The National Health Commission announced that a total of 32 pediatric medications have been approved for market use, among which 16 are designated for rare diseases.
On December 6, the National Health Commission held a press conference to introduce the technological innovation in the pharmaceutical sector and answer questions from reporters.
Wang Xuetao, Deputy Director of the Drug Policy Department of the National Health Commission, stated that in recent years, the commission has focused on assessing the demand for clinical medications. This has primarily been achieved by developing lists that encourage the research and development of pediatric drugs and directories for encouraging generic drugs, strengthening inter-departmental collaboration on drug policies, and guiding and supporting the innovation and supply of pharmaceuticals to better meet the urgent clinical needs for suitable medications. There are three main initiatives:
First, in encouraging the research and development of pediatric drugs. In accordance with the requirements to enhance pediatric medication efforts, the commission has continuously enriched the variety, dosage forms, and specifications of drugs suitable for children to meet the clinical medication needs in pediatrics. Since 2016, the National Health Commission, in collaboration with relevant departments, has formulated and released five batches of a list of 144 drugs that encourage research and development for pediatric use. Currently, 32 drugs have been approved for market release, including 16 for rare diseases, such as clobazam tablets for treating children with rare refractory epilepsy.
Second, in enhancing the supply assurance capability of generic drugs. The National Health Commission, in conjunction with relevant departments, organized experts to review and select domestic drug patent situations and drugs with clinical supply shortages and insufficient research and production motivation. Three batches of a directory encouraging generic drugs have been formulated and released, totaling 89 varieties. So far, 33 varieties have been approved for market release, with 10 filling domestic treatment gaps and 5 filling gaps for domestically produced drugs, such as posaconazole injection for the treatment and prevention of invasive aspergillosis.
Third, in improving policies that encourage drug research and development. The National Health Commission emphasizes strengthening inter-departmental collaboration, establishing mechanisms for information sharing, communication, and collaborative innovation across departments. The varieties listed in the aforementioned lists and directories are prioritized for support in national major projects, expedited review and approval processes, and prioritized inclusion in the National Essential Medicines List and the National Basic Medical Insurance Drug List, thereby better guiding enterprises to conduct research and development based on clinical needs. Additionally, the National Health Commission conducts annual dynamic assessments of these two lists to promote the coordination and alignment of policies encouraging research and development and generic drugs.
