary results of the changes and resource assessment of the drug and the relevant instructions of stake online sports bettingThe State Drug Administration of Drug Review Agency。

Article 20，Can't fulfill continuous examination of drug quality、Classic Famous Family Preparations of the curative effect and adverse reaction responsibility，Drug Supervision and Administration Department does not approve it to register again，The approval number is canceled after expiration。

Article 21 The listing approval of the classic famous preparations except for the implementation of simplified approval in accordance with these regulations，Acceptance of the declaration information、On -site inspection of the development of the development and original information、Production site inspection、Drug Registration Inspection、Sample inspection and relevant registration management requirements for changes after the classic famous preparations are listed，Implement in accordance with relevant national regulations。

Article 22 The provisions shall be implemented from the date of release.