-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Medical News, July 22, recently, the IVD industry innovation and development seminar sponsored by the Tianjin Medical Products Administration and China Health Media Group and sponsored by China Medical News was held in Tianjin.
This conference is Tianjin’s 2021 “National Medical One of the theme activities of "Device Safety Promotion Week"
.
At the meeting, relevant persons, experts and scholars from regulatory agencies, medical institutions and enterprises conducted in-depth discussions and suggested high-quality development of the IVD (in vitro diagnostic) industry
.
The seminar attracted a large audience, and the meeting room was packed
.
Policies to stimulate the vitality of the IVD industry
On June 1, the newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the newly revised Regulations) were formally implemented
.
Article 8 of the newly revised "Regulations" clearly stipulates that the state formulates medical device industry plans and policies, incorporates medical device innovation into the development focus, prioritizes the review and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes medical devices High-quality development of the industry
.
"The newly revised "Regulations" newly added relevant content to encourage and support medical device innovation, which fully reflects the state's requirements for encouraging the innovative development of medical devices and promoting the high-quality development of medical devices
.
" Registration Division I, Medical Device Registration Management Department, State Drug Administration Zhao Yang, a Level 4 researcher, said at the meeting .
Zhao Yang introduced that in order to further encourage the innovation and development of the medical device industry, the "Regulations" were revised to establish a medical device registrant and recorder system; new regulations on medical device registration and filing can submit self-inspection reports; new medical device emergency use system ; new medical research reagent management systems .
It is worth mentioning that in recent years, with the continuous deepening of China's medical device review and approval system reform, the continuous innovation of the regulatory system, and the continuous release of policy dividends, the vitality of the IVD industry has continued to burst .
In recent years, my country’s IVD market has become one of the most active areas in the medical device market
.
In August 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which kicked off the reform of the review and approval system for drugs and medical devices
.
In order to implement the reform spirit of the review, review and approval system, the national drug regulatory authority has launched a series of policy "combined punches": issuing and implementing "Special Review Procedures for Innovative Medical Devices" and "Priority Approval Procedures for Medical Devices", etc.
, to encourage industrial innovation and development; develop medical devices The registrant system is piloted to "untie" product registration and production licenses to stimulate R&D and innovation vitality
.
Encouraging innovation and development has achieved remarkable results
.
According to Zhao Yang, since 2014, as of July 14 this year, 113 innovative medical devices have been approved for marketing, including 17 IVD reagents and 4 IVD inspection equipment; the products that have passed the medical device priority approval process have been listed on the market.
38, including 21 IVD reagents and 2 IVD inspection equipment
.
As of the end of May this year, 1,377 products from 227 registrants in the pilot provinces (autonomous regions and municipalities) of the medical device registrant system have been approved for marketing under the registrant system; IVD reagents accounted for 65%
.
Product innovation is aimed at clinical needs.
The
national drug regulatory agency's exploration of reforming the medical device review and approval system began with the release of the "Special Approval Procedure for Innovative Medical Devices (Trial)" in February 2014
.
In 2018, the State Drug Administration revised and issued the "Special Review Procedures for Innovative Medical Devices", which opened a "green channel" for review and approval of innovative medical devices
.
Dong Jinchun, deputy director of the Evaluation Department of the Medical Device Technology Evaluation Center of the State Drug Administration, introduced that in the context of the implementation of the newly revised "Regulations", the IVD product evaluation work will further strengthen the support for innovative products; strengthen the guidance for the registration and application of innovative products ; Further enhance communication with the applicant enterprises
.
Dong Jinchun introduced that innovative medical devices mean that the main working principle/mechanism of the product is the first in China, and the performance or safety of the product is fundamentally improved compared with similar products.
The technology is at the international leading level and has significant clinical application value
.
IVD innovative products should focus on whether the new intended use has significant clinical application value, whether it can achieve its intended use, whether the use of the new test substance is clear, and whether the new methodology is reasonable, scientific, and effective
.
