Look at each other coldly! Thinking about a list of children's drugs

One year later, the national health and Family Planning Commission, together with other relevant departments, released the second list of children's drugs to encourage R & D Application on May 12 There are 72 varieties involved in the first two batches, which is not small I wanted to roll up my sleeves and do a big job, but I took this list and sat down to think calmly, but I felt I had no clue It is an indisputable fact that pharmaceutical companies are not interested in children's medicine As early as the first list came out, the drug Rubik's cube used the database to make an inventory (see: the health and Family Planning Commission / CFDA encouraged the development and application of 32 kinds of children's drugs (with the application information, list of beneficiary enterprises)), and felt a shiver at a glance, with few applicants Why is the industry still indifferent to the favorable policies? Here, in order to lovely children, especially the path of children's drug industrialization is discussed, hoping to cause thinking and action from all walks of life As you all know, the pharmaceutical industry covers a wide range of areas, including not only academic and industrial, but also business and ethics There are many laws, regulations and guiding principles to regulate every link of pharmaceutical industry It is a long chain for every drug to be used by patients from scratch until the patient's condition improves and finally returns to health No lack of any drug can achieve the goal of health The introduction of a list of encouragement has condensed the efforts of the competent authorities and experts and scholars It has to be said that this has been a great progress However, as mentioned above, more and clear policies are needed to guide the industry to forge ahead in order for the industry to respond to the call of the state and truly realize the mission of this list Existing incentive policies for children's drugs priority review policy for children's drugs August 18, 2015 The opinions of the State Council on the reform of the review and approval system for medical devices of drugs and especially pointed out that "accelerating the review and approval of innovative drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases, rare diseases and other diseases, drugs included in the major national science and technology projects and national key R & D plans, and drugs transferred to innovative drugs produced in China and drugs used by children" As well as the use of advanced preparation technology, innovative treatment means and innovative drugs with obvious treatment advantages On November 11, 2015, the announcement of the State Food and Drug Administration on several policies for drug registration review and approval was issued The original measures for drug registration management began to be drastically reformed It was clearly pointed out that eight kinds of eligible applications for drug registration, including "children's drug application", should be queued up separately to speed up the application for drug registration On January 29, 2016, the drug examination center issued the basic principles for the evaluation of the application for priority review and approval of children's drug use in clinical urgent need and the first batch of children's drug use varieties catalogue determined based on the principles Previously, the center for drug review asked for social opinions on December 21, 2015 On February 26, 2016, the opinions of the General Administration on solving the backlog of drug registration applications and implementing the priority review and approval put forward drug registration applications with obvious clinical advantages in the scope of priority review and approval, including "drugs for children" The priority review rules for children's drugs include: after the registration application is transferred to the drug review center, the applicant shall submit the application for priority review and approval to the drug review center through the "applicant window", indicating the variety information and the reasons for inclusion in the priority review and approval The drug Audit Center shall organize experts to audit and demonstrate every month, and publicize the audit results and reasons as well as the specific information of the varieties proposed for priority review In the process of technical review, if it is found that the application materials of the varieties included in the scope of priority review and approval can not meet the conditions of priority review, the drug review center will terminate the priority review of the varieties and return them to the normal review sequence to queue up again As for the application of generic drugs urgently needed in clinic and short of market, from the date of the company of this variety, the application for priority review and approval of new application varieties with the same active ingredients and routes of administration will not be accepted For the imported children's drugs that are clinically needed and have been listed in the United States, the European Union and the surrounding areas of China, the relevant clinical trial data completed overseas can be used for drug registration application in China The above four documents, from the State Council to the State Administration, have made clear the status and Implementation Opinions of priority review and approval of children's drugs Encouraging policies for children's drug research and Development released on July 11, 2014 technical guidelines for pharmacokinetic research in pediatric population to standardize and guide pharmacokinetic research in pediatric population This guiding principle has been first draft, final draft and draft for comments since the first half of 2013, and has been officially released and implemented for more than one year On August 4, 2015, the notice on Soliciting Opinions on technical guidelines for clinical trials of paediatric population was issued, aiming to further promote and standardize the clinical trials of paediatric population in China, improve the research quality of clinical trials of paediatric population in China, so that the research data can fully support the research and development of new paediatric drugs and avoid unnecessary repeated research The guidelines have not yet been formally released and implemented 2016 3/4 In order to encourage the creation of new drugs, strictly review and approve, improve the quality of drugs, promote industrial upgrading, reform the current registration and classification of chemical drugs, classify drug registration applications into innovative drugs, improved new drugs, generic drugs and imported drugs, and adjust the new drug monitoring period On March 3, 2017, the notice on Soliciting Opinions on technical guidelines for non clinical safety research of pediatric medication was issued, aiming to further encourage the development of pediatric medication, ensure the safety of child subjects, and