Experts call for specialization of children's drug approval

2013-06-05 source: the press conference of "three dolls · Aizi prescription children's drug safety white paper" sponsored by China care for the next generation working committee, guided by Southern Institute of pharmaceutical economics and organized by Guangzhou Wanglaoji Pharmaceutical Co., Ltd was held in Guangzhou recently According to the report, only 68% of the Chinese public are satisfied with the current drug safety of children The white paper suggests that the relevant departments should set up a special approval department for children's drugs and separate the approval of children's drugs and adult drugs It is also suggested that the national catalogue of essential drugs for children and the management and regulation of clinical drug use for children should be published as soon as possible, and the detailed policies and rules on bidding, pricing and medical insurance for children's drugs should be formulated at the same time, so as to finally issue the children's health law It is reported that the adverse drug reaction rate of neonate reached 24.4% The white paper was compiled by investigating 3368 parents of children in 2 municipalities and 12 provincial capitals, interviewing in-depth experts in laws and regulations, drug research and development, and pediatrics 51% of parents think that children's medication is generally safe, and 7% of parents clearly say that they are not safe for the current overall use of children's medication Zhang Buyong, head of the research group, pointed out that according to the above survey results, the drug safety index of Chinese children was 68% Statistics also show that the incidence of adverse drug reactions in children is about 12.9%, and that in newborns is 24.4%, which is two times and four times higher than that in adults The report points out that as of January 2013, there are more than 180000 domestic drug approvals in China, of which only 3000 are dedicated to children, involving more than 400 varieties "Of the more than 400 varieties, there are only 100 dosage forms for children, especially few liquid preparations for children's drug use There is a significant gap between China's research and development of children's drug use and the international level," Zhang said It calls for the establishment of a special approval department for children's drugs "in terms of policies, China's children's drug research started late, laws and policies are not perfect; in terms of enterprises, it is difficult to develop, research and development costs are high, pricing advantages are not obvious, only the clinical trial of children's drugs, which makes many pharmaceutical enterprises flinch from using children's drugs." Zhang Bu Yong pointed out It is understood that almost all parents will not agree with children as subjects of clinical trials of drugs Due to the lack of clinical trial data of children's drugs, there are no clear instructions for children's usage and dosage in many drug manuals The words "children's dosage should be reduced", "children's medication should follow the doctor's advice", "children's test has not been carried out and there is no reliable reference" are very common in the instructions For this reason, the white paper suggests that relevant departments should set up special approval departments for children's drugs to separate the approval of children's drugs and adult drugs, so that the approval process of drugs will be more specific, and at the same time, it is conducive to accelerating the approval of children's drugs The white paper also suggests that the national catalogue of essential drugs for children, the management and specification of children's clinical medication, the regulations on the management of drug instructions and labels should be promulgated as soon as possible, and the detailed policies and rules on bidding, pricing and medical insurance for children's drugs should be formulated at the same time Finally, in the case of perfect rules and regulations, "children's health law" was issued