Children's medicine 'legalization' to accelerate the layout of drug companies

The newly revised Drug Administration Law will come into force on December 1, 2019. The new version of the Drug Administration Law formally includes "medicines for children", specifying that the state will take effective measures to encourage the development and innovation of medicines for children, support the development of new varieties, dosage forms and specifications of medicines for children that meet the physiological characteristics of children, and give priority to the review and approval of medicines for children.

Children's drugs are given priority for review and approval. China's children's drug market size of more than 100 billion yuan, the number of children's outpatient clinics has been in the growth trend, but the market size of children's drugs accounted for only 5% of the pharmaceutical industry, at the same time, children's drugs for a long time there are few varieties, dose ambiguity, lack of specifications and other problems. Previously, the "Drug Administration Law of the People's Republic of China" and "Drug Registration Management Measures" did not put forward special provisions for children's medication. In the industry's view, the formal inclusion of children's medicine in the new version of the Drug Administration Law is the official opening of the prologue of the "legalization" of children's medicine. Yang Jie, president of Dain Pharmaceutical Group, pointed out that the relevant state departments have formulated and issued a series of policies and regulations to protect children's medicine, which has greatly promoted the development of the children's medicine industry, and also promoted the development of enterprises in drug development and creation, review and approval, and production.