In order to promote the development of science and technology of drugs and medical devices, better meet the people's needs in disease prevention, treatment, rehabilitation, health care and family planning, correctly evaluate the level of medical scientific and technological achievements, improve the appraisal system of scientific and technological achievements, strengthen the management of scientific and technological achievements, and promote the application and popularization of scientific and technological achievements, these administrative measures are formulated according to the appraisal method of scientific and technological achievements of the State Science and Technology Commission and the actual situation of the pharmaceutical industry. Article 2 Classification of scientific and technological achievements:
(1) Scientific theoretical achievements: refers to the research achievements of basic medical theories and applied theories.
(2) Applied research achievements: refers to new products, new technologies, new processes, new materials, new designs, new equipment and other medical scientific and technological achievements that are novel, advanced and practical.
(3) Soft science research achievements: refer to soft science research achievements that promote scientific decision-making and management modernization in the pharmaceutical industry. Article 3 Scientific and technological achievements that must be appraised:
(a) the key projects of medical science and technology and the annual plan of medical science and technology issued by the State Planning Commission, the State Science and Technology Commission and the State Administration of Medicine.
(2) Medical scientific and technological achievements applying for scientific and technological awards, that is, projects applying for the National Natural Science Award, the National Invention Award, the National Science and Technology Progress Award and the Science and Technology Progress Award of the State Administration of Medicine.
(3) medical science and technology projects issued by the provinces (autonomous regions and municipalities), the Municipal Science and Technology Commission and the Pharmaceutical Administration (the head office) and projects applying for provincial and municipal science and technology awards.
(four) other medical science and technology projects that should be identified according to the relevant provisions of the state. Fourth scientific and technological achievements appraisal form:
(1) Testing and appraisal: Any project whose technical level and maturity can be determined through laboratory tests and tests can be tested, tested and evaluated by professional testing institutions according to national standards, industry standards or relevant technical indicators, and a written conclusion can be made;
(2) Acceptance appraisal: the acceptance unit conducts acceptance, evaluation and draws a written conclusion according to the planned tasks or the acceptance standards and methods stipulated in the contract;
(3) Communication appraisal: peer experts review and evaluate the relevant technical data of scientific and technological achievements in written form, and organize appraisal units to summarize and draw conclusions;
(4) conference appraisal: for scientific and technological achievements that involve a wide range, have a significant impact on the national economy and greatly promote the technical level of the industry, experts can be convened to conduct conference appraisal, and the experts will review and evaluate the achievements and draw conclusions. Article 5 Appraisal shall be regarded as:
(a) has been applied in production practice, which proves that the technology is mature and has achieved economic and social benefits, and the certificate is issued by the practice unit.
(two) according to the provisions of the contract to complete the task, and acceptance, after the implementation of economic and social benefits, and by the implementation of the unit issued a certificate.
(3) A production method that has obtained the invention patent of China Patent Office, achieved economic and social benefits after implementation, and has a certificate issued by the implementing unit. Sixth scientific and technological achievements appraisal management:
(1) state administration of traditional chinese medicine Science and Education Department is responsible for the appraisal of medical scientific and technological achievements in this department.
The science and technology department of the provincial (autonomous regions and municipalities) drug administration (head office) is responsible for the appraisal of medical scientific and technological achievements in this province (autonomous regions and municipalities).
(2) Identification and classification management:
Where the State Science and Technology Commission, the State Planning Commission, state administration of traditional chinese medicine's planned projects, by the state administration of traditional chinese medicine Science and Education Department or entrust the relevant units for identification.
Provincial (district, city) level planning projects by the provincial (district, city) drug administration (head office) is responsible for organizing the identification or entrust the relevant units to organize the identification.
