What are the requirements of the drug packaging regulations?
The pharmaceutical packaging regulations have the following requirements: 1. ** The packaging materials and containers that come into direct contact with drugs **: They must meet the medicinal requirements and meet the standards to protect human health and safety, and must be approved by the drug administration when approving the drugs. Pharmaceutical manufacturers are not allowed to use unapproved packaging materials and containers that come into direct contact with drugs. For unqualified packaging materials and containers that come into direct contact with drugs, the pharmaceutical supervisory and administrative departments shall order them to stop using them. 2. ** General requirements for drug packaging **: It must be suitable for the quality of drugs, convenient for storage, transportation, and medical use. Chinese medicinal herbs must be packaged before they are shipped. On each package, the name of the medicinal herb, the place of origin, the date, and the unit of transfer must be clearly indicated, as well as a symbol of qualified quality. 3. ** The label and instruction manual of the drug package **: The label and instruction manual must be printed or pasted according to the regulations. The label or instruction manual must indicate the common name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or main functions, usage, dosage, contraindications, adverse reactions, and precautions of the drug. The labels of anesthetics, psychotropics, toxic drugs for medical use, radioactive drugs, drugs for external use and non-prescription drugs must be printed with the prescribed symbols. 4. ** Regarding the classification management of pharmaceutical packaging materials **: For example, Class I pharmaceutical packaging materials refer to the packaging materials and containers for drugs that are in direct contact with drugs and used directly; Class III pharmaceutical packaging materials refer to the packaging materials and containers for drugs that may directly affect the quality of drugs other than Class I and II. 5. ** In terms of over-packaging of drugs **: The drug marketing authorization holder should reasonably design the packaging specifications according to the clinical symptoms, usage and dosage, and medication cycle, and reduce the packaging cost from the aspects of packaging layers, void ratio, material, outer packaging, etc. The packaging should be strictly in accordance with the approved inner packaging specifications of the drug, and the packaging specifications should not be changed without authorization. The relevant departments will strengthen the source of governance, strengthen supervision and inspection, and promote comprehensive measures to ensure the implementation of laws and regulations, including strict review of the filing of drug instructions, the filing of minimum sales unit packaging labels, and changes in packaging specifications. They will also carry out supervision and inspection on relevant enterprises, medical institutions, outpatients, and drugstores. Read more exciting novels for free
What are the requirements of the drug packaging regulations?
The contents of the drug packaging regulations are as follows: 1. As for the packaging materials and containers that come into direct contact with drugs, they must meet the medicinal requirements and meet the standards to ensure human health and safety. They must be approved by the drug supervision and administration department when approving the drugs. Drug manufacturers are not allowed to use unapproved materials. For unqualified packaging materials and containers, the drug supervision and administration department shall order them to stop using them. 2. The overall requirements for the packaging of drugs: It must be suitable for the quality requirements of drugs, and it must be convenient for storage, transportation, and medical use. Chinese medicinal herbs must be packaged for shipment, and each package must indicate the name, origin, date, transfer unit, and the quality qualification mark. 3. The requirements for the labels and instructions of the drug packaging: The labels and instructions must be printed or pasted according to the regulations. The label or instruction manual must indicate the common name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or functions, usage, dosage, contraindications, adverse reactions, and precautions of the drug. The labels of anesthetics, psychotropics, toxic drugs for medical use, radioactive drugs, drugs for external use and non-prescription drugs must be printed with the prescribed symbols. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the regulations for drug packaging?