"The innovation of IVD products may be to find a brand-new marker, or it may be a new methodological improvement on the basis of the original marker, or it may have a new clinical significance
.
No matter from which point of view the innovation is made, companies should Oriented by clinical needs, only by solving clinical'pain points' can it have more application value
.
" said He Jingyun, Department of Clinical and Biostatistics, Medical Device Technology Review Center, National Food and Drug Administration
.
He Jingyun introduced that the goal of clinical trials of I VD products is to prove that the product can achieve the intended use; determine the applicable population and indications of the product; provide effective scientific evidence for the confirmation of product safety and effectiveness, and risk-benefit analysis
.
IVD the clinical trial design includes a key design element type, control systems, and statistical evaluation methods, subject choice, sample size estimation bias control
.
"For IVD innovative products, companies must understand where the innovations of the products are, and clarify the clinical positioning and clinical value of the products based on the innovations
.
Clinical value is the focus of the design of clinical trials for IVD innovative products, and it is also the consideration of product performance in the review and approval work.
Whether to enter the focus of the “ green channel ”.
” He Jingyun said that the clinical trial design of IVD innovative products should clarify the clinical positioning of the product on the basis of preliminary research, and determine the evaluation plan based on the product positioning; fully consider the clinical significance and innovation of the innovative product The impact of points on the key elements of clinical trial design; rational use of communication channels, communicate in advance, and solve problems before declaration
.
In addition, the rapid development of the industry cannot be guaranteed without a strong technical support system
.
In terms of improving the technical support system, the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" implemented in October 2014 clarified that the China Institute for Food and Drug Control (hereinafter referred to as the China Inspection Institute) is responsible for organizing the preparation and calibration of national standards and reference products.
.
"In order to comprehensively evaluate and control the quality of products , the China Inspection Institute has established a four-in-one quality evaluation system of national standard materials, industry standards, relevant standard operating specifications, and IVD reagent guidelines
.
" Deputy Director of the Institute of In Vitro Diagnostic Reagents, China Inspection Institute (Presiding work) Yang Zhen said that it was precisely based on the perfect quality evaluation system that the China Inspection Institute quickly developed the national standard material for new coronavirus detection reagents in the early stage of the prevention and control of the new crown pneumonia epidemic
.
Up to now, 9 national standard materials (including replacement batches) of new coronavirus detection reagents have been developed, laying a solid foundation for the emergency inspection and quality evaluation of related detection reagents
.
Exploring new paths still needs to focus on safety and effectiveness.
The
newly revised "Regulations" newly revised "Regulations" newly added medical institutions to develop reagent management system is a hot topic in the industry, and was mentioned many times during this meeting
.
Article 53 of the newly amended "Regulations" stipulates that for IVD reagents that do not have the same product on the market in China, qualified medical institutions can develop them on their own according to the clinical needs of their units, and use them in their units under the guidance of practicing physicians.
.
The specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council
.
This clause is a new clause based on the actual situation of medical institutions developing IVD reagents, drawing on the foreign laboratory development test (LDT) system, and combining China's national conditions
.
"LDT is defined in the United States as the testing methods and reagents developed in CLIA-accredited laboratories for the diagnosis and treatment of patient diseases, which are limited to the laboratory that developed the LDT
.
" National Health & HealthLi Jinming, deputy director of the Committee’s Clinical Laboratory Center, introduced that although IVD and LDT have the same clinical intended use, methodology, reagent composition, testing instruments, laboratory information systems, etc.
, there are very significant differences between the two
.
IVD is researched and developed by the manufacturer and approved by the National Drug Administration.
The analytical validity, clinical validity and clinical usefulness are known
.
The analytical validity, clinical validity, and clinical usefulness of LDT need to be researched and established by the laboratory; if the clinical expected use of one or a group of markers is confirmed, only research is needed to determine the analytical validity
.
