National Food and Drug Administration: 14 children's medicines have been approved for marketing in 2021
Date:2021-07-28 origin:China Industry News Visit:13460
Jiao Hong requires in-depth investigation and research to understand urgent clinical needs and corporate R&D challenges, promote the strengthening of the coordination of production, education, research and application of children's drug use, and establish a sound coordination and cooperation mechanism. It is necessary to strengthen the research and use of real-world data, combine clinical practice, learn from international experience, concentrate the wisdom of experts, and boldly explore and practice, and build an evaluation evidence system that supports the development of children's drug use with real-world data. It is necessary to make good use of relevant policies for priority review, review and approval, learn from the experience of emergency review and approval of anti-epidemic-related vaccine drugs, further improve the guiding principle system, stimulate innovation vitality, better guide scientific research and development, and promote the faster launch of clinically needed drugs and innovative drugs . We must uphold an open attitude, listen to the voice of the industry, strengthen policy interpretation and publicity, promote the same direction of industrial forces and regulatory agencies, and promote the co-governance of children's drug use in society.
It is reported that encouraging and supporting the research and development of children's drugs is an important part of the National Medical Products Administration's Party Leadership Group's "I do practical things for the masses" practice activities. Supporting the research and development of strict supervision of children's drugs is the National Drug Administration's "Top Ten Projects for Benefiting Enterprises and People in Drug Supervision" "one. In 2020, the State Food and Drug Administration approved a total of 26 special medicines for children and increased medicines for children, an increase of 36.8% year-on-year. In 2021, the development and review and approval of children's medicines will continue to grow. At present, 14 children's medicines have been approved for marketing, and dozens of children's medicines and varieties with increased children's indications or dosages are under review, of which 22 This variety has been included in the priority review and approval sequence.
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