China's Drug Administration Law has a special chapter on the packaging and sub-packaging of drugs to regulate the packaging of drugs. The following are the relevant provisions of the pharmaceutical packaging regulations: 1. For packaging materials and containers that come into direct contact with drugs: - The packaging materials and containers that come into direct contact with drugs must meet the requirements for medicinal use and meet the standards for ensuring human health and safety. They must also be approved by the drug supervision and administration department when approving the drugs. Drug manufacturers are not allowed to use unapproved packaging materials and containers that come into direct contact with drugs. For unqualified packaging materials and containers that come into direct contact with drugs, the drug supervision and administration department shall order them to stop using them. 2. The overall requirements for drug packaging: - The packaging of drugs must be suitable for the quality of drugs and convenient for storage, transportation and medical use. Chinese medicinal herbs must be packaged before they are shipped. On each package, the name of the medicinal herb, the place of origin, the date, and the unit of transfer must be clearly indicated, as well as a symbol of qualified quality. 3. The labels and instructions for the drug packaging: - The packaging of drugs must be printed or pasted with labels and instructions in accordance with regulations. The label or instruction manual must indicate the common name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or main functions, usage, dosage, contraindications, adverse reactions, and precautions of the drug. The labels of anesthetics, psychotropics, toxic drugs for medical use, radioactive drugs, drugs for external use and non-prescription drugs must be printed with the prescribed symbols. 4. Regarding the types of pharmaceutical packaging materials: - Class I pharmaceutical packaging materials refer to the packaging materials and containers for drugs that are in direct contact with drugs and used directly; Class III pharmaceutical packaging materials refer to the packaging materials and containers for drugs that may directly affect the quality of drugs other than Class I and II. The 2020 edition of the Chinese Pharmacopeia-General Rules for Pharmaceutical Materials and containers required that the pharmaceutical packaging materials should have good safety, adaptability, stability, functionality, protection and convenience. The selection and use of pharmaceutical plastic materials should match the type of container and the route of administration. Regenerated plastic should not be used, and the safety of the drug should be ensured. At the same time, pharmaceutical plastic containers needed to be tested for drug compatibility and chemical stability to ensure safety. The plastic materials used in medicine were classified in detail according to their functions, materials, shapes, structures, etc. Each type had its corresponding standards, such as YBB00012002 - 2015 Low-density Polythene infusion bottles, YBB00022002 - 2015 Polylene infusion bottles, etc. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the requirements and standards for pharmaceutical packaging regulations?
The pharmaceutical packaging regulations have the following requirements and standards: 1. ** Requirements for content printing ** - The packaging and labels of the drugs must be printed in accordance with the requirements stipulated by the State Drug Administration. The words and patterns must not be added with content that has not been approved, and the content must not exceed the content limited by the drug instructions approved by the State Drug Administration. - The description of the product on the packaging and label must be accurate and without error. In addition to describing the safe and reasonable use of drugs, there must not be any words and labels that do not properly promote the product, such as "National New Drug". - The trade name of the drug must be approved before it can be used on the packaging and label. The trade name cannot be written in conjunction with the common name and should be written separately. After the trade name is registered, it must still comply with the management principles. The ratio of the common name to the trade name should not be less than 1:2 (referring to the area). The font size of the common name should be consistent and not bracketed. A registered trademark that has not been approved for use as a trade name may be printed on the upper left corner or upper right corner of the packaging label, and the font must not be larger than the common name. 2. ** Requirements for format compatibility ** - For the same enterprise, the same drugs of the same specifications (referring to the drug specifications and packaging specifications), the packaging, label format and color must be consistent, and different brands must not be used. If the same variety of the same enterprise has different specifications, the packaging and labels of the smallest sales unit should be clearly different or the specifications should be clearly marked. 3. ** Min sales unit requirement ** - The smallest sales unit of a drug refers to the smallest package of a drug that is directly available for marketing. The packaging of each smallest sales unit must be printed with a label and attached with an instruction manual. 4. ** Requirements for special drug labels ** - For anesthetics, psychotropics, toxic drugs for medical use, radioactive drugs, and other drugs under special management, drugs for external use, and over-the-counter drugs, a mark that conforms to the regulations must be printed on the large package, medium package, the smallest sales unit, and the label. For drugs that have special requirements for storage, a clear indication must be made on the packaging and the label. 5. ** Requirements for the packaging of imported drugs ** - In addition to the above provisions, the packaging and labels of imported drugs should also be marked with the "Registration Certificate No. of imported drugs" or "Registration Certificate No. of pharmaceutical products", the name of the manufacturer, etc.; the packaging and labels of imported subpackaged drugs should be marked with the name of the original manufacturer or region, the production date, the batch number, the validity period, and the name of the domestic subpackaged enterprise, etc. 6. ** Requirements for the packaging of drugs produced and commissioned for processing in other places ** - For drugs approved to be produced in other places, the packaging and labels shall also indicate the name of the group, the manufacturer, and the place of production; for drugs approved to be commissioned for processing, the packaging and labels shall also indicate the name of the entrusting parties and the place of processing. 7. ** Text Usage Requirements ** - For drugs sold and used in China, the packaging and labels must be mainly in Chinese and use the current standard language published by the State Language and Character Work Committee. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the requirements and regulations for the latest drug research and development regulations?
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 traditional Chinese medicine, establish and improve the technical evaluation system that conforms to the characteristics of traditional Chinese medicine, promote the inheritance and innovation of traditional Chinese medicine, take effective measures to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that conform to the physiological characteristics of children, and give priority to the review and approval of children's drugs. Those engaged in drug research and development activities should abide by the quality management standards for non-clinical research and clinical trials of drugs, and ensure that the entire process of drug research and development continues to meet the legal requirements. To carry out non-clinical research on drugs, there must be personnel, sites, equipment, instruments, and management systems suitable for the research project to ensure the authenticity of relevant data, materials, and samples. To carry out clinical trials of drugs, relevant data, materials and samples such as research and development methods, quality indicators, pharmacology and toxicity test results shall be submitted truthfully in accordance with the regulations and approved. It shall also be carried out in a clinical trial institution with corresponding conditions, and the institution shall implement filing management. The development of drug clinical trials must conform to ethical principles. The clinical trial protocol must be reviewed and approved by the ethics committee. The purpose and risks of the clinical trial must be truthfully explained to the subjects or their guardians, and the informed consent form must be obtained and their legal rights and interests must be protected. During the clinical trial of a drug, if safety problems or other risks are found, the clinical trial sponsor shall promptly adjust, suspend or terminate the clinical trial and report it. If necessary, the drug administration department may order the adjustment, suspension or termination of the clinical trial. 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. For drugs listed in China, the drug registration certificate should be approved by the drug supervision and administration department (except for the Chinese medicinal materials and Chinese herbal slices that have not been approved and managed). The application for registration should provide data, information and samples that prove the safety, effectiveness and quality control of the drug. The drug administration department shall organize personnel to review the drugs applied for registration, and issue the drug registration certificate to those who pass the review. During the review and approval, the chemical raw materials shall be reviewed and approved at the same time, and the relevant auxiliary materials, packaging materials and containers that come into direct contact with the drugs shall be reviewed and approved at the same time. The quality standards, production process, labels and instructions of the drugs shall be reviewed and approved at the same time. 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. Drug supervision and administration departments should improve the drug review and approval work system, strengthen capacity building, establish and improve communication, expert consultation and other mechanisms, and improve the review and approval process to improve the review and approval efficiency. In accordance with ICHQ10, establish a pharmaceutical quality system including research and development, regulate technology transfer and its processes and work content at each stage; carry out the development and production of bulk drugs in accordance with ICHQ11, including identifying potential key quality attributes of bulk drugs, determining a suitable manufacturing process, material attributes and the relationship between process parameters and key quality attributes of bulk drugs, identifying potential factors of process changes, determining critical decision trees and design space, etc. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the regulations for drug development?
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>
What regulations does excessive packaging violate? Why?
Over-packaging violated the product quality law, food safety law, solid waste pollution prevention law, consumer rights protection law, price law and other laws and regulations. According to the Law on the prevention and control of environmental pollution by solid waste, producers and operators were obliged to abide by the mandatory standards that restricted the over-packaging of goods to avoid over-packaging, because over-packaging would produce more solid waste and increase the pressure on the environment. Over-packaging would cause too many layers of packaging and too high a void ratio in the packaging, which would exceed the basic functions of packaging protection and beautification of the product. This was a waste of resources and did not meet the requirements of resource conservation and environmental protection, so it was subject to relevant legal constraints. From the perspective of the consumer protection law, excessive packaging could mislead consumers. For example, consumers might pay extra for excessive packaging without getting the actual value of the goods. In terms of the Price Law, if excessive packaging led to unreasonable price composition, such as the high cost of packaging that affected the overall price of the product, it was also not in compliance with the regulations. As for food and cosmetics, their production and operation must also follow the "Restriction of excessive packaging of goods, requirements for food and cosmetics".(GB 23350 - 2021), which stipulated the requirements, testing and judgment rules to limit the excessive packaging of food and cosmetics. If it was violated, it may be punished for violating relevant laws and regulations. For fresh edible agricultural products, the "Restriction of Over-packaging of Goods and Requirements for Fresh Edible Agricultural products" implemented since April 1,2024 also provides a basis for enforcement. Production and operation enterprises shall comply with the requirements of moderate and reasonable packaging, while excessive packaging violates this regulation. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
Are there any regulations on drug safety management?
