Guangzhou Biomedical industry innovation subsidy application, the highest award of 5 million

2022-06-30 0 By

For content guangzhou biological medicine industry innovation grant (2021) reporting guidelines for as of February 18, 2022 new drug clinical research scope of subsidies subsidies on January 1, 2021 to December 2021, 31 days new starting project of clinical research of new drugs and promised to get benefits of new drug products in the unit can be applied for the guangzhou city to realize industrializationThe time of enrollment of the first subject is taken as the start time of the trial, and the clinical trial must be carried out in China.If the application for clinical trial to the National Medical Products Administration involves a joint applicant, the first approval unit shall submit an application for subsidy. If it is not the first approval unit, relevant approval transfer materials shall be provided, and the consent of other co-owners shall be obtained.(1) For class 1 biological products, class 1 chemical drugs and Class 1 Traditional Chinese medicine, according to clinical phase I, II and III, the subsidy will be 2 million yuan, 3 million yuan and 5 million yuan, respectively;(2) According to clinical phase I, II and III, subsidies of 1 million yuan, 1.5 million yuan and 2.5 million yuan will be given to class 2-3 biological products, class 2 chemical drugs and class 2-4 Traditional Chinese medicine, respectively.New drug projects that have not started clinical trials according to the sequence of clinical phase I, II and III can be subsidized according to the high principle, and the same new drug project will not be supported repeatedly.On the basis of the above two levels of subsidies, the amount of subsidy will be increased by 50% for those who entrust drug clinical trial institutions in Guangzhou to carry out clinical trials.Medical equipment product registration assistance coverage on January 1, 2021 to December 2021, 31 days of the second and third class medical equipment product registration certificate for the first time the enterprises can apply for the subsidies, will be subject to registration number recorded in the year that require registration certificate before the subsidy application online submission deadline is still in the period of validity.If the medical device product registration involves a joint registered unit, the first unit shall apply for subsidies and obtain the consent of other co-owners.(1) For those who enter the special approval procedure for innovative medical devices of Guangdong Provincial Medical Products Administration and obtain the first registration certificate of Category II medical devices, a subsidy of RMB 3 million will be given;Those who enter the NMPA special examination procedure for innovative medical devices and obtain the first registration certificate of category III medical devices will be given a subsidy of RMB 5 million;(2) For those who complete the clinical trial as required and obtain the first registration certificate of Category II and Category III medical devices in the key support field, they will be given a subsidy of 500,000 yuan and 1 million yuan respectively;(3) For those who obtain the first registration certificate of Category II and Category III medical devices in key supported fields without conducting clinical trials, a subsidy of RMB 250,000 yuan and RMB 500,000 yuan will be given respectively;(4) For those who obtain the first registration certificate of category II and Category III medical devices in non-key support areas, they will be subsidized 50,000 yuan and 100,000 Yuan respectively.The same registration certificate is not supported repeatedly.Institutions that have obtained the approval of drug non-clinical safety evaluation institutions, international Laboratory Animal Assessment and Accreditation Committee certification, and drug/medical device clinical trial institutions to build research wards and put into use within January 1, 2021 to December 31, 2021 can apply for this kind of subsidy.Based on the date of the accreditation certificate or the completion and use of the ward, only professional records are not a phase I clinical research ward.Subsidy standard (1) Those who obtain the GLP certification approval for the first time, and whose certification items reach more than 3 items (inclusive), 6 items (inclusive) and 9 items (inclusive), will be given a subsidy of 1 million yuan, 2 million yuan and 4 million yuan respectively;(2) Those who obtain AAALAC certification for the first time will be given a one-time subsidy of RMB 2 million;(3) If a GCP institution builds a phase I clinical research ward and puts it into use, it will give a one-time subsidy of RMB 2 million to its supporting units.Scope of research and clinical trials subsidies subsidies on January 1, 2021 to December 2021, 31 days drug non-clinical safety evaluation agency qualification certificate, the international assessment of experimental animals and approval commission certification, drug/medical instrument clinical trial institution built research ward and in use of institutions in the city, you may apply for the subsidies,Based on the date of the accreditation certificate or the completion and use of the ward, only professional records are not a phase I clinical research ward.(1) If the institution provides biomedical R&D services for the enterprise, the subsidy shall be 5% of the invoice amount of service activities issued by the applicant institution, and the accumulative subsidy for the same applicant in the same year shall not exceed 30 million yuan;(2) Institutions providing clinical trial services for new drugs will be subsidized 1 million yuan, 2 million yuan and 3 million yuan respectively according to the completion of more than 10, 20 or 30 clinical trial projects as the lead or as the lead. The clinical trial stages of new drugs are generally divided into phase I, II and III.Does not include bioequivalence test, generic drug clinical trial, etc.Key words: Guangzhou policy, Guangzhou project, Guangzhou biomedical industry innovation subsidy