In the process of clinical application of IVD, no reagent components and operating steps can be changed, while LDT can be updated at any time with the findings of research and clinical application.
It is suitable for polygenic detection of rare, rare and fast-developing diseases; IVD is suitable for common diseases And the detection of single or small number of markers
.
In addition, LDT is also suitable for continuously updated detection such as NGS, such as biological information analysis software, mutation filtering database, mutation interpretation database and standards, drug information database, phenotype database, and clinical effectiveness database
.
"LDT has completed the confirmation of clinical effectiveness, obtained clear clinical sensitivity, clinical specificity, detection rate, positive detection value, negative detection value, etc.
, and the number of patients is large enough, before it is possible to transform into IVD.
Products
.
” Li Jinming said that in order to ensure product quality and safety, clinical laboratories should conduct performance verification (IVDs) or performance verification (LDTs) for their testing reagent methods or systems, and ensure the quality of daily testing; companies can provide the raw materials required for LDT And the template for analyzing performance confirmation; industry associations should strengthen academic guidance and training in LDT standardization and standardization
.
During the salon discussion session, representatives from medical institutions and enterprises expressed that the IVD industry's innovation and development continues to be hot, and the newly revised "Regulations" encourage innovation policies will further promote the high-quality innovative development of the IVD industry
.
New policies such as the laboratory's self-developed reagents, emergency use, and the import of urgently needed clinical products will further promote the market and application of relevant clinically urgently needed IVD products as soon as possible
.
It is hoped that the relevant regulatory authorities will establish appropriate management practices or industry guidelines, and steadily advance the relevant policies as early as possible
.
The nearly four-hour conference was full of dry goods, and the guests at the conference expressed their feelings
.
Beijing Golden Key Gene Technology Co.
, Ltd.
CEO Jiang Zhi sighed: "Innovative companies in the IVD field need such a platform for cohesion and sharing.
The clinical trial design of IVD innovative products is a common problem faced by companies
.
The content shared by experts is deeply inspiring .
"
This conference is Tianjin’s 2021 “National Medical One of the theme activities of "Device Safety Promotion Week"
.
At the meeting, relevant persons, experts and scholars from regulatory agencies, medical institutions and enterprises conducted in-depth discussions and suggested high-quality development of the IVD (in vitro diagnostic) industry
.
The seminar attracted a large audience, and the meeting room was packed
.
Policies to stimulate the vitality of the IVD industry
On June 1, the newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the newly revised Regulations) were formally implemented
.
Article 8 of the newly revised "Regulations" clearly stipulates that the state formulates medical device industry plans and policies, incorporates medical device innovation into the development focus, prioritizes the review and approval of innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes medical devices High-quality development of the industry
.
"The newly revised "Regulations" newly added relevant content to encourage and support medical device innovation, which fully reflects the state's requirements for encouraging the innovative development of medical devices and promoting the high-quality development of medical devices
.
" Registration Division I, Medical Device Registration Management Department, State Drug Administration Zhao Yang, a Level 4 researcher, said at the meeting .
Zhao Yang introduced that in order to further encourage the innovation and development of the medical device industry, the "Regulations" were revised to establish a medical device registrant and recorder system; new regulations on medical device registration and filing can submit self-inspection reports; new medical device emergency use system ; new medical research reagent management systems .
It is worth mentioning that in recent years, with the continuous deepening of China's medical device review and approval system reform, the continuous innovation of the regulatory system, and the continuous release of policy dividends, the vitality of the IVD industry has continued to burst .
In recent years, my country’s IVD market has become one of the most active areas in the medical device market
.
In August 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which kicked off the reform of the review and approval system for drugs and medical devices
.
In order to implement the reform spirit of the review, review and approval system, the national drug regulatory authority has launched a series of policy "combined punches": issuing and implementing "Special Review Procedures for Innovative Medical Devices" and "Priority Approval Procedures for Medical Devices", etc.
