CDE Yang Zhimin, Xie Songmei: Drug review promotes the development of pediatric drugs through multiple channels, and product reviews are gradually increasing!

The issue of child medication is a livelihood issue that the party and the state attach great importance to, and General Secretary Xi Jinping has issued important instructions on this issue many times

During the interview, the reporter learned that the drug risporan oral solution for the treatment of rare diseases was launched in the first half of 2021 and was approved for the treatment of spinal muscular atrophy (SMA) in patients aged 2 months and older

She said: “Through early communication in clinical research and development, we recommend that the original research company conduct clinical trials in China as soon as possible to provide data support for scientific decision-making in drug review

Publish a list of encouraged R&D

Yang Zhimin, director of the Department of Clinical Medicine of the Center for Drug Appraisal, pointed out: "To promote the solution of children's drug use problems, regulatory agencies, clinical institutions and drug manufacturers need to work together in the same direction

In recent years, with the support of major national science and technology projects, a number of children's medical institutions in China have established a relatively complete research and development technology platform for children's drugs, which provides a strong guarantee for the innovative research and development of children's drugs in China

"The review of children-first and urgently-needed varieties has its own particularities.

In order to improve the efficiency of variety review, minimize review time, and accelerate the launch of children's drugs, the Center for Drug Evaluation has also set up a special label for "Children's Drugs", which will be connected by a project manager to supervise the review progress and ensure progress in time

Data shows that among the three batches of clinically urgently needed overseas new drug catalogues released by the National Health and Construction Commission, 16 new drugs that are urgently needed for clinical use in children have been approved for marketing

   As of June 30, 2021, 14 varieties on the list have completed technical review and been approved for marketing, 9 varieties on the list are under review for marketing applications, and 5 varieties on the list have been approved for clinical trials

Improve the review standard system

  The formulation of technical guidelines is an important supervision method for regulating drug research and development and improving the quality and efficiency of drug research

  It is understood that before 2020, the Center for Drug Evaluation only issued three specific guidelines for children's medication

  This year, the Center for Drug Evaluation also published the "Technical Guidelines for the Clinical Trials of Modified New Drugs for Children's Chemicals", "Technical Guidelines for the Writing of Children's Drug-related Information in the Instructions for Chemicals and Biological Products for Treatment", and "Clinical Trials of Attention Deficit Hyperactivity Disorder Drugs" A total of 4 technical guidelines are included in the annual plan

  In addition, in order to standardize the standardization and supplementation of children's drug information in the labeling of listed drugs, the drug review center makes full use of the data resources of children's medical institutions, adopts real-world research methods, follows review technical standards, organizes expert demonstrations, and publicly solicits opinions.