Carry out biomedical human clinical trial liability insurance work

About the development of biomedical human clinical trials

Notice of liability insurance work

Hukehe [2022] No. 1

The competent administrative departments for science and technology in each district and all relevant units:

In order to implement the requirements of the General Office of the Shanghai Municipal People's Government "Several Opinions on Promoting the High-quality Development of the Biomedical Industry in Shanghai" (Shanghai Government Office Regulation [2021] No. 5), accelerate the construction of a biomedical industry innovation highland with international influence, promote the high-quality development of the biomedical industry, reduce the innovation risks of relevant enterprises, hospitals and other units, it is proposed to establish a compensation mechanism for the liability insurance of biomedical human clinical trials in the city, and implement premium subsidies for qualified drugs, medical devices and medical technology clinical trials. The relevant work is hereby notified as follows:

One

The applicants are the applicants for biomedical human clinical trials registered in this city (except individuals), the medical and health institutions in this city, institutions and enterprises engaged in the research and development and production of drugs and medical devices, and enterprises that provide contract research and development and production services.

Two

Municipal financial capital arrangements will give 50% of the financial subsidies to eligible entities' premiums, and the subsidies for a single insurance policy shall not exceed 500,000 yuan.

Three

The conditions for applying for the biomedical human clinical trial liability insurance subsidy are as follows:

1. Scope of subsidies:

Drugs are chemical drugs classified according to the current Measures for the Administration of Drug Registration No. 1-3, Chinese medicine registration classification classes 1-4, biological products registration classification therapeutic biological products, preventive biological products, and in vitro diagnostic reagents managed according to biological products. Medical devices are class II and class III classified according to the current Rules for the Classification of Medical Devices. Medical technology is a medical professional means and measures specified in the current Measures for the Administration of Clinical Application of Medical Technology.

2. Application requirements:

Drug clinical trials must obtain the drug clinical trial approval or clinical trial notice from the State Drug Administration; the bioequivalence test of generic drugs must be filed with the State Drug Administration. Human clinical trials of medical devices must be filed with the National or Municipal Drug Administration. Clinical studies initiated by healthcare institutions are subject to ethical approval and registered with trial registries and platforms that meet WHO registration standards and are approved by the International Board of Medical Journals Editorial Board (ICMJE).

Four

Institutions and enterprises that meet the above conditions can apply for premium subsidies to the Shanghai Science and Technology Entrepreneurship Center after insurance application, and the Municipal Science and Technology Commission will review and publicize them.

Five

The Notice shall be effective from the date of publication and shall be effective until 31 December 2023.

Notice is hereby given.

Shanghai Municipal Science and Technology Commission

Shanghai Municipal Financial Supervision and Administration Bureau

Shanghai Supervision Bureau of China Banking and Insurance Regulatory Commission

January 11, 2022