The list of first batch of children's drugs to encourage research and development is in cold weather: Why are enterprises not invested in policy support?

Source: Medical Economic News May 18, 2017, medical network, one year later, the health and Family Planning Commission issued the "second batch of recommendations for encouraging research and development of children's drugs" on May 12, 2017 In May 2016, the health and Family Planning Commission published 32 drug lists, and the second batch published 40 drug lists However, even if the health and Family Planning Commission issued the pediatric encouragement catalogue from the clinical demand level, when the research and development policy of children's drugs is not clear, the manufacturers may not be willing to invest resources First batch analysis: up to 25% of the expected industrialization? Among the 32 products, zuoxiracetam injection jointly declared by Chengdu Tiantaishan Pharmaceutical Co., Ltd and Sichuan dingnuotaichen Technology Co., Ltd is on the "list of the first batch of drugs to encourage research and development and declaration for children", and it was listed as the "drugs to be included in the priority review procedure" list by CDE in September 2016 According to the column of CDE included in the list of priority review varieties on May 5, 2017, only the concentrated solution for injection of levetiracetam of youshibi Trading (Shanghai) Co., Ltd was finally reviewed in priority Both the concentrated solution for zuelacetan injection of youshibi and zuelacetan injection of Chengdu Tiantaishan Pharmaceutical Co., Ltd belong to the first batch of products in the self-examination list They have successively entered the announcement of the on-site verification plan for clinical trial data (No 7) and the announcement of the on-site verification plan for clinical trial data (No 8), but there is no approval result Zuelacetan injection is in the There is no product on the market in China As shown in Table 1, among the first batch of products that are encouraged to develop and apply for children's drug list, except sodium bicarbonate injection, which was applied for supplementary application by manufacturers in 2016, there are no new registration applications for other products after 2016 Considering the previous application records, the first batch of products encouraging the research and development of children's drug list may be approved for production, including propranolol oral solution, diazepam rectal solution, nimodipine oral solution, recombinant human parathyroid hormone for injection, recombinant human glucagon polypeptide injection, adrenaline hydrochloride injection, sodium bicarbonate injection and levetiracetam injection Products, that is, only 25% of products are likely to enter the industrialization It can be seen from the side that although pediatric products are strongly supported by policies, few manufacturers are willing to invest in them Table 1 status quo of the first batch of products encouraging R & D and declaration of children's drug list (data source: Xianda data v3.2) the second batch of trends: will they repeat the first batch of mistakes? After selecting 10 potential products from 40 products, the author found that 10 products mainly come from the drugs for digestive system diseases, cardiovascular system diseases, endocrine system diseases and antibiotics It can be seen from table 2 that cyclophosphamide tablets of Tonghua Maoxiang Pharmaceutical Co., Ltd have been listed for 50mg, and the company only needs to supplement and declare 25mg ASTA medica has been listed in the market AG, Shanghai Fahrenheit pharmaceutical Tianping pharmaceutical factory, Gongzhuling Hongguang pharmaceutical factory, Nantong essence pharmaceutical company, Jilin Huinan Changlong biochemical pharmaceutical industry, Shanxi taasheng pharmaceutical, Guangzhou Baiyun Mountain Guanghua pharmaceutical, Chaoyang Fuxiang pharmaceutical, Liaoning Ludan pharmaceutical and Tonghua Maoxiang pharmaceutical The above manufacturers did not register this product again, resulting in the product dosage form exclusive Desmopressin acetate spray was approved in 2005 but has not been declared for production To sum up, in the past registration and declaration of the above products, even the more popular chemical drugs, but the dosage form is more biased, and the number of declared manufacturers is not large According to the current status of application, the second batch of recommendations for encouraging research and development of children's drugs may still be cold Table 2: the second batch of recommended list of children's drugs encouraged to apply for research and development has the most potential application status (data source: Xianda data v3.2) There are few child drug projects: the guiding principles of clinical trials have not been issued yet since 2015, the CFDA reform has been accompanied by strong support for children's drug research and development It can also be seen from the announcement of the General Administration of the people's Republic of China on Soliciting Opinions on "relevant policies on encouraging innovation of drugs and medical devices to protect the rights and interests of innovators (Draft)": for innovative drugs approved for marketing, a 6-year data protection period will be given; for those drugs that are not only innovative drugs but also rare disease drugs and children's special drugs, a 10-year data protection period will be given; for those rare diseases that are improved new drugs, a 10-year data protection period will be given Drugs and special drugs for children shall be given 3-year data protection period "Opinions of the General Administration on solving the backlog of drug registration applications and implementing the priority review and approval" the scope of the priority review and approval includes drugs for children In terms of drug procurement, "guidance of the general office of the State Council on improving centralized drug procurement in public hospitals" women's and children's specialty non patent drugs are temporarily not included in the drugs purchased through bidding, but directly purchased on the Internet, which is the state's support for children's drugs in terms of drug price and availability of drug supply However, the research and development of children's drugs are not improving, the key point is that clinical trials are difficult to carry out In 2015, we asked for opinions on "technical guidelines for clinical trials of pediatric drugs", "technical guidelines for extrapolation of adult drug use data in clinical trials of pediatric drugs and the use of relevant information" in 2016, and "technical guidelines for non clinical safety research of pediatric drugs" in 2017 The technical guidelines for the past three years have not been officially published In the consultation draft of "technical guidelines for clinical trials of drugs in pediatric population", the informed consent part requires the informed consent of parents / legal guardians, as well as the informed consent of pediatric subjects, which means that the informed consent of parents / legal guardians is difficult to be obtained for general diseases unless children's patients are rare or in urgent need of new drug treatment "Technical guidelines for extrapolation of adult drug use data in pediatric clinical trials and the use of relevant information" is still asking for opinions, and there are no guidelines for children's drug use that can be exempted from clinical use Therefore, manufacturers are more wait-and-see than invest in children's drugs Summary: when the R & D policy is not clear, even if the health and Family Planning Commission has issued the paediatric encouragement catalogue from the clinical demand level, the manufacturers may not be willing to venture into the resources The market expectation and R & D difficulty are the concerns of manufacturers In 2017, the second batch of products promoted in the catalogue have more potential than the first batch If the R & D policies for children's drugs are more clear in 2017, it is expected that more enterprises in the second batch will be willing to project.