echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > "People's Daily": paediatric drug approval to improve efficiency!

    "People's Daily": paediatric drug approval to improve efficiency!

    • Last Update: 2017-11-28
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: the report of the 19th National Congress of the Communist Party of China on November 28, 2017 proposed to improve the drug supply guarantee system In recent years, in view of the shortage of children's drugs and the lack of motivation for research and development, with the key support of the party and the government, the priority evaluation system for children's drug use in China has been continuously improved, the guarantee for children's drug use has been strengthened, and the level of pediatric drug use has been continuously improved "In the past, clinical approval documents for children's drug use usually took about 2 years, but now it only takes 4-6 months Since 2016, we have obtained three clinical approval documents of children's drugs, and the enterprise has really felt the acceleration of review and approval of children's drugs " Ding Yang, deputy general manager of R & D center of Sichuan Baili Pharmaceutical Co., Ltd According to the latest statistics of the drug review center of the State Food and Drug Administration (hereinafter referred to as the drug review center), up to now, 353 registration applications (calculated according to the acceptance number) have been included in the priority review procedure in the list of priority review and approval drugs, 40 of which are children's drugs, accounting for 11.33% of the priority review and approval drugs There are 12 indications involved in the drug use for children included in the priority review, most of which are endocrine system drugs for children's diabetes, and other critical diseases such as childhood leukemia, hemangioma and neonatal apnea Some children's drugs with clinical value and urgent need of patients have completed the technical review before being put on the market, such as megestat capsule for the treatment of rare disease C-type nematic peak disease, tobramzumab injection for the treatment of systemic juvenile idiopathic arthritis, and injection glucosidase for the treatment of Pompeii disease Why is it difficult to develop drugs for children? In recent years, children's drug use has attracted social attention From the perspective of the commercial value of drug manufacturers, the number of adult new drug patients after marketing is large and the commercial return is fast; while the number of children drug patients is small and the commercial return is low, and the input and output are often inverted Therefore, the motivation of drug research and development in children is insufficient "The development of drugs for children is a worldwide problem In most cases, it's more difficult for children to participate in clinical trials than for parents to participate in clinical trials themselves " Yang Zhimin, director of the clinical department of chemotherapeutics of the drug Audit Center, said, "there are many problems to be solved, such as difficult recruitment of subjects, many ethical issues involved, many safety concerns and high requirements for evaluation methods of pediatric research." In addition, the research and development of drug use for children in China also faces special problems There are no research and development institutions specialized in children's drug use in China, and even the vast majority of research and development institutions do not have children's drug research and development personnel, resulting in low research and development ability Compared with the European and American countries, the innovation ability of pediatric clinical trials in China is insufficient Even if the European and American children have been listed in the market, the imitation ability in China needs to be improved The head of the drug Audit Center said that in the face of the new situation of opening up the two child policy, it is urgent to solve the problem of drug use for children Since the reform of drug review and approval system initiated by the State Council, the drug review center has adhered to the guidance of clinical needs, actively improved the system of drug priority review for children, and responded to social concerns How to improve the speed and quality of evaluation? "Shenzhen Children's hospital received an 8-month-old child with erythema and arthritis It was diagnosed as "systemic juvenile idiopathic arthritis" Fortunately, the trodzumab injection has been approved for marketing through the priority review, and the child was saved in time After the implementation of the priority review policy for encouraging children to use drugs in 2016, the drug officially entered the green channel and was approved for marketing in only 8 months " Yang Hong, registered director of Shanghai Roche Pharmaceutical Co., Ltd Since 2015, the drug Audit Center has implemented a series of new policies on drug priority review for children "As an important part of the reform of drug review and approval, the drug review center attaches great importance to children's drug use and strives to solve the problem of children's drug use." Yang Zhimin said Establish and improve a scientific technical evaluation system The drug Audit Center has issued four technical guidelines, including the guiding principles for clinical drug trials in pediatric population, and gradually established and improved a scientific evaluation system for children's drug use technology "In the past, there were no guiding principles and enterprises had no sense of direction Now we have made clear the 'rules of the game' Enterprises have more time foresight and quality foresight to declare, and their efficiency and confidence have been greatly improved." Yang Zhimin said Children's drug use reviews are queued separately "In the past, drug use in children was reviewed together with drug use in adults, and there was a backlog Now children's drugs are separated, and priority is given to review " Yang Zhimin said, "while insisting on the green light review of the drug varieties for children, we will work with the research and development scientists team to promote the enterprise's research and development process, so that the children's drugs urgently needed in clinical and in short market can be put on the market as soon as possible and serve children's patients." Inspired by the policy of priority evaluation of children's drug use, the enthusiasm of drug giants who were not willing to do clinical trials for children in China has increased, and the number of children's clinical trials approved has increased significantly The review speed has been raised Is the review quality guaranteed? Ding Yang believes that the speed-up is mainly due to the optimization of the system The review experts of the drug review center participated in the whole process of children's drug priority review, saving a lot of time and investment for the enterprise, not only not sacrificing the review quality, but also helping the enterprise to improve the level of clinical research, driving the healthy development of children's drug research and development China's children are gradually saying goodbye to the era of "drug shortage" What will be the changes in children's medication? "My son has diarrhea The doctor said that it's OK to take some rehydration salt But most of Beijing drugstores are adults' rehydration salt There is no special rehydration salt for children It's difficult to control the proportion and dosage if you want to wash it with water." Zhou Jun, a young mother in Chaoyang District, Beijing, said, "later, I bought children's rehydration salt from abroad, without making any adjustments The lid is a measuring cup, and there are strawberry, watermelon and other flavors, which are more acceptable to children." Children's medicine needs to be "delicious" The improvement of dosage form is one of the important contents of drug use evaluation for children in China In our country, there is a lack of various forms of children's drug use, especially suitable dosage forms designed for children of different ages Some compounds have special physical and chemical characteristics When developing dosage forms suitable for children, especially for infants, they have special safety requirements in excipients, which makes it difficult to achieve technically "Some foreign children's drugs not only have dosage forms and tastes suitable for children, but also design cartoon droppers to help parents to accurately quantify, so that children's drugs are not only safe but also interesting, which is worth our reference." Yang Zhimin said Children need to be quantified "Children's discretionary reduction" is a common medication guidance in the drug use manual "In fact, the amount of drugs used by infants, young children and teenagers is totally different To guide families to use children's drugs in a standardized way, more detailed information on children's drugs should be included in the instructions " "In the future, if a foreign drug manual has instructions for children's use, we will also improve the Chinese manual system after scientific evaluation," Yang said Children's medication needs innovation The drug audit center actively built a platform, implemented the mode of "early intervention, service innovation", held an exchange meeting with the declaring pharmaceutical enterprises, and jointly discussed the safety indicators and schemes of the declared varieties Yang Zhimin called for further strengthening international exchanges and cooperation, accelerating the introduction of new international children's drugs and new clinical research methods, and gradually realizing the synchronization of children's drug evaluation, marketing and international, so that our children can benefit from the latest research results of the world, and truly provide health protection for the next generation.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.