Health and Family Planning Commission: explore the pilot import of drugs urgently needed by children in Hong Kong, Macao and Taiwan

Source: Netease News 2016-06-03 Chinese government issued the list of the first batch of drugs to encourage research and development and application for children on June 1 The head of the relevant department of the health and Family Planning Commission said that a special channel will be established for the application and review of the drugs involved in the list For children who have been used in Hong Kong, Macao and Taiwan for many years, have good clinical efficacy and use safety, but have not been listed in the mainland, they need to explore the pilot import and use When registering and reviewing the imported children's drugs, they are allowed to directly use the clinical drug data of children in Hong Kong, Macao and Taiwan As the basis of application, accelerate the review and approval At present, China's children's health and drug use level continue to improve, and the basic drug use situation gradually improves, the person in charge said However, there are still some problems, such as the lack of suitable dosage forms and specifications for children's drugs, the lack of enterprise R & D and production power According to the clinical needs, the state has combed out the specifications of suitable dosage forms of children's drugs that have been listed abroad but not yet registered in China, and formulated this list This will be conducive to guiding the research and development of children's drugs, guiding enterprises to organize production reasonably, highlighting the key points of application and evaluation of appropriate dosage forms and specifications for children, better meeting the needs of pediatric clinical drug use, and improving the level of Chinese children's drug use According to the person in charge, relevant departments will give policy preference to the research and development application of the drugs in the list Through the national "major new drug creation" major science and technology projects, major innovation and development projects of protein biopharmaceuticals and vaccines, they will integrate superior units to cooperate in innovation and research, guide and encourage enterprises to give priority to research and development and production In addition, the health and Family Planning Commission, together with relevant departments, will organize experts to formulate a new list of drugs to encourage research, development and application of children's drugs, which will be released to the society in a timely manner.