Release of 2015 Guangdong Drug Registration Annual Report

Lu Xianping checks the data in the laboratory at the R & D center of the headquarters of Shenzhen micro core Biotechnology Co., Ltd on June 30, Guangdong food and Drug Administration held a regular news conference in June I learned from the meeting that our province has taken many measures to encourage biomedical innovation and accelerate the acceptance and verification of innovative drugs In recent two years, the number of class 1 new drug applications has reached a historical high At the same time, Guangdong Province innovated the working procedures and management mechanism, opened the "fast lane" for the review and approval of drug technology transfer, accelerated the efficiency increase, effectively promoted the merger and reorganization of pharmaceutical enterprises and accelerated the settlement of advantageous industrial projects in Guangdong The 2015 annual report on drug registration of Guangdong Province released at the meeting showed that the drug R & D and application work of Guangdong Province showed a promising trend of "combination of innovation and imitation, focusing on innovation", the strength of drug R & D was further enhanced, and the structure proportion of new drugs and generic drugs was more reasonable In recent two years, the application volume of new class 1 drugs in Guangdong has reached a historical high It is reported that in recent years, many measures have been taken to encourage the innovation of biomedicine in Guangdong Province and remarkable results have been achieved For example, we should adhere to the implementation of "green channel" for the registration of innovative drugs and drugs for the treatment of major and difficult diseases, and speed up the acceptance and verification of innovative drugs The average time limit for reporting is 20 days, 40% - 50% faster than the legal time limit The number of innovative drug applications in Guangdong Province has increased significantly due to the policy of encouragement In 2014 and 2015, the number of class 1 new drugs declared reached 22 and 20 respectively, reaching a historical high At the same time, since the provincial food and drug administration was authorized to carry out technical review and administrative approval on the technology transfer application put forward by the drug manufacturing enterprises in the province, our province has innovated the working procedures and management mechanism, opening up the "fast lane" for the review and approval of drug technology transfer to speed up the efficiency Compared with the original approval process, the average time limit is shortened by 15-20 working days, and the total time limit from acceptance to approval is shortened by 30-40 working days Over the past two years since the implementation of the first trial policy, the provincial food and drug administration has completed the review and approval of technology transfer of 31 varieties, including 25 drug approval numbers approved and issued by the State Food and drug administration Among the approved drugs, 17 have higher "gold content" with "new drug certificate", including 2 class I new drugs and 3 class II new drugs It has created a favorable policy environment for the development of the pharmaceutical industry, formed a "policy depression" effect, and effectively promoted the merger and reorganization of pharmaceutical enterprises and accelerated the settlement of advantageous industrial projects in Guangdong Guangdong's research strength in traditional Chinese medicine and biological products has been enhanced year by year The annual report on drug registration in Guangdong Province in 2015 has also been released The report shows that the total amount of new drug registrations in Guangdong Province is increasing year by year, consistent with the national trend In 2015, the number of new drug registration applications in our province was 266, which was basically the same as 270 in 2014 The number of new drug applications is still higher than that of generic drugs, and the number of new drug registration applications is still high in the past five years The report shows that in recent years, from the perspective of the number and structural proportion of new drug and generic drug registration applications in Guangdong Province, under the comprehensive effect of persistent macro policy guidance and continuously strengthened registration and supervision means in recent years, the drug R & D and application work in Guangdong Province presents a promising trend of "combination of creation and imitation, focusing on creation", and the strength of drug R & D is further enhanced New drugs and generic drugs The proportion of structure is more reasonable "New drugs with significant clinical efficacy and less toxic and side effects have been declared and approved for marketing in succession, which not only brings well-being to the public, but also further improves the input source power for the sustainable development and potential market competitiveness of the pharmaceutical industry in Guangdong Province." Liu Zhen, the Registrar of the provincial food and drug administration, said According to Liu Zhen, the number of newly registered and approved drugs in Guangdong Province is similar to the number of approved drugs in China However, according to the classification of drug registration, the proportion of the accepted amount of traditional Chinese medicine and biological products in Guangdong Province in 2014 and 2015 is higher than the national average level, which indicates that the research strength of traditional Chinese medicine and biological products in Guangdong Province is increasing year by year "This is related to our many initiatives in recent years to encourage biomedical innovation and accelerate the acceptance and verification of innovative drugs It also provides a solid foundation for the restructuring of the biomedical industry and the promotion of transformation and development." 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 A series of investigation found that there are 173 drug varieties, 1391 approval numbers and 102 enterprises involved in the first batch of drug products requiring consistency evaluation in Guangdong 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 Guangdong food and drug administration also implements the "one window acceptance" system, optimizes the administrative licensing and drug registration process, and promotes centralized approval; and promotes the "integration of multiple licenses" of food and drugs, so as to realize the synchronous acceptance, examination and synchronization of drug production license and GMP certification, drug marketing license and GSP certification Approval.