Other projects that do not belong to the national and provincial (autonomous regions and municipalities) level plans shall be identified by the grass-roots units included in the plan with reference to these measures. If some of these projects make breakthrough progress, which is of great significance to the country and industry, such achievements may also be submitted to the higher authorities for identification. Article 7 Ownership of scientific and technological achievements:
The order of the units and main researchers who have completed the achievements should be arranged according to their creative contributions to scientific and technological achievements. When there is a dispute over ownership, it should be identified after the dispute is resolved. Eighth scientific and technological achievements appraisal procedures:
(1) Preparation of evaluation data:
1. Technical contract, plan task book, special demonstration report and plan completion.
2 research reports, experimental reports, clinical reports (use reports), academic papers, and related design technical charts.
3. Technical index test report and quality standard.
4. Comparative data of domestic and foreign research and investigation data of patent status.
5. The analysis or proof of economic benefit or social benefit, and the theoretical research results should provide the cited situation after the publication of the paper.
6. others.
(2) Application for appraisal:
Fill in the appraisal application form with relevant appraisal materials, and apply to the organization appraisal unit at least 2 months before appraisal.
(3) Appraisal and approval:
After receiving the appraisal application, the organization appraisal unit shall carefully review the submitted materials, and reply to the applicant appraisal unit on whether or not to agree with the appraisal, appraisal form, appraisal committee list (or consulting appraisal experts list) and other related matters within 1 month.
(four) consulting, evaluation experts and appraisal committee:
1. In the inspection and acceptance appraisal, a small number of experts can be hired for consultation and appraisal.
2. An appraisal committee of 5- 13 people can be organized for meeting appraisal. Scientific research personnel who have completed the results shall not participate in the appraisal committee, and the personnel who have completed the results shall not participate in the appraisal committee for more than a quarter, and those who have nothing to do with the appraisal content shall not attend the meeting.
3. Requirements for consulting and evaluation experts and members of the evaluation committee: they should have senior and intermediate professional titles in their respective industries or fields; Have a high academic and technical level and rich practical experience; Have a good professional ethics.
4. Rights and obligations of consulting experts and members of appraisal committees: the appraisal of scientific and technological achievements should adhere to the principles of seeking truth from facts, being serious and practicing economy; Experts and members have the right to fully express their personal opinions; Have the right to ask those who have completed their grades to reply; Have the right to request repeated testing. After full discussion, the minority obeys the majority to pass the appraisal conclusion and sign the appraisal book. If you have any objection, you have the right to indicate it in the appraisal book. Experts and members have the obligation to keep the appraisal results confidential.
(5) Identification contents:
1. Scientific value of the results: including the evaluation of the purpose and significance of the results; Whether the arguments and arguments of the results are clear; Whether the data is accurate, etc.
2. Academic level and technical level of the achievement: including the innovative evaluation of the achievement compared with domestic and foreign patent and non-patent documents; The academic significance and technical level of this achievement.
3. Technical maturity: including whether the technical data are complete; Whether to complete the task as originally planned; Advantages, disadvantages and suggestions for improvement of this achievement.
4. Economic rationality: including whether the achievement promotion scheme is feasible and whether the social and economic benefits are reliable; Whether there is a financial certificate of the implementing unit; Whether it pollutes the environment, whether the three wastes treatment scheme is feasible, etc.
5. Confidentiality of the results: According to state administration of traditional chinese medicine's Measures for the Administration of Science and Technology Confidentiality, the applicant shall declare the confidentiality by himself, and report it to the appraisal department after discussion by the appraisal committee.
(six) issued an appraisal certificate:
Fill in the appraisal certificate (or deemed appraisal certificate) of scientific and technological achievements issued by the State Science and Technology Commission, which will be compiled and issued by the organization appraisal department in a unified way, and verify the classification of the achievements according to the relevant confidentiality provisions.
Organize the appraisal unit to carefully review the appraisal report and related materials, and approve and issue the appraisal certificate to those who are qualified; There are major defects, which can be supplemented by the appraisal committee or consulting experts. Those that do not meet the requirements have the right to refuse.
(7) Remuneration for technical consultation: The appraisal applicant may pay the technical consultation fee to the consulting experts or members of the appraisal committee according to the specific conditions of the department and unit.
The evaluation method of medical devices shall be implemented in accordance with the relevant provisions on the management of new medical devices.