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For a long time, there has been a shortage of medicines for children in China.
Among the more than 6000 pharmaceutical factories in the country, only more than 10 specialize in the production of children's medicines, and only more than 30 enterprises have children's medicine production departments
.
Among the more than 3,500 medicines currently available in China, there are only more than 60 dosage forms exclusively for children
.
In this context, in order to promote the development of the children’s medicine industry, the state has formulated a series of policies in recent years, including strengthening the provision of children’s medicines in hospitals, direct linking to the Internet through bidding and procurement, encouraging research and development, and prioritizing reviews, etc.
, to encourage manufacturers to increase targeted Development and production of medicines for children
.
At present, under the influence of good news, more and more children's medicines are beginning to emerge
.
Recently, according to the announcement of the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, Cabot Norit Nederland and Hainan Zeshi Pharmaceutical Co.
, Ltd.
jointly declared the 5.
1 type of medicinal charcoal suspension particles to be "children's use in accordance with the physiological characteristics of children.
" "New drug varieties, dosage forms and specifications" are planned to be included in the priority review
.
According to public announcements, this is an antidote that can be used for acute poisoning or overdose by oral administration
.
The industry believes that if the medicinal charcoal suspension particles declared this time are successfully approved, it will bring new treatment options to more children
.
In fact, under the influence of policies, the development and review of children's medicines in 2021 has shown a significant increase in momentum
.
In addition to the 5.
1 category medicinal charcoal suspension particles being included in the priority review, on August 3, Luoxin Pharmaceutical also announced that its subsidiary Shandong Yuxin recently received approval from the National Food and Drug Administration (NMPA) "Drug Registration Certificate" issued for ambroxol hydrochloride spray
.
This product is a 2.
4-type new medicine, which is a special medicine for children.
It is suitable for thick sputum and difficult sputum excretion in children aged 2-6.
It will bring new treatment options for children's respiratory diseases
.
According to incomplete statistics, more than 10 children's medicines have been approved for marketing since 2021
.
Among them, some medicines also provide better dosage forms, such as vigabatrin powder for the treatment of infantile spasms, and nitisinone capsules for the treatment of type 1 tyrosinemia, etc.
.
In addition, there are currently more than 40 new pediatric drugs in the country that are at the stage of clinical approval and above
.
In terms of dosage forms, new drugs under development are mainly granules, oral liquids, and sprays
.
The analysis believes that, on the whole, China's children's medicine market has ushered in new development opportunities
.
In the future, under the policy-guided research and development of children's drugs and the liberalization of the "three-child policy", the industry predicts that the market size of children's drugs will continue to maintain an average annual growth rate of more than double digits for a long time
.
At the same time, with the successive approval of new drugs, it will also bring more and better choices for children's medication
.
However, it is worth noting that the lack of children’s clinical trials has led to still very difficult research and development.
The high ethical requirements of children’s drug clinical trials need to take into account the characteristics and affordability of the children population, and the difficulty of recruiting research subjects.
There is still a long way to go to develop children's medicines.
In addition to accelerating innovation, it is also necessary to maintain good communication with drug review departments and medical institutions to jointly accelerate the development of children's medicines
.
Among the more than 6000 pharmaceutical factories in the country, only more than 10 specialize in the production of children's medicines, and only more than 30 enterprises have children's medicine production departments
.
Among the more than 3,500 medicines currently available in China, there are only more than 60 dosage forms exclusively for children
.
In this context, in order to promote the development of the children’s medicine industry, the state has formulated a series of policies in recent years, including strengthening the provision of children’s medicines in hospitals, direct linking to the Internet through bidding and procurement, encouraging research and development, and prioritizing reviews, etc.
, to encourage manufacturers to increase targeted Development and production of medicines for children
.
At present, under the influence of good news, more and more children's medicines are beginning to emerge
.
Recently, according to the announcement of the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China, Cabot Norit Nederland and Hainan Zeshi Pharmaceutical Co.
, Ltd.
jointly declared the 5.
1 type of medicinal charcoal suspension particles to be "children's use in accordance with the physiological characteristics of children.
" "New drug varieties, dosage forms and specifications" are planned to be included in the priority review
.
According to public announcements, this is an antidote that can be used for acute poisoning or overdose by oral administration
.
The industry believes that if the medicinal charcoal suspension particles declared this time are successfully approved, it will bring new treatment options to more children
.
In fact, under the influence of policies, the development and review of children's medicines in 2021 has shown a significant increase in momentum
.
In addition to the 5.
1 category medicinal charcoal suspension particles being included in the priority review, on August 3, Luoxin Pharmaceutical also announced that its subsidiary Shandong Yuxin recently received approval from the National Food and Drug Administration (NMPA) "Drug Registration Certificate" issued for ambroxol hydrochloride spray
.
This product is a 2.
4-type new medicine, which is a special medicine for children.
It is suitable for thick sputum and difficult sputum excretion in children aged 2-6.
It will bring new treatment options for children's respiratory diseases
.
According to incomplete statistics, more than 10 children's medicines have been approved for marketing since 2021
.
Among them, some medicines also provide better dosage forms, such as vigabatrin powder for the treatment of infantile spasms, and nitisinone capsules for the treatment of type 1 tyrosinemia, etc.
.
In addition, there are currently more than 40 new pediatric drugs in the country that are at the stage of clinical approval and above
.
In terms of dosage forms, new drugs under development are mainly granules, oral liquids, and sprays
.
The analysis believes that, on the whole, China's children's medicine market has ushered in new development opportunities
.
In the future, under the policy-guided research and development of children's drugs and the liberalization of the "three-child policy", the industry predicts that the market size of children's drugs will continue to maintain an average annual growth rate of more than double digits for a long time
.
At the same time, with the successive approval of new drugs, it will also bring more and better choices for children's medication
.
However, it is worth noting that the lack of children’s clinical trials has led to still very difficult research and development.
The high ethical requirements of children’s drug clinical trials need to take into account the characteristics and affordability of the children population, and the difficulty of recruiting research subjects.
There is still a long way to go to develop children's medicines.
In addition to accelerating innovation, it is also necessary to maintain good communication with drug review departments and medical institutions to jointly accelerate the development of children's medicines
.
