1. The application project should be a new chemical substance that has not been published at home and abroad.
2. The new compound must have certain physiological activity, and its pharmacodynamic test must fully prove that it has obvious advantages or characteristics compared with similar drugs at present.
3. The new compound must show high safety, and its preliminary toxicity (acute toxicity test) is lower than or equivalent to similar drugs. The result of mutation (Ames test) was negative.
4. Those who find new pharmacological activities of known compounds are given priority support. The number of funded projects shall not exceed 20% of the total number of projects.
5. The work has been accumulated or based, and the applicant and project team members have strong research ability and basic working conditions, and it is expected to achieve the expected results within three to five years. Chapter III Project Application and Evaluation Procedures Article 7 The applicant shall fill in the Application Form for New Drug Research Fund in state administration of traditional chinese medicine according to the prescribed content and format, and submit it to the Department of Science, Technology and Education of state administration of traditional chinese medicine in six copies after being examined and screened by the leaders and academic organizations of the unit, signing the specific examination opinions and affixing the official seal. The annual deadline for acceptance is the end of May. Article 8 The person in charge and main personnel of each project shall not apply for more than two projects at the same time. The person in charge of the project must be the worker who actually presides over and engages in the research of the applied project. Article 9 A new drug fund project shall hold an expert review meeting on the basis of inviting peer experts to review it. The expert review team consists of experts from relevant units all over the country. Members of the expert review team are selected and hired annually according to the categories of declared projects, and the fund projects are issued by state administration of traditional chinese medicine. Chapter IV Project Management Article 10 The starting and ending years of approved projects shall be counted from the following year 1 month. Conclude a contract with reference to China's technology contract law (the contract format shall be stipulated separately). Eleventh fund projects should be included in the scientific research plan of the undertaking unit. The undertaking unit shall be responsible for the completion of the project tasks and ensure the relative stability of the project leaders and members. Article 12 Research on new drugs involves many disciplines. In order to encourage cooperative research, the research funds required by the cooperators (units), the purpose of the funds allocated from the total funds approved by the applicant, and the obligations and achievements shared with the cooperators shall be determined by the corresponding contracts of both parties. Thirteenth approved scientific research project funds, a one-time examination and approval, annual appropriation. By the financial department of the unit to implement separate accounting, separate accounting, earmarking, the unit can extract no more than 5% of the management funds. When accepting funded projects, the completion status should be reported every year. If the project is not completed well, or the practice proves that the research should be stopped because of improper topic selection, the funding for the next year will be stopped after the research by both parties to the contract. Article 14 If the research is terminated without reason during the funding period, the balance shall be returned. Due to dereliction of duty, the applicant shall bear the risk compensation fee. If any objection is found to the project, the sponsor has the right to suspend funding until the problem is clarified. Fifteenth funded projects began in the same year, and the work progress was reported once a year in June. Submit a written report before 65438+February every year, including the project progress, achievements, the use of funds and the work plan for the next year. In order to strengthen project management and ensure the research quality, progress and reasonable use of funds, funders have the right to know the funded projects, observe the experiments when necessary, consult the records and provide suggestions. Sixteenth after the completion of all funded projects, it is necessary to summarize, write papers, identify (or comment), prepare final accounts of expenditures, and report the relevant information to state administration of traditional chinese medicine. Relevant technical information will be kept confidential. Chapter V Achievements and Awards Article 17 If the research achievements of new drugs (including phased achievements) are likely to be put into production and developed into new products, they shall not be published publicly in order to protect their rights and interests. If it belongs to the content that can be published, it is also necessary to negotiate with the funding unit and publish it on the premise of ensuring the patent rights and interests, and indicate the support of this fund at the end of the article. Article 18 When the research results funded by this Fund are developed into commodities and generate economic benefits (including patent transfer), the recipient unit shall repay the total amount of funding and give strong support to the New Drug Fund. The specific amount can be used to supplement the new drug funds to Party A after the new drug is approved for clinical use, so as to expand the financial capacity. Nineteenth innovative drug research achievements, to participate in the state administration of traditional chinese medicine bureau level awards, of which outstanding achievements will be recommended to apply for national awards.