Shanghai tries to evaluate the consistency of generic drugs through multi cooperation!

Source: in the "13th five year plan guide for pharmaceutical industry" issued by six ministries and commissions including the Ministry of industry and information technology of the people's Republic of China on December 9, 2016, xinhuanet.com listed the conformity evaluation of generic drugs in the product quality upgrading project, which will bring a great reshuffle of supply side reform in the biomedical industry The relevant policies are basically complete, the regulatory attitude is very clear, and the pharmaceutical enterprises enter the countdown "life and death arena" However, in addition to the pressure of capital investment, tight time and heavy task, there are many difficulties in consistency evaluation, such as the approval and compliance procurement of reference preparations, and the scarcity of human bioequivalence test medical institutions, which are difficult to be completed by a pharmaceutical company alone The reporter learned from Shanghai Pharmaceutical Group Co., Ltd that Shanghai Pharmaceutical Group Co., Ltd signed strategic cooperation framework agreement on drug clinical trial research with Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College, Huashan Hospital Affiliated to Fudan University and other famous top three hospitals in Shanghai In the future, they will cooperate in many aspects At present, 32 varieties of be (bioequivalence) cooperation intentions have been determined Chen Yaoshui, deputy director of Shanghai food and drug administration, said that Shanghai is the cradle of generic drugs and one of the regions with more one-time evaluation documents But there are only 44 Medical Institutions with clinical experiment qualification in Shanghai, and only half of them have the ability to do bioequivalence human trials At present, the consistency evaluation time is tight and the task is heavy The price of a project is also rising and the supply is in short supply This strategic cooperation is to help people choose the best medicine through the complementary resources of hospitals and enterprises Shouziqi, director of Shanghai Science and Technology Commission, said that Shanghai is building a large life science center, which is to give full play to its resources and advantages and strive to build a standardized, quality, influential and truly functional clinical center "Next, cooperation will be solidly promoted to promote the level of pharmaceutical industry."