-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
【Pharmaceutical Industry News】 In recent years, with the strong support of the state, the development of children's medicine has shown a steady tre.
According to statistics, among the new drugs approved in China in the first half of 2022, a total of 12 drugs can be used for the treatment of children's diseases, involving different fields of children's diseas.
Among the 12 new drugs approved in the first half of 2022, 7 are new dosage forms/specifications; they are mainly developed for children with poor compliance and differences in dosage from adul.
In addition, according to data released by the State Food and Drug Administration, in 2020, a total of 26 special medicines for children and more medicines for children were approv.
In 2021, it will reach 47, a year-on-year increase of 877%; 14 of them will be included in the priority revi.
Pediatric use refers to a class of drugs intended for use in children under the age of 1In recent years, the state has paid more and more attention to the research and development of children's medicines, and has continuously issued policies to support the development of children's medicin.
It is reported that on June 1, the State Food and Drug Administration released the 2021 annual drug review report, which mentioned 41 children's drug u.
The report shows that in 2021, a total of 115 registration applications (69 varieties) will be included in the priority review and approval process, of which 34 new varieties, dosage forms and specifications of children's medicines meet the physiological characteristics of children, accounting for 25
The priority review resources of the Center for Drug Evaluation are increasing year by year to the registration applications of new drugs with clinical advantages, children's drugs, and drugs for rare diseas.
In addition, by the end of 2021, a total of 12 children's medicines have been released in China, including the "Guidelines for Pharmacy Development of Children's Drugs (Chemicals) (Trial)" and "Technical Guidelines for Real-World Research to Support the Development and Review of Children's Drugs (Trial)" Specific guidelines to guide the development of medicines for childr.
In May of this year, the draft revision of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" was released to the public for commen.
Article 28 stated that the state encourages the development and innovation of children's medicines; priority should be given to children's medicin.
Review and approval; for the first new varieties, dosage forms and specifications for children approved for marketing, and for children with increased indications or usage and dosage, a market exclusivity period of up to 12 months will be given, during which the same varieties will not be approved for marketi.
Applicants are encouraged to submit research and development plans for children's dosage forms, strengths, and dosage when submitting a drug marketing authorization applicati.
Encouraged by a series of favorable policies, domestic pharmaceutical companies are also eager to develop children's medicin.
For example, Sunflower Pharmaceutical recently announced that it plans to invