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Pharmaceutical Network News on August 11 Encouraged by the national new drug innovation policy, more and more pharmaceutical companies are participating in new drug research and development, and the number of innovative drugs approved has increased significantly
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
Integrated top-level design of clinical research
According to the key nodes in the whole process of drug research and development, the integrated top-level design of new drug clinical research needs to consider the following aspects:
The first is the overall planning of pre-clinical research, which largely determines the clinical research strategy; the second is the connection of various links, including the connection of pre-clinical research and clinical research, and the connection between clinical trials; the third is various disciplines Coordination and communication with majors; fourth is the robustness and standardization of the management system; fifth is the efficient execution of team members
.
.
Clinical research operation control
Clinical research operation control is a means to ensure the implementation of the top-level design
.
.
Clinical trials are divided into 19 first-level links, 67 second-level links, and 134 third-level implementation links from the beginning of the topic, partner screening, ethical review, initiation and enrollment to the final submission of registration application materials
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
The three elements of clinical research operation management and control are schedule, cost, and quality.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
The prerequisite for progress control and clinical trials is to complete the application of the Genetics Office and obtain the approval documents from the Genetics Office
.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
Cost management and control Conventional cost management and control generally go through links such as resource allocation planning, preliminary cost estimation, cost budgeting, and cost control
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
Quality control The goal of quality control is to protect the rights and interests of subjects.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
Apply for listing
The continuous improvement of China's drug registration policies and application channels reflects the support and encouragement for the research and development of new drugs
.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
One is the conference system, including Type I, II, and III meetings
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
Pharmaceutical Network News on August 11 Encouraged by the national new drug innovation policy, more and more pharmaceutical companies are participating in new drug research and development, and the number of innovative drugs approved has increased significantly
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
Integrated top-level design of clinical research
According to the key nodes in the whole process of drug research and development, the integrated top-level design of new drug clinical research needs to consider the following aspects:
The first is the overall planning of pre-clinical research, which largely determines the clinical research strategy; the second is the connection of various links, including the connection of pre-clinical research and clinical research, and the connection between clinical trials; the third is various disciplines Coordination and communication with majors; fourth is the robustness and standardization of the management system; fifth is the efficient execution of team members
.
.
Clinical research operation control
Clinical research operation control is a means to ensure the implementation of the top-level design
.
.
Clinical trials are divided into 19 first-level links, 67 second-level links, and 134 third-level implementation links from the beginning of the topic, partner screening, ethical review, initiation and enrollment to the final submission of registration application materials
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
The three elements of clinical research operation management and control are schedule, cost, and quality.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
The prerequisite for progress control and clinical trials is to complete the application of the Genetics Office and obtain the approval documents from the Genetics Office
.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
Cost management and control Conventional cost management and control generally go through links such as resource allocation planning, preliminary cost estimation, cost budgeting, and cost control
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
Quality control The goal of quality control is to protect the rights and interests of subjects.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
Apply for listing
The continuous improvement of China's drug registration policies and application channels reflects the support and encouragement for the research and development of new drugs
.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
One is the conference system, including Type I, II, and III meetings
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
Pharmaceutical Network News on August 11 Encouraged by the national new drug innovation policy, more and more pharmaceutical companies are participating in new drug research and development, and the number of innovative drugs approved has increased significantly
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
.
It is particularly important to improve the success rate of clinical trials of new drugs, speed up the launch of new drugs, and do a good job in the integrated top-level design of new drug clinical research, operation management and control, and application for listing
.
Integrated top-level design of clinical research
Integrated top-level design of clinical research According to the key nodes in the whole process of drug research and development, the integrated top-level design of new drug clinical research needs to consider the following aspects:
The first is the overall planning of pre-clinical research, which largely determines the clinical research strategy; the second is the connection of various links, including the connection of pre-clinical research and clinical research, and the connection between clinical trials; the third is various disciplines Coordination and communication with majors; fourth is the robustness and standardization of the management system; fifth is the efficient execution of team members
.
.
Clinical research operation control
Clinical research operation control Clinical research operation control is a means to ensure the implementation of the top-level design
.
.
Clinical trials are divided into 19 first-level links, 67 second-level links, and 134 third-level implementation links from the beginning of the topic, partner screening, ethical review, initiation and enrollment to the final submission of registration application materials
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
.
To achieve high-quality and efficient management, it is necessary to formulate detailed project plans and divide different plan levels according to the process
.
The three elements of clinical research operation management and control are schedule, cost, and quality.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
Schedule refers to the progress of clinical trials from the beginning to the final approval; cost refers to the costs and resources invested; and quality refers to the completion of the results in accordance with science, The degree of ethics, norms and reporting requirements
.
The three are independent and closely related to each other, and need to be balanced and adjusted according to different stages
.
The prerequisite for progress control and clinical trials is to complete the application of the Genetics Office and obtain the approval documents from the Genetics Office
.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
Regulations and regulations.
At present, the regulations governing the application of the Genetics Office are the Regulations on the Management of Human Genetic Resources
.
The clinical trials of domestic innovative drugs usually involve "collection approval", "international cooperation approval/recording", "information provision or open use recording".
The content of concern is whether the number of clinical trials exceeds 500, whether the partner is involved in foreign investment or clinical trials.
generates information such as whether the exit
.
From project initiation, program design to the specific implementation of clinical trials, the entire process should consider the content of genetic resources
.
Cost management and control Conventional cost management and control generally go through links such as resource allocation planning, preliminary cost estimation, cost budgeting, and cost control
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
.
The key to cost control is to make a good cost budget, understand resources in advance, plan resources and achieve the best allocation of resources
.
Quality control The goal of quality control is to protect the rights and interests of subjects.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
It must follow the requirements of ethics, laws and regulations, and obtain true, standardized and complete clinical trial data
.
Corresponding systems and systems should be established, and training should be conducted on corresponding systems, systems, and test-related content
.
In addition, risk management should be done well, including risk identification, prevention and correction, and a rapid response and handling mechanism should be developed
.
Apply for listing
Apply for listingThe continuous improvement of China's drug registration policies and application channels reflects the support and encouragement for the research and development of new drugs
.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
Medicine, medicine, medicine.
At present, in accelerating the application and listing of new drugs, there are mainly the following supporting systems:
One is the conference system, including Type I, II, and III meetings
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
.
Class I meetings refer to meetings that are held when major safety issues are encountered in the process of drug clinical trials, and major technical issues are encountered in the development of breakthrough therapeutic drugs
.
Class Ⅱ meetings refer to meetings held at the critical stage of drug development, including pre-application meetings for new drug clinical trials; pre-application meetings for the end of phase Ⅱ clinical trials of new drugs/pre-initiation meetings for phase Ⅲ clinical trials; pre-application meetings for new drugs; risk assessment and control meetings, etc.
.
Type III meetings are other meetings except Type I and Type II meetings
.
The second is the four procedures, including breakthrough treatment drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures
.
(New Leading Medicine News Contribution)
