notice on soliciting the research and development projects of shanghai biomedical innovation products in 2023

completed from 1 june 2021 to 30 june 2023 I period or II phase clinical trials and obtained I period or II class 1 chemical drugs, class 1 biological products and class 1 chinese medicine reported in phase clinical trials.

completed from 1 june 2021 to 30 june 2023 II phase clinical trials and obtained II a new improved drug reported in phase clinical trials.

medical device products that enter the national and city’s special approval procedures for innovative medical devices from june 1, 2021 to june 30, 2023.

in addition to meeting the above-mentioned corresponding conditions, the following requirements must also be followed:

1.the project application unit shall be the applicant for registration of biomedical innovative products in this city and promise to produce it in this city.

2.all applicants and project participants should abide by scientific research ethics standards, comply with relevant regulations on human genetic resources management and relevant regulations on biosafety management of pathogenic microbial laboratories, and comply with the requirements of scientific research integrity management. the project manager shall promise the authenticity of the submitted materials. the application unit shall be responsible for the applicant's application qualifications and review the authenticity and completeness of the application materials. it shall not submit project applications with confidential content.

3.the project application unit shall truthfully and reasonably report the investment in r&d of innovative products.

4.if an application for abstention expert is submitted for the application project, the official letter issued by the application unit must be submitted in writing to submit a list of experts and reasons for abstention expert.

5.clinical trial approval notice and ethical review opinions must be provided when applying. /approval documents, clinical trial reports, certificates for special approval procedures for entering innovative medical devices, etc.

please send written materials to shanghai science and technology government service center (1st floor, technical and trade building, no. 1525 zhongshan west road, xuhui district). the government service center does not accept written materials delivered by mail or express delivery. the centralized receipt of written materials is from july 24 to august 18, 2023, and is from 9:30 to 16:30 every working day. if the delivery is overdue, the acceptance will not be accepted.

service hotline:

021-12345

8008205114（landline)

4008205114（cell phone)

download the original text of the notice and attachments:https://stcsm.sh.gov.cn/zwgk/kyjhxm/xmsb/20230724/cab15624c90644c88668e2120cf9a892.html