The Development and Reform Commission of Shenzhen Municipality issued the Notice on Organizing Applications for the Special Support Program for Market Access of Drugs and Medical Devices (“Notice”) on January 4. According to the Notice, Shenzhen, to accelerate the development of its biomedical industry, will launch applications for the Special Support Program for Market Access of Drugs and Medical Devices to fund innovative drugs and medical device products that are undergoing clinical trials at home and abroad or are eligible for registration and marketing.
The special support program is divided into the drug clinical trial and approval support program and the medical device registration and certification support program. The program applicants must be enterprises registered in Shenzhen (including in the Shenshan Special Cooperation Zone), with independent legal personality, and engaging in drug and medical device R&D or production.
According to the Notice, in terms of the drug clinical trial and approval support program, Shenzhen plans to fund Class 1/2 chemical drugs, Class 1/2 biological products and Class 1/2 traditional Chinese medicines and natural drugs that have received drug clinical trial approvals or have been completed Phase I/II/III clinical trials in China according to the NMPA’s Provisions for Drug Registration (Order No. 27 of the State Administration for Market Regulation) and related registration classification rules.
In terms of the specific funds, Shenzhen plans to fund Class 1 chemical drugs, Class 1 biological products, and Class 1 traditional Chinese medicines and natural drugs at 40% of the expenses approved in the project review reports, with a maximum of RMB 8 million for those having received clinical approvals and a maximum of RMB 10 million, RMB 20 million, and RMB 30 million for those having been completed Phase I, Phase II, and Phase III clinical trials, respectively, and the maximum funding will be further increased by RMB 2 million separately for those whose clinical trials are entrusted to recognized clinical trial contract research organizations (CROs) in Shenzhen or hospital institutions in Shenzhen. Furthermore, if an enterprise has multiple drug varieties that meet application requirements, the enterprise shall apply for the program with each variety as an independent project. The maximum funding an enterprise can receive every year is RMB 100 million.
According to the Notice, in terms of the medical device registration and certification support program, Shenzhen plans to fund, ex-post, Class II/III medical device products applied for and approved through conventional channels at 40% of the expenses approved in the project review reports, with a maximum of RMB 2 million and RMB 3 million, respectively, and fund, ex-post, Class II/IIII innovative medical device products applied for and approved through the special approval channel at 40% of the expenses approved in the project review reports, with a maximum of RMB 3 million and RMB 5 million, respectively.
Program applicants can apply to the Development and Reform Commission of Shenzhen Municipality from the date of the Notice. It’s worth noting that applicants must meet the application conditions stipulated in the application guide and organize the preparation of project fund application reports as required in the application guide.
For the original Notice, please click the link: http://www.camdi.org/news/10580.
The special support program is divided into the drug clinical trial and approval support program and the medical device registration and certification support program. The program applicants must be enterprises registered in Shenzhen (including in the Shenshan Special Cooperation Zone), with independent legal personality, and engaging in drug and medical device R&D or production.
According to the Notice, in terms of the drug clinical trial and approval support program, Shenzhen plans to fund Class 1/2 chemical drugs, Class 1/2 biological products and Class 1/2 traditional Chinese medicines and natural drugs that have received drug clinical trial approvals or have been completed Phase I/II/III clinical trials in China according to the NMPA’s Provisions for Drug Registration (Order No. 27 of the State Administration for Market Regulation) and related registration classification rules.
In terms of the specific funds, Shenzhen plans to fund Class 1 chemical drugs, Class 1 biological products, and Class 1 traditional Chinese medicines and natural drugs at 40% of the expenses approved in the project review reports, with a maximum of RMB 8 million for those having received clinical approvals and a maximum of RMB 10 million, RMB 20 million, and RMB 30 million for those having been completed Phase I, Phase II, and Phase III clinical trials, respectively, and the maximum funding will be further increased by RMB 2 million separately for those whose clinical trials are entrusted to recognized clinical trial contract research organizations (CROs) in Shenzhen or hospital institutions in Shenzhen. Furthermore, if an enterprise has multiple drug varieties that meet application requirements, the enterprise shall apply for the program with each variety as an independent project. The maximum funding an enterprise can receive every year is RMB 100 million.
According to the Notice, in terms of the medical device registration and certification support program, Shenzhen plans to fund, ex-post, Class II/III medical device products applied for and approved through conventional channels at 40% of the expenses approved in the project review reports, with a maximum of RMB 2 million and RMB 3 million, respectively, and fund, ex-post, Class II/IIII innovative medical device products applied for and approved through the special approval channel at 40% of the expenses approved in the project review reports, with a maximum of RMB 3 million and RMB 5 million, respectively.
Program applicants can apply to the Development and Reform Commission of Shenzhen Municipality from the date of the Notice. It’s worth noting that applicants must meet the application conditions stipulated in the application guide and organize the preparation of project fund application reports as required in the application guide.
For the original Notice, please click the link: http://www.camdi.org/news/10580.