Ye Mianmian's novel

In China, the regulations related to drug research and development were as follows: - The state supports the innovation of drugs that are oriented to clinical value and have clear or special effects on human diseases. It also supports the development of new drugs with new treatment mechanisms, treatment of serious life-threatening diseases or rare diseases, and multi-targeted systematic regulation and intervention functions for the human body, so as to promote the advancement of pharmaceutical technology. We should encourage the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of Chinese medicine, establish and improve a technical evaluation system that conforms to the characteristics of Chinese medicine, promote the inheritance and innovation of Chinese medicine, and take effective measures to encourage the development and innovation of children's drugs. - Those engaged in drug research and development activities should abide by the quality management regulations for non-clinical research and the quality management regulations for clinical trials of drugs to ensure that the whole process of drug research and development continues to meet the legal requirements. These two regulations were formulated by the drug supervision and administration department under the State Council in conjunction with the relevant departments under the State Council. - To carry out non-clinical studies of drugs, it is necessary to comply with the relevant national regulations, have personnel, sites, equipment, instruments, and management systems that are suitable for the research project, and ensure the authenticity of relevant data, information, and samples. - To carry out clinical trials of drugs, the research methods, quality indicators, pharmacology and toxicity test results and other data, materials and samples shall be truthfully submitted and approved according to the regulations of the drug supervisory and administrative department under the State Council. Among them, the drug administration department of the State Council shall decide whether to agree and notify the sponsor within 60 working days from the date of acceptance of the clinical trial application. Failure to notify the sponsor within the time limit shall be deemed as consent. If the bioequivalent trial is carried out, it shall be reported to the drug administration department of the State Council for filing. Drug clinical trials should be carried out in clinical trial institutions that meet the corresponding conditions. Drug clinical trial institutions shall be subject to filing management. The specific measures shall be jointly formulated by the drug administration department under the State Council and the competent health department under the State Council. - The clinical trial of drugs must be carried out in accordance with ethical principles, and the clinical trial plan must be formulated and approved by the ethics committee. The ethics committee should establish a working system to ensure that the review process is independent, objective, and fair, supervise the implementation of drug clinical trials, protect the legitimate rights and interests of the subjects, and safeguard the public interest. To conduct a clinical trial of a drug, it is necessary to truthfully explain the purpose and risks of the clinical trial to the subject or his guardian, obtain the informed consent form signed voluntarily, and take effective measures to protect the legitimate rights and interests of the subject. - During the clinical trial of a drug, if safety problems or other risks are found, the clinical trial sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the drug administration department of the State Council. When necessary, the drug administration department under the State Council may order the adjustment, suspension or termination of clinical trials. - For drugs that are undergoing clinical trials to treat serious life-threatening diseases that have no effective treatment methods, if they may benefit from medical observation and conform to ethical principles, they can be used on other patients with the same condition in the institution where the clinical trial is conducted after review and informed consent. - Except for the Chinese herbal medicines and Chinese herbal slices that have not been approved and managed, the drugs listed in China should be approved by the drug supervision and administration department of the State Council and obtain the drug registration certificate. To apply for drug registration, one should provide true, sufficient and reliable data, information and samples to prove the safety, effectiveness and quality control of the drug. - For the drugs applied for registration, the drug supervision and administration department of the State Council would organize pharmaceutical, medical and other technical personnel to review the safety, effectiveness, and quality control of the drugs, as well as the quality management, risk prevention and control, and responsibility compensation of the applicants. If the conditions were met, a drug registration certificate would be issued. When approving drugs, the chemical raw materials, relevant auxiliary materials, packaging materials and containers that come into direct contact with the drugs shall be reviewed and approved together. The quality standards, production process, labels and instructions of the drugs shall be reviewed and approved together. - For the treatment of diseases that are seriously life-threatening and have no effective treatment methods, as well as drugs that are urgently needed in public health, if the clinical trials of the drugs have shown the efficacy and can predict their clinical value, they can be approved with conditions, and the relevant matters can be stated in the drug registration certificate. - The drug supervision and administration department under the State Council should improve the drug review and approval work system, strengthen capacity building, establish and improve communication and expert consultation mechanisms, improve the review and approval process, and improve the review and approval efficiency. The review conclusion and basis for the approval of drugs for marketing shall be made public according to law and subject to social supervision. In terms of industry management system: - As the drug supervision department, the State Drug Administration (NMPA) and its branches were responsible for the administrative management and technical supervision of the research, production, circulation and use of drugs. NMPA was mainly responsible for drug safety supervision and management, drafting supervision and management policy planning, drafting laws and regulations, drafting department rules and supervising their implementation, researching and formulating management and service policies to encourage new drug technologies and new products, responsible for drug standard management, registration management, quality management and post-marketing risk management, formulating inspection systems and organizing and guiding drug supervision and inspection. The Food and Drug Inspection Center of the State Food and Drug Administration was mainly responsible for organizing the formulation and revision of drug inspection system specifications and technical documents, and was responsible for drug clinical trials, qualification certification (certification) of non-clinical research institutions, on-site inspection of research and development, and on-site inspection of drug registration. The Center for Drug Evaluation of the State Drug Administration (CDe) is mainly responsible for the acceptance and technical review of drug clinical trials and drug marketing authorization applications, as well as the technical review of the evaluation of the quality and efficacy of generics. It also takes part in the formulation of relevant laws, regulations and standardized documents for drug registration management, as well as organizing the formulation of drug review specifications and technical guidelines, as well as organizing the implementation and coordination of inspections and tests related to drug review. - Our country implements self-discipline management for the production and operation of scientific research and technical service industries. The systems related to the Crow industry include the national drug standard system, the drug registration management system, the drug marketing authorization holder system, and the consistent evaluation system. - National drug standard system: National drug standards are mandatory technical guidelines and legal basis that must be followed in all aspects of drugs. Its system is based on the Drug Standard of the Ministry of Health of the People's Republic of China and the Chinese Pharmacopeias, the Drug Administration Law and the Administrative Methods for Drug Registration as the foundation, and the standards issued by the bureau/ministry as the extension. The Pharmacopeias Committee organized by the Drug Administration Department of the State Council is responsible for formulation and revision. - Drug registration management system: The State Food and Drug Administration/State Administration for Market Supervision and Administration will review the safety, effectiveness, and quality control of the drugs to be sold in accordance with the legal procedures according to the application of the drug registration applicants and decide whether to approve the application. Drug registration management follows the principles of publicity, fairness, and fairness. It is guided by clinical value, encouraging research and creation of new drugs, and actively promoting the development of generics. The relevant departments shall publish the list of drug registration and approval items, the basis, the approval requirements, and the time limit for handling according to law. They shall publicize the progress of drug registration, the review conclusions and basis for approving the drugs for marketing, as well as the illegal behaviors discovered in the supervision and inspection, and accept social supervision. In addition, there are clear regulations on the classification of chemical registration and the requirements for application materials. - Pharmaceutical Marketing Authority Holders (MAH): Pharmaceutical marketing authorization holders refer to the enterprises or pharmaceutical research and development institutions that have obtained the drug registration certificate. They shall be responsible for the non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring, reporting and handling of drugs in accordance with the regulations. Other relevant units and individuals shall bear corresponding responsibilities according to law. Under the MAH system, the marketing authorization and manufacturing authorization were independent of each other. The marketing authorization holder could be a variety of entities and could entrust the product to different manufacturers for production. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>

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