Many children's drug registration certificates have been cancelled!

According to data, there are currently about 253 million children aged 0-14 in China, accounting for 17.
95% of the total population
.
With the liberalization of childbirth policies such as "second child" and "three child", the proportion of the child population has rebounded.
The industry predicts that the number of children will continue to increase, and the demand for children's medicine will also increase; by 2021, China's children's medicine will be used.
The market size may exceed 200 billion yuan, and continue to maintain an average annual growth rate of more than double digits
.
However, it is worth noting that compared with the continued growth of the children's drug market, the supply of China's children's drug market is lagging
.
According to data from the National Medical Products Administration (NMPA), among the more than 6,000 domestic pharmaceutical factories, there are more than 30 companies that have a children’s drug production department, and the number of companies that specialize in children’s drugs is even more pitiful, with only more than 10 Among the conventional drugs, there are more than 3,600 prescription drugs for adults, and only more than 60 kinds of drugs for children
.
In addition, under the background of few companies specializing in the production of children's medicines, the research and development products of children's medicines are also very single, and they mainly focus on antibiotics, cold medicines, analgesics and antipyretics
.
In this regard, industry analysts believe that, as a whole, although the market continues to improve, China’s children’s drug market has long-standing children’s drug varieties, ambiguous doses, and lack of specifications, which are also restricting the domestic children’s drug industry and related issues.
The healthy development of pharmaceutical companies
.
In fact, apart from China, the lack of medicine for children has always been a worldwide problem
.
However, in recent years, as the drug administration departments around the world have successively formulated relevant measures to promote the research and development and supervision of children's drugs, more and more new breakthroughs like Livmarli are emerging in this field
.
For example, in China, in recent years, as the issue of children's medication has become a livelihood issue that the country attaches great importance to, in order to increase the research and development enthusiasm of manufacturers, the State Food and Drug Administration, the National Health Commission, and the Medical Insurance Bureau have successively introduced a series of policy measures.
To encourage the development, production and sales of children’s drugs
.
For example, in April and May of this year, the Center for Drug Evaluation successively discussed the "Technical Guidelines for Clinical Trials of Modified New Drugs for Children's Chemical Drugs (Draft for Solicitation of Comments)" and "Technology for writing related information about children's drugs in the instructions for chemical drugs and therapeutic biological products.
" Guiding Principles (Draft for Solicitation of Comments)" The two guiding principles are open for public comment, and further strengthen the technical guidance of children's medication
.
In September, after the State Food and Drug Administration issued an announcement requesting the inserts of five anti-tumor drugs on the market to supplement the information on children's medications, the relevant departments issued the "China Children's Development Program (2021-2030)" to encourage the development and production of children's medications and speed up Approval of application for children's medication
.
It also proposed to "explore and formulate a national children's essential medicine list, and timely update the children's banned drugs list"
.
Benefiting from favorable policies and huge market potential, more and more pharmaceutical companies have begun to accelerate and increase their deployment in the children's drug market
.
According to statistics, more than 10 children's medicines have been approved for marketing since 2021
.
In addition, there are currently more than 40 new pediatric drugs in China at the stage of clinical approval and above
.
However, it should be noted that while investing heavily in the development of children's medicines, the industry has also pointed out that relevant companies need to pay more attention to the supervision of drug quality and safety
.
It is reported that the State Drug Administration recently issued an announcement stating that in accordance with Article 83 of the Drug Administration Law and other relevant regulations, it has decided to stop pediatric phenol Aminopyrin Granules, Aminopyrine Tablets, Compound Aminopyrinyl Theophylline Tablets, and other relevant regulations.
The production, sale, and use of 8 varieties of amlinfenol capsules, aminocamin tablets, bufenac cream, children's compound aspirin tablets, and amphifenac tablets in China have been cancelled for drug registration certificates
.
After sorting out, industry insiders found that the 8 types of drugs cancelled this time involved a total of 64 approval document numbers
.
Among them, Xiaoerfenaminokamin granules involve many pharmaceutical companies, including 37 relevant approval document numbers
.