[MAH] Chinese original medicine bid farewell to the era of selling young crops

On January 12, the State Food and Drug Administration (CFDA) issued a notice approving the listing of domestic generic drugs, such as gefitinib tablets produced by Qilu Pharmaceutical (Hainan) Co., Ltd., yifeiwelun tablets produced by Shanghai desino biomedical Co., Ltd and tenofovir fumarate dipivoxil tablets produced by Chengdu Beite Pharmaceutical Co., Ltd The above-mentioned products are all the first-line commonly used treatment drugs in the relevant treatment fields, and are the first successful drugs imitated in China, basically consistent with the quality and efficacy of the original drugs Another noteworthy point is that gefitinib is also the first pilot drug product approved for marketing in China According to the statistics of CFDA, as of December 25, 2016, 44 pilot varieties of listed holders have entered the stage of listing application In the context of priority review and approval, the time to market of these varieties is around the corner "Scientific research institutions and researchers have more choices than just selling young crops," he said Ding Jian, academician of the Chinese Academy of Sciences and director of the academic committee of Shanghai Pharmaceutical Research Institute, said that with the MAH system pilot, the enthusiasm of R & D personnel has increased significantly At the same time, the cooperation mode between Shanghai Pharmaceutical Institute and enterprises, which are the major producers of domestic scientific research achievements, is more abundant Before 2015, China's drug approval number was only issued to manufacturers with drug production license With the gradual improvement of China's market economy system, the innovation and R & D capacity of the pharmaceutical industry has been continuously enhanced With the growing demand of the people for safe, effective and accessible drugs, the disadvantages of this "bundling" registration management have become increasingly prominent "When a new drug is not sure whether it can be successfully launched, it will not only waste resources, but also kill many promising innovation projects At the same time, there are a lot of domestic GMP qualified production enterprises with a large number of idle capacity " Experts in the industry said that the "bundling system" management has resulted in low-level duplication and weak innovation in drug research and development, low efficiency in industrial allocation, unclear rights and responsibilities of relevant subjects, waste of government administrative resources and other issues In August 2015, the State Council issued the opinions on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), which opened the curtain of deepening the reform of China's drug regulatory system The purpose of this round of reform is not only to solve the practical problems of overstock of review and approval, low quality of application materials and low quality of generic drugs, but also to establish a scientific, effective and perfect drug regulatory system In this regulatory system, the drug listing license holder system is one of its important pillars 　　 Since then, the 17th meeting of the Standing Committee of the 12th National People's Congress "authorized the State Council to carry out pilot drug listing license holder system in ten provinces and municipalities directly under the central government, including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, to allow drug research and development institutions and researchers to obtain drug approval numbers and bear the responsibility for drug quality Corresponding responsibilities " After in-depth study and extensive consultation, the State Council officially released the pilot program of drug listing license holder system (GBF [2016] No 41, hereinafter referred to as the program) on June 6, 2016 Since then, the drug listing license holder system as the key to deepen the reform of drug regulatory system has been on the stage As of December 25, 2016, a total of 165 varieties (calculated by acceptance number) from 10 pilot areas applied for clinical trials, listing applications or supplementary applications Left hand cro right hand CMO "the current mode is left hand cro right hand CMO." Luo Jiali, general manager of Boehringer Ingelheim biopharmaceutical (China) Co., Ltd., said that with the help of the pilot drug listing license system, the R & D and listing of innovative drugs needed by local doctors and patients in China will be effectively promoted, and Chinese patients can get safe and affordable drugs faster "MAH pilot makes drug R & D and production no longer" bundling ", and China's drug production has entered the era of" entrustment ", which is also consistent with the common practice of the developed pharmaceutical industry in Europe, the United States, Japan, etc." Chen Li, founder of Hualing Pharmaceutical Technology (Shanghai) Co., Ltd., told reporters Hms5552, the company's innovative fourth generation glucokinase activator for the treatment of type 2 diabetes, has entered phase II clinical trials, but the company does not have a laboratory or its own production plant Their model is left-handed cro, right-handed CMO, all commissioned "Our personnel are mainly responsible for resource allocation, research quality and risk control in the R & D process." Chen Li said that Hualing medicine has obtained the approval documents of clinical trials in the shortest time and achieved the success of several clinical trials In the first half of last year, Hualing pharmaceutical successfully completed the c-round financing of US $50 million, which means that this R & D mode has been recognized by the capital market "As early as the regulatory authorities have not started, we have started to study the pilot." Chen Yaoshui, deputy director of Shanghai food and drug administration, said that as one of the pilot cities, Shanghai made the implementation plan for Shanghai as soon as possible, and simultaneously issued relevant policy interpretation and guidelines, optimized the acceptance process and strengthened enterprise services In addition, a brand-new risk relief mode of government special funds plus insurance compensation is established by introducing a third party into the society "At present, Shanghai has received a total of 25 application materials for participating in the pilot, involving 15 varieties, of which 6 varieties are global new innovative drugs with independent intellectual property rights." Yan zuqiang, director of the Shanghai food and drug administration, said that according to one of the biological products enterprises applying for the pilot project, once the system of listing license holders is implemented, it will save the company about 500 million yuan of factory building costs, and it is expected that the product listing time can be shortened by 3-4 years What to do after the pilot? Jiangsu Province, a big pharmaceutical Province, also introduced the pilot implementation plan of drug listing license holder system in Jiangsu Province last year, which encourages qualified regions to set up relevant special funds and risk guarantee funds, and gives priority to support in talent introduction, scientific research project approval and achievement transformation Wang Zongmin, director of the drug registration office of Jiangsu food and drug administration, told reporters that Jiangsu Province held four symposiums to listen to the opinions of all parties on the pilot work, focusing on the study of the "letter of commitment on drug clinical trial risk responsibility", "letter of commitment on drug quality and safety responsibility" and other elements as well as the regulatory requirements for listed holders According to reports, 21 varieties in Jiangsu Province have submitted 38 applications for registration, while 148 varieties are willing to carry out pilot projects according to the province's investigation During the visit, the reporter obviously felt the appreciation of pharmaceutical companies for the listing permission system, many of them were eager to try, but there were some doubts At present, many local pilot implementation schemes have been introduced, but they are basically to encourage enterprises to transfer or entrust each other among local enterprises So, what if one of the two enterprises belongs to the pilot area and the other belongs to the non pilot province? In addition, what if the pilot is over, but the product has not been approved? What are the requirements of the applicant, the holder and the entrusted production enterprise? How to ensure that someone has the ability to take responsibility for drug quality and safety? These problems still need to be solved in practice and further clarified On January 9, with the approval of Premier Li Keqiang, the State Council officially printed and issued the 13th five year plan for deepening the reform of the medical and health system (hereinafter referred to as the plan) Establishing a standardized and orderly drug supply and security system is one of the five key points of the plan "Accelerating the consistency evaluation of quality and efficacy of generic drugs, encouraging the creation of new drugs, encouraging drug innovation guided by clinical value" and "establishing the drug marketing license holder system" are highlighted again in the planning "The spring of new drug R & D and innovation has come." In interviews with reporters in Jiangsu, Shanghai and other places, pharmaceutical entrepreneurs have sighed.