, to encourage industrial innovation and development; develop medical devices The registrant system is piloted to "untie" product registration and production licenses to stimulate R&D and innovation vitality
.
Encouraging innovation and development has achieved remarkable results
.
According to Zhao Yang, since 2014, as of July 14 this year, 113 innovative medical devices have been approved for marketing, including 17 IVD reagents and 4 IVD inspection equipment; the products that have passed the medical device priority approval process have been listed on the market.
38, including 21 IVD reagents and 2 IVD inspection equipment
.
As of the end of May this year, 1,377 products from 227 registrants in the pilot provinces (autonomous regions and municipalities) of the medical device registrant system have been approved for marketing under the registrant system; IVD reagents accounted for 65%
.
Product innovation is aimed at clinical needs.
The
national drug regulatory agency's exploration of reforming the medical device review and approval system began with the release of the "Special Approval Procedure for Innovative Medical Devices (Trial)" in February 2014
.
In 2018, the State Drug Administration revised and issued the "Special Review Procedures for Innovative Medical Devices", which opened a "green channel" for review and approval of innovative medical devices
.
Dong Jinchun, deputy director of the Evaluation Department of the Medical Device Technology Evaluation Center of the State Drug Administration, introduced that in the context of the implementation of the newly revised "Regulations", the IVD product evaluation work will further strengthen the support for innovative products; strengthen the guidance for the registration and application of innovative products ; Further enhance communication with the applicant enterprises
.
Dong Jinchun introduced that innovative medical devices mean that the main working principle/mechanism of the product is the first in China, and the performance or safety of the product is fundamentally improved compared with similar products.
The technology is at the international leading level and has significant clinical application value
.
IVD innovative products should focus on whether the new intended use has significant clinical application value, whether it can achieve its intended use, whether the use of the new test substance is clear, and whether the new methodology is reasonable, scientific, and effective
.
"The innovation of IVD products may be to find a brand-new marker, or it may be a new methodological improvement on the basis of the original marker, or it may have a new clinical significance
.
No matter from which point of view the innovation is made, companies should Oriented by clinical needs, only by solving clinical'pain points' can it have more application value
.
" said He Jingyun, Department of Clinical and Biostatistics, Medical Device Technology Review Center, National Food and Drug Administration
.
He Jingyun introduced that the goal of clinical trials of I VD products is to prove that the product can achieve the intended use; determine the applicable population and indications of the product; provide effective scientific evidence for the confirmation of product safety and effectiveness, and risk-benefit analysis
.
IVD the clinical trial design includes a key design element type, control systems, and statistical evaluation methods, subject choice, sample size estimation bias control
.
"For IVD innovative products, companies must understand where the innovations of the products are, and clarify the clinical positioning and clinical value of the products based on the innovations
.
Clinical value is the focus of the design of clinical trials for IVD innovative products, and it is also the consideration of product performance in the review and approval work.
Whether to enter the focus of the “ green channel ”.
” He Jingyun said that the clinical trial design of IVD innovative products should clarify the clinical positioning of the product on the basis of preliminary research, and determine the evaluation plan based on the product positioning; fully consider the clinical significance and innovation of the innovative product The impact of points on the key elements of clinical trial design; rational use of communication channels, communicate in advance, and solve problems before declaration
.
In addition, the rapid development of the industry cannot be guaranteed without a strong technical support system
.
In terms of improving the technical support system, the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" implemented in October 2014 clarified that the China Institute for Food and Drug Control (hereinafter referred to as the China Inspection Institute) is responsible for organizing the preparation and calibration of national standards and reference products.
.
"In order to comprehensively evaluate and control the quality of products , the China Inspection Institute has established a four-in-one quality evaluation system of national standard materials, industry standards, relevant standard operating specifications, and IVD reagent guidelines
.
" Deputy Director of the Institute of In Vitro Diagnostic Reagents, China Inspection Institute (Presiding work) Yang Zhen said that it was precisely based on the perfect quality evaluation system that the China Inspection Institute quickly developed the national standard material for new coronavirus detection reagents in the early stage of the prevention and control of the new crown pneumonia epidemic
.
Up to now, 9 national standard materials (including replacement batches) of new coronavirus detection reagents have been developed, laying a solid foundation for the emergency inspection and quality evaluation of related detection reagents
.
Exploring new paths still needs to focus on safety and effectiveness.
The
newly revised "Regulations" newly revised "Regulations" newly added medical institutions to develop reagent management system is a hot topic in the industry, and was mentioned many times during this meeting
.
Article 53 of the newly amended "Regulations" stipulates that for IVD reagents that do not have the same product on the market in China, qualified medical institutions can develop them on their own according to the clinical needs of their units, and use them in their units under the guidance of practicing physicians.
.
The specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council
.
This clause is a new clause based on the actual situation of medical institutions developing IVD reagents, drawing on the foreign laboratory development test (LDT) system, and combining China's national conditions
.
"LDT is defined in the United States as the testing methods and reagents developed in CLIA-accredited laboratories for the diagnosis and treatment of patient diseases, which are limited to the laboratory that developed the LDT
.
" National Health & HealthLi Jinming, deputy director of the Committee’s Clinical Laboratory Center, introduced that although IVD and LDT have the same clinical intended use, methodology, reagent composition, testing instruments, laboratory information systems, etc.
, there are very significant differences between the two
.
IVD is researched and developed by the manufacturer and approved by the National Drug Administration.
The analytical validity, clinical validity and clinical usefulness are known
.
The analytical validity, clinical validity, and clinical usefulness of LDT need to be researched and established by the laboratory; if the clinical expected use of one or a group of markers is confirmed, only research is needed to determine the analytical validity
.
In the process of clinical application of IVD, no reagent components and operating steps can be changed, while LDT can be updated at any time with the findings of research and clinical application.
It is suitable for polygenic detection of rare, rare and fast-developing diseases; IVD is suitable for common diseases And the detection of single or small number of markers
.
In addition, LDT is also suitable for continuously updated detection such as NGS, such as biological information analysis software, mutation filtering database, mutation interpretation database and standards, drug information database, phenotype database, and clinical effectiveness database
.
"LDT has completed the confirmation of clinical effectiveness, obtained clear clinical sensitivity, clinical specificity, detection rate, positive detection value, negative detection value, etc.
, and the number of patients is large enough, before it is possible to transform into IVD.
Products
.
” Li Jinming said that in order to ensure product quality and safety, clinical laboratories should conduct performance verification (IVDs) or performance verification (LDTs) for their testing reagent methods or systems, and ensure the quality of daily testing; companies can provide the raw materials required for LDT And the template for analyzing performance confirmation; industry associations should strengthen academic guidance and training in LDT standardization and standardization
.
During the salon discussion session, representatives from medical institutions and enterprises expressed that the IVD industry's innovation and development continues to be hot, and the newly revised "Regulations" encourage innovation policies will further promote the high-quality innovative development of the IVD industry
.
New policies such as the laboratory's self-developed reagents, emergency use, and the import of urgently needed clinical products will further promote the market and application of relevant clinically urgently needed IVD products as soon as possible
.
It is hoped that the relevant regulatory authorities will establish appropriate management practices or industry guidelines, and steadily advance the relevant policies as early as possible
.
The nearly four-hour conference was full of dry goods, and the guests at the conference expressed their feelings
.
Beijing Golden Key Gene Technology Co.
, Ltd.
CEO Jiang Zhi sighed: "Innovative companies in the IVD field need such a platform for cohesion and sharing.
The clinical trial design of IVD innovative products is a common problem faced by companies
.
The content shared by experts is deeply inspiring .
"