Are there any drug safety management regulations? <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the requirements for the inner packaging style of drugs?
The inner packaging of drugs should be able to ensure the quality of drugs during production, transportation, storage and use, and should be convenient for medical use. The name, specifications and production batch number of the drug must be indicated on the inner packaging. At the same time, the inner label of the drug in the inner packaging should include the common name of the drug, indication or function, specifications, dosage, production date, product batch number, expiration date, manufacturer, etc. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the environmental requirements for the packaging of the medicine box?
The environmental requirements for the packaging of the medicine box were mainly reflected in the following aspects: 1. ** Material Selection **: - It was required that the packaging materials should be made of degraded and recycled materials as much as possible. This will help reduce the environmental pollution caused by packaging waste and promote environmental protection and sustainable development. 2. ** Reduction **: - Under the premise of ensuring the quality and safety of the medicine, the amount of packaging materials should be reduced as much as possible. This would help reduce resource consumption and production costs, achieving a win-win situation for both economic and environmental benefits. For example, the first national drug packaging reduction standard stipulated that the number of packaging layers should be less than or equal to three layers, and the void ratio of the packaging should be limited according to the different drug content, etc. Consider adjusting the medium packaging form that is widely used in the market at present, and replace the traditional paper box by wrapping film and plastic bag to realize the reduction of packaging materials. Choose cardboard boxes that meet the needs of various storage environments such as cold storage and room temperature, instead of the traditional cardboard box model and size "one-size-fits-all" packaging method, and transport drugs in a more scientific, reasonable, and economical way. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>
What are the contents of the drug research phase regulations?
Drug development mainly had the following stages and relevant regulations: - ** Pre-clinical research stage **: Mainly includes the discovery and screening of new active ingredients, and the development of pharmacology and toxicity experiments (safety evaluation tests). - ** New drug clinical trial phase **: - ** Phase I clinical trial **: It is a preliminary clinical pharmacology and human safety evaluation test to observe the human body's tolerance to the new drug and its pharmacology, and to provide a basis for the formulation of the drug administration plan. The number of cases is 20 - 30. - ** Phase II clinical trial **: It is the preliminary evaluation stage of the treatment effect. The purpose is to preliminary evaluate the treatment effect and safety of the drug on patients with the target indication. It also includes providing a basis for the design of the phase III clinical trial and the determination of the dosage plan. The research design can be in various forms, such as a random blind controlled clinical trial. The number of cases should not be less than 100. - ** Phase III clinical trial **: It is the confirmation stage of the treatment effect. The purpose is to further verify the treatment effect and safety of the drug for patients with the target indication, evaluate the relationship between benefits and risks, and finally provide sufficient evidence for the review of the drug registration application. The trial should generally be a random, blind, controlled trial with sufficient sample size. According to the requirements of different diseases and dosage forms, the number of cases should not be less than 300. - ** Phase IV clinical trial **: It is the application research stage after the new drug is launched. The purpose is to investigate the efficacy and adverse reactions of the drug under widespread use conditions, evaluate the relationship between benefits and risks of using it in general or special populations, and improve the dosage. The number of cases shall not be less than 2000. - ** Bioequivalent test **: It refers to a human trial that uses the method of the study of the bio-utilization to compare the preparations of the same or different dosage forms of the same drug. Under the same test conditions, the degree and speed of absorption of the active ingredients are compared. Generally, 18 - 24 cases are involved. Generally, the development of a generic-type drug requires a bioequivalent test. - ** Production and post-marketing research phase **: The commercial production of drugs should comply with the Good Drug Production Practice, and the clinical use of drugs in the research and development phase should comply with the Good Drug clinical Trial Practice. During the R & D process, stability studies were carried out throughout the entire stage. It was necessary to follow relevant domestic and international regulations, such as ChP2020 <9001 Guidance on the stability testing of drug substances and preparations>, ChP2020 <9402 Guidance on the stability testing of biological products>, ICHQ1A-Q1E, relevant regulations of the World Health Organization, and 211.166 Stability testing of the Food and Drug Administration. <a href="/?from=ask_words" style="color:red" target="_blank">Read more exciting novels for free</a>