Guangdong: consistency evaluation of thousands of drugs completed in three years

Source: Yangcheng Evening News 2016-07-01 2015 is a year when the state intensively introduced the new drug registration policy Among them, the evaluation of drug quality consistency has become the most concerned topic On June 30, 2016, Guangdong food and Drug Administration announced the 2015 annual report on drug registration in Guangdong Province (hereinafter referred to as the "report"), Liu Zhen, director of the registration office of Guangdong food and drug administration, disclosed that thousands of drugs in Guangdong will complete the consistency evaluation by the end of 2018 Since July 2015, the total amount of drug registration has been increasing year by year The State Food and drug administration has successively issued a number of new policies on drug registration, which have put forward new norms and requirements for the reform of drug review and approval, drug registration application fees, registration classification, priority review, etc., and become a hot spot in the industry The implementation of the new policy makes the drug declaration structure in Guangdong more reasonable The report shows that the total amount of new drug registrations in Guangdong Province is increasing year by year The number of applications in 2015 was 266, which was basically the same as 270 in 2014 Application for new drugs is still higher than that for generic drugs, and application for new drug registration is still at a high level in the past five years The number of applications for innovative drugs in Guangdong Province increased significantly due to various incentive policies In 2014 and 2015, the number of applications for class 1 new drugs reached 22 and 20 respectively, which was also a historical high The consistency evaluation plan will be released in 2015, which is a year for the state to intensively introduce the new policy of drug registration, and at the same time, it will open the curtain of drug registration and approval reform Among them, the opinion of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs is the most influential According to the quantitative indicators to be given by the State Food and Drug Administration for consistency evaluation, the chemical generic oral solid preparations listed in the national essential drug catalog (2012 version) approved for marketing before October 1, 2007 shall, in principle, complete the consistency evaluation before the end of 2018 Liu Zhen told reporters that a series of investigation found that there were 173 drug varieties, 1391 approval numbers and 102 enterprises involved in the first batch of drugs in Guangdong that needed consistency evaluation Considering that some of the thousands of approvals have not been produced for a long time, some of them may give up the consistency evaluation due to market problems Finally, it is clear that less than one thousand drugs need to be evaluated for consistency "In the next step, we will ask the enterprise to tell the provincial bureau what is clear about consistency evaluation and what is clear about giving up, and the Provincial Bureau will also issue the implementation plan for consistency evaluation of quality and efficacy of generic drugs of Guangdong food and drug administration as soon as possible." Liu Zhen said.