Beijing invested to support the be test of conformity assessment, with a maximum of 3 million yuan

Source: E-face on September 12, 2016, the biomedical Department of Beijing Municipal Commission of science and Technology issued the notice on the collection of scientific research projects for conformity assessment of generic drugs (hereinafter referred to as the "notice"), which will collect mature varieties of advantages for Beijing generic drug manufacturers and support the acceleration of the research and development of conformity assessment Which varieties can be supported? The requirements of the notice for the varieties to be supported are as follows: first, they belong to the varieties in the catalogue of generic drug conformity evaluation varieties to be completed by the end of 2018 (Announcement No 106 of the State Food and Drug Administration in 2016) Second, the declared varieties shall have clearly selected the reference preparation, which shall be consistent with the selected reference preparation in terms of dosage form, base, specification, etc Third, refer to 2018 issued by the State Food and Drug Administration on August 17 By the end of the year, the number of approval numbers of generic drug quality and efficacy consistency evaluation varieties shall be completed The varieties with exclusive approval or exclusive production shall be declared and supported preferentially For the varieties with more approval numbers and more manufacturers, the clinical significance, market competitiveness, pharmaceutical technology foundation, feasibility of consistency evaluation scheme and other factors of the varieties shall be comprehensively investigated and the best support shall be selected In addition, each enterprise is required to declare no more than three varieties, with a single variety as the unit, and different specifications are regarded as the same variety What is the evaluation content of support? According to the notice, the key content supported by Beijing Municipal Science and Technology Commission is in vitro consistency evaluation research, with the implementation cycle from October 2016 to December 2017 The assessment requirements are to obtain the dissolution curve results with differentiated force by the end of 2017, to form the in vitro consistency evaluation report, to pass the approval of the ethics committee of in vivo bioequivalence test (be test) or to reach the mature conditions for conducting be test At the same time, the varieties applying for be test shall be approved by the ethics committee before the deadline of application The implementation cycle is from October 2016 to October 2018 The assessment requirements are to complete the be test and form a summary report The point is how much is the support? According to the notice, it is proposed to support 1-2 million yuan of science and technology funds for varieties carrying out in vitro consistency evaluation research and 2-3 million yuan of science and technology funds for varieties carrying out be test At the same time, for the varieties that complete the in vitro consistency evaluation research on schedule, it can also assist in docking the clinical pharmacology base, speed up the be test, and give priority to rolling support to the be test In fact, Beijing is not the only place where local governments support the consistency evaluation of generic drugs Earlier, according to a CFDA official, local governments including Heilongjiang and Sichuan are also supporting pharmaceutical companies in funding to speed up the pace of consistency evaluation.