? Six departments issued security children use the new policy
? Children's medicine "by hand" is expected to end
recently, by the State Council, the national health and Family Planning Commission and other six departments jointly issued the "opinions" on the protection of children, which is nearly 10 years our country about the children's first comprehensive guidance document. This means that, in the future there will be more enterprises for children "tailored" appropriate dosage forms and specifications of drugs, child dress and children's drug R & D and production will be encouraged and support policy, so as to realize the "good medicine not bitter, not by quantitative", long troubled cheapjerseys.us children's medicine "in parents of children with hand breaking" is expected to end.
children are not "miniature version of the adult"
years, the enthusiasm cheap mlb jerseys of enterprises producing children is not high, the suitable dosage forms and specifications of children lack of drug. At the same time, children's drug instructions describing vague. For example, many of the drug instructions only "children with caution or reduction" "to follow the doctor's advice" to describe, the lack of clear children indications and usage, has not been cheap nba jerseys clearly marked adverse reaction of warning information, clinicians can only with experience in clinical practice medicine. Some parents of children lack of scientific knowledge, not suitable for children to form, specifications of the drug, often simple from the individual medication experience decide to reduce cheap nfl jerseys the dosage or change the mode of administration, not only difficult to accurately control the dose, influence drug efficacy, also brings risks. In addition, some expensive drugs, such as injection drug use lack of child appropriate specifications, each will only adult dose, specifications and packaging to split. Use less, throw, resulting in waste, increased drug costs and the burden of patients.
National Health Planning Commission drug policy and basic drug system division director Zheng Hong points out, children are often referred to as "little adults", but in the drug must not be simply regarded as "miniature versions of adult". In the future, with the "opinions" issued, will further regulate the administration of medicine to children.
children's drug approval will be "Easy Access"
"Opinions" put forward for, part of clinical need children suitable varieties, dosage form, specification, a review of the declaration specifically channel, accelerate the progress, and gradually establish encourage R & D children drugs directory, guide and encourage enterprises to give priority to R & D and production. To encourage children's drug clinical trials. To strengthen children's drug clinical trial management, promote the clinical test platform construction and team construction, improve the subjects' participation. To explore the clinical trial data and provide related children drug information to establish the system of new drug application. For the listed species, the requirements of the production enterprises to improve children's clinical trial data.
the State Food and Drug Administration drug cosmetic registration management division deputy researcher Xu Xiaoqiang said, for children, China will establish the declaration review special channel. The foreign listed domestic use but lack and clinical need suitable for children, dosage form, specification variety, speed up the declaration review schedule. Now the number of pharmaceutical enterprises to declare a lot, a large number of applications in the pending queue, queue sequence according to the normal, may cheap jerseys have to go through a long >
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