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Biomedical Human Clinical Trials Liability Insurance Policy
Biomedical Human Clinical Trials Liability Insurance Policya _ Compensation mechanism to implement premium subsidies for eligible drugs, medical devices and medical technology clinical trials
1
2 ► From 2017 to now, in order to promote the high-quality development of the biopharmaceutical industry and reduce the innovation risks of related enterprises and hospitals, the applicants for clinical trial premium subsidies have gradually expanded [1-3] .
2.
Policy text (excerpt)
The administrative departments of science and technology in all districts and all relevant units:
The administrative departments of science and technology in all districts and all relevant units:In order to implement the requirements of the "Several Opinions on Promoting the High-quality Development of the Biomedical Industry in this Municipality" (Hu Fu Ban Gui [2021] No.
In order to implement the requirements of the "Several Opinions on Promoting the High-quality Development of the Biomedical Industry in this Municipality" (Hu Fu Ban Gui [2021] No.
1.
Investigator-Initiated Clinical Studies
Investigator initiated trials (IITs) are not aimed at drug registration, but to expand and optimize existing therapies, and their research content is often closer to the needs of clinical patients , such as comparing the pros and cons of multiple clinical treatments and Rare disease treatment
Investigator initiated trials (IITs) are close to the needs of clinical patients, the pros and cons of multiple clinical treatments and the depth and breadth of rare disease treatment drug research
Clinical Trial Insurance
Clinical Trial InsuranceAccording to the latest version of GCP, sponsors should provide investigators and clinical trial institutions with legal and economic insurance or guarantees related to clinical trials, which should be commensurate with the nature and degree of risk of clinical trials
Prospective, interventional IIT studies have certain risks, and it is also necessary to purchase clinical trial insurance for the subjects
List of important points for premium application
At present, the IIT research carried out in Shanghai has shown a trend of rapid growth.
01.
01.
2 Medical and health institutions in this city ;
2 The city's medical and health institutions3 Institutions and enterprises engaged in the research and development and production of drugs and medical devices;
4 Businesses that provide contract R&D and production services
02.
02.
Types of clinical trials:
Clinical research on drugs, medical devices, medical technology
Clinical research on drugs, medical devices, medical technology1 Drugs: Class 1-3 of chemical drugs registered and classified according to the current "Measures for the Administration of Drug Registration"; Classes 1-4 of the registration classification of traditional Chinese medicines; In vitro diagnostic reagents
1 medicine:
2 Medical devices: Class II and Class III according to the current "Medical Device Classification Rules"
.
3 Medical technology: the medical professional means and measures specified in the current "Administrative Measures for Clinical Application of Medical Technology"
.
03.
Points to note about applying for subsidies for IIT clinical trials
Points to note about applying for subsidies for IIT clinical trials
1 Can all drug, medical device or medical technology clinical research initiated by researchers in Shanghai medical and health institutions apply for this subsidy?
All clinical research on drugs, medical devices or medical technologies initiated by researchers in Shanghai medical and health institutions, as long as the clinical research has obtained ethics approval and is registered in a trial that meets the World Health Organization registration standards and is approved by the International Committee of Medical Journal Editors (ICMJE).
Institutions and platform registrations can apply for subsidies
.
2 Can a clinical research initiated by a researcher in a medical and health institution funded by an enterprise apply for a subsidy?
Shanghai enterprises sponsor clinical trials carried out by medical and health institutions in Shanghai .
Shanghai enterprises purchase insurance policies and provide funding agreements.
Shanghai enterprises can apply for subsidies ; Medical and health institutions can apply for subsidies
.
.
04.
About policy fees and application process
About policy fees and application process
1 How much is the premium subsidy? Is there a cap per business/institution?
A special financial subsidy of 50% of the premium for policies that meet the notification conditions, and the subsidy for a single policy does not exceed 500,000 yuan ; only the subsidy ratio and subsidy upper limit are set for each policy, and each enterprise/institution does not limit the number of subsidy policy
.
2 The following figure shows the application process and application materials.
After purchasing an insurance policy and obtaining the corresponding application materials, you can apply for subsidies to the Shanghai Science and Technology Entrepreneurship Center within 6 months
.
After passing the expert review meeting, the account will be credited within 6 months
.
Acceptance dates from July 1, 2022 to July 31, 2022 :
application process
application process
Application materials
Application materials
summary
summary The introduction of the favorable policy that IIT research can apply for premium subsidies will prompt more attention to focus on this, escort the smooth development of IIT in medical structures at all levels, and once again highlight the importance of clinical trials initiated by researchers.
It demonstrates the R&D spirit oriented by clinical value
.
It is believed that more and better policies will benefit a wider area in the future and increase the enthusiasm of researchers to participate
.
.
references
References References 1 "Notice on Carrying out the Pilot Work of Liability Insurance for Biomedical Human Clinical Trials and Liability Insurance for Biomedical Products" (Hu Ke [2017] No.
438)
438)
2 "Notice on Carrying out Liability Insurance for Biomedical Human Clinical Trials and Liability Insurance for Biomedical Products" (Hu Ke He [2020] No.
4)
4)
3 "Notice on Carrying out Liability Insurance for Biomedical Human Clinical Trials" (Hu Ke He [2022] No.
1)
1)
4 Shanghai Clinical Trial Insurance Premium Subsidy Policy Helps Life Blue Bay Enterprises Innovate - "Lingang Blue Bay" Public Account (2022.
3.
24)
3.
24)