clarify and unify the technical requirements for non clinical safety evaluation of pediatric medication The guidelines have not yet been formally released and implemented 2017 5/11 The announcement of "relevant policies on encouraging the innovation of pharmaceutical medical devices and accelerating the review and approval of new drug medical devices on the market" (Draft for comments) was issued, and it was proposed that "the early and mid-term indicators of clinical trials of pharmaceutical medical devices that are of great significance for the treatment of diseases that are seriously life-threatening and have no effective means of treatment and other pharmaceutical medical devices that address clinical needs are shown If the curative effect can be predicted and its clinical value can be predicted, it can be approved for marketing conditionally " On May 12, 2017, the notice on the opinions of relevant policies on encouraging innovation of pharmaceutical medical devices to protect the rights and interests of innovators (Draft for comments) was issued to further deepen the reform of review and approval system, promote industrial restructuring and technological innovation of pharmaceutical medical devices, improve industrial competitiveness, and meet the clinical needs of the public It puts forward the data protection system of drug test, which "belongs to the innovative drug, the rare disease drug and the special drug for children, with a 10-year data protection period; belongs to the improved new drug, the rare disease drug and the special drug for children, with a 3-year data protection period" On May 18, 2017, the technical guidelines for extrapolation of adult medication data to paediatric population was released, encouraging the development of paediatric medication, maximizing the use of existing data, reducing unnecessary paediatric research, improving and enriching the medication information of paediatric population in the instruction manual through data extrapolation, and guiding clinical medication This guiding principle provides practical value for clinical remission in the process of research on children's drug use Children's drug pricing, medical insurance and procurement policies are very concerned about children's drug pricing, medical insurance and procurement issues, and three documents also put forward relevant guiding opinions 2014 5/30 The national health and Family Planning Commission, together with the national development and Reform Commission and other six ministries and commissions, issued several opinions on the protection of children's drug use, in which in addition to the consistent emphasis on accelerating the review and encouraging innovation, it was specially pointed out that "policy support should be given to the price of children's drug use, and the special dosage form for children can be listed as a single generation of table products, which is not affected by the pricing level of adult drugs; the research provisions on the appropriate dosage form for children are relatively wide Loose dosage form price comparison coefficient "and" give full play to the medical insurance's guarantee function for children's drug use, and timely include children's appropriate dosage forms and specifications into the payment scope of basic medical insurance according to regulations " On February 28, 2015, the general office of the State Council issued the guiding opinions on improving the centralized procurement of drugs in public hospitals, which "centralized Internet access and direct procurement by hospitals" were implemented for pediatric non patent drugs 2015 9/2 The national health and Family Planning Commission issued the notice on Further Strengthening the use of children's drug use in medical institutions, which requires that "children's drug use should meet the needs of children of different ages, which belongs to the use of other dosage forms and dosage specifications due to special diagnosis and treatment needs All medical institutions should relax the restrictions on the allocation of suitable varieties, dosage forms and specifications for children", and emphasize again“ Direct online procurement " Listed above many policy documents, you can see that the drug regulatory department has done a lot of work in the research and development, registration application, review and approval of children's special drugs, but there are no more clear operational documents in the drug market circulation Achievements of the work of the drug Audit Center: after the National Bureau issued the policy of "children's drug use" registration application queuing separately on November 11, 2015, many enterprises responded, and the drug audit center also acted quickly, publicized to the society on December 21, and determined the first batch of priority review items list on January 29, 2016 High efficiency, praised by the National Bureau Although the application for chlorfarabine production of Beida Pharmaceutical Co., Ltd has obtained the priority review, it has been withdrawn in October 2016 in accordance with the relevant requirements of the announcement of the State Food and Drug Administration on matters related to the re declaration of withdrawn varieties through self inspection and verification of drug clinical trial data (2016 No 113) Chengdu Yuandong's caffeinated citrate injection has been listed as an imported product, which belongs to generic drugs and does not need to be clinical It was approved to be listed in the year of priority review (October 2016), and a launch conference was held in December In addition to the spring breeze of preferential policies, Chengdu Yuandong is more important to reflect its own R & D registration strength As early as 1999, the children's use of lopenan sodium dry syrup was approved in Japan So far, it has more than ten years of clinical use history and accumulated a large number of clinical data In February 2016, the National Bureau proposed that "for the imported children's drugs that are clinically needed and have been listed in the United States, the European Union and China's surrounding areas, the relevant clinical trial data completed overseas can be used for drug registration application in China" Japan is a neighboring country of China, which belongs to yellow race in terms of race Therefore, the clinical trial data obtained in Japan for children's use of lopenan sodium dry syrup can be used to apply for drug registration in China It can be seen that maruhong in Japan seems to have taken a shortcut After the clinical application was given priority review in January 2016, the class 5.1 import application of maruhong's children's faropenem sodium granules continued to be given priority review on the basis of children's drug use in January 2017 In contrast, propranolol hydrochloride oral solution, although oral solid preparations have been on the market for many years in China and accumulated rich clinical data and use experience, but the oral solution is not on the market and there is no adult drug data