State Food and drug administration issues 2010 annual report on drug registration and approval

Source: SFDA 2011-10-09 drug registration is the approval process for the State Food and drug administration to review the safety, effectiveness and quality controllability of the drugs to be marketed according to the drug administration law and the application of the drug registration applicant, and decide whether to approve the application In the supervision of the whole process of drug development, production, circulation and use, drug registration management is an important means to supervise the safety and effectiveness of drugs from the source Its fundamental purpose is to ensure the safety and effectiveness of listed drugs and to ensure and promote public health through scientific evaluation 1 Important measures for drug registration management in 2010 In 2010, drug registration management continued to practice the concept of scientific supervision, closely around the center of "quality and efficiency", with risk benefit assessment and risk management as the core, and adhere to the principle of "standardized approval, openness and transparency, and innovation encouragement" We have comprehensively promoted the reform of the system and mechanism and the construction of the legal system, strengthened the supervision of the whole process of the research of pharmaceuticals, further promoted the openness and fairness of the review and approval, improved the efficiency of the review and approval, and better fulfilled the responsibilities assigned by the drug administration law 1.1 to improve the regulatory system of drug registration, the first is to issue the guiding principles for ethical review of drug clinical trials, standardize and guide the ethical review of drug clinical trials of the ethics committee, strengthen the quality management of drug clinical trials and the protection of subjects, and improve the quality of ethical review of drug clinical trials We will continue to carry out the provisions on the administration of registration and filing of raw and auxiliary medical materials, the measures for the administration of pharmaceutical standards, the provisions on the administration of biological sample analysis laboratories in clinical trials, and the provisions on the administration of pharmaceutical I The research and drafting of the regulatory and normative documents, such as the guiding principles of clinical trial management, the provisions on the management of serious adverse event reporting and monitoring in clinical trials of drugs, and the technical requirements for registration of natural drugs Second, accelerate the construction of guiding principle system of drug research technology China research group of the international coordination meeting on technical requirements for registration of human drugs (ICH) was established to conduct in-depth study on international standards and technical specifications The translation of 216 guiding principles for drug research abroad has been completed, among which 150 guiding principles for the implementation of the proposed transformation have been solicited for comments, 31 guiding principles have been further revised according to the solicited comments, and the technical guiding principles for the necessity of drug carcinogenic test has been officially released and implemented The establishment of these guidelines will make the drug registration and evaluation more scientific and standardized, and will also guide and promote the development of new drugs in China to the international level 1.2 to ensure the scientific, fair and open review of drug registration, the first is to build a database of listed drugs, pharmaceutical excipients, dissolution determination methods, etc., so that the technical review of drugs is based on science and quantification Second, taking generic drugs as the starting point, the electronic declaration data format of chemical generic drugs was formulated, the electronic declaration was launched, and the efficiency of review and approval was improved The third is to ensure the scientificity and impartiality of the technical review work through major special conferences, innovative varieties communication and exchange meetings, expert consultation meetings, third-party verification, expert vote and other means Fourth, we will further tighten the standards for technical evaluation For high-risk vaccines and blood products, adhere to the review principles in line with international standards, and strictly carry out technical review to ensure the quality of such varieties; for new drugs that need to be used for a long time, increase the requirements of carcinogenicity test to ensure the safety of drug use; strictly carry out the subject review and technical requirements of antibiotic varieties Fifth, we will continue to increase information disclosure Open the review report, so that the applicant can fully understand the review process and the basis for review decision-making; through consultation day, open day, director's mailbox, online information feedback and other forms, constantly strengthen communication and exchange with all sectors of society, promote the open and transparent review work, and gradually achieve "sunshine review" 1.3 strengthen the supervision of traditional Chinese medicine and ethnic medicine First, jointly with the Ministry of health, the state people's Committee and the State Administration of traditional Chinese medicine, the implementation plan of recent key work of national ethnic medicine (2010-2012) was issued It is emphasized that we should give full play to the positive role of ethnic medicine in the prevention and treatment of diseases in ethnic minority areas, strengthen the supervision and management of ethnic medicine, and ensure the safety of drug use for the masses in ethnic minority areas Second, the Ministry of health and the State Administration of traditional Chinese medicine jointly issued the opinions on strengthening the management of traditional Chinese medicine preparations in medical institutions, which requires that the active role of traditional Chinese medicine preparations in the clinical diagnosis and treatment of traditional Chinese medicine in medical institutions be given full play to further promote the scientific and healthy development of traditional Chinese medicine preparations in medical institutions Third, we implemented the requirements of the State Council's opinions on supporting and promoting the development of traditional Chinese medicine, carried out a survey on the current situation of the supervision of traditional Chinese medicine and ethnic medicine, and further clarified the ideas, steps and measures to promote the healthy development of traditional Chinese medicine 1.4 strengthen the supervision and management of drug research process First, strengthen and improve the on-site verification of drug registration Each province (District, city) has sent hundreds of working groups and nearly 3000 people to carry out on-site inspection of drug registration throughout the year, which provides a strong guarantee for drug technical evaluation Through questionnaire survey and field investigation, this paper summarizes and analyzes the on-site inspection of drug registration in recent years, and details the key points of on-site inspection and related format requirements Second, carry out GLP / GCP certification In 2010, we received GLP certification applications from 15 drug R & D institutions and GCP certification applications from 48 medical institutions, sent 80 inspection teams and 354 people to 129 institutions to carry out GLP or GCP certification tests, 10 and 38 institutions passed GLP and GCP respectively Authentication Third, carry out the pilot of electronic supervision of drug clinical trials The information management system of drug clinical trials was established, and the pilot of electronic supervision of drug clinical trials was carried out in 6 hospitals in Tianjin Through the development of electronic supervision of clinical trials, the behavior of drug clinical research was standardized, the supervision efficiency of clinical trials was improved, and the lack of supervision in the process of clinical trials was effectively solved Fourth, we have carried out special research work on the management system of drug registration applicants, the hierarchical and classified management mode of drug research institutions and the construction of drug research and supervision information system, and explored new models of drug research and supervision 2 The approved production and marketing of drugs in 2010, a total of 1000 drug registration applications were approved in 2010 Among them, 886 domestic drug registration applications and 114 imports were approved Among the approved drugs, the number of chemicals still ranks first, accounting for 88.9% of the approved drugs, followed by traditional Chinese medicine and biological products Compared with 2009, the total number of approvals increased by 26.2% in 2010, mainly due to the increase in the number of chemical generic approvals Table 1: approved drugs in 2010, registration classification, new drugs, modified dosage forms, generic drugs, imported chemicals, 103 51 640 95 889, traditional Chinese medicine, 12 59 9 18 98, biological products, 12 11 13, 1000 in total note: 1 The data in the table is calculated by acceptance number, which is the number of an application filed by the applicant Number different specifications of APIs, preparations and preparations of each applicant respectively 2 The new drugs in the table are the drugs managed according to the regulations of the measures for the administration of drug registration New chemical drugs include 1-4 registration categories of chemical drugs, and new traditional Chinese medicine includes 1-7 registration categories of traditional Chinese medicine and natural drugs 3 In the table, the chemical drug modified form is classified as chemical drug registration 5, and the traditional Chinese medicine modified form is classified as traditional Chinese medicine and natural drug registration 8 4 The chemical generic drugs in the table are classified as chemical drug registration 6, and the traditional Chinese medicine generic drugs are classified as traditional Chinese medicine and natural drug registration 9 5 Biological products are not classified Figure 1: comparison of drugs approved in 2009 and 2010 among 886 domestic drug registration applications, 794 were chemical drugs, 80 were traditional Chinese medicine, and 12 were biological products There are 124 new drugs, accounting for 14%; 111 modified dosage forms, accounting for 13%; 651 generic drugs, accounting for 73% Table 2: corresponding relationship between domestic drug compound (prescription) and acceptance number registration classification total chemical drugs (compound / acceptance number) 69 / 103 37 / 51 291 / 640 397 / 794 traditional Chinese medicine (prescription / acceptance number) 10 / 12 47 / 59 9 / 9 66 / 80 Figure 2: 2009 and Note for comparison of domestic drugs approved in 2010: calculated by acceptance number Table 3: distribution category of new chemical drugs approved in 2010: 1.523.13.23.3.3.4 other quantity: 21 46 10 53 36 total 103 note: "other" refers to class I, II, III and IV drugs declared according to drug registration management measures (2005 version) Although the duplication of approved varieties has been alleviated in general, some varieties are still concentrated More than 10 varieties approved in this year are: oxygen, Cefmetazole sodium for injection, cefdixone sodium for injection and simvastatin tablets Antibiotics accounted for 6 of the top 10 approved varieties, reflecting that in recent years, drug manufacturers have still invested a lot in antibiotic varieties All of the above antibiotics belong to cephalosporins, floxacin and other conventional categories, and there is no new action type and new target antibiotics According to the classification and statistics of the approved products according to the indication categories, the top 5 indications of the approved products are as follows: Table 4: indication serial number of the approved drugs indication 1: anti infection 2: diabetes 3: cardiovascular 4: respiratory 5: anti-tumor The above data show that in 2010, drug research and development activities maintained a good and orderly trend, and approved the distribution of drugs on the market in multiple treatment areas, providing more drugs and treatment means for clinical medicine 3 Approved drug clinical research in 2010: Table 5: approved drug clinical research in 2010 Registration classification clinical trial bioequivalence test total chemicals 600 180 780 traditional Chinese medicine 55 / 55 biological products 81 /81 total 916 note: calculated by acceptance number Compared with 2009, the number of chemicals and biological products approved for clinical research increased in 2010, and the total number of drugs approved for clinical research also increased Table 6: comparison of clinical studies of approved drugs in 2009 and 2010, registration classification, comparison of chemical drugs in 2009, 2010 and 2009, 627 780 + 24% traditional Chinese medicine, 81 55-32% biological products, 64 81 + 27% total 773 916 + 18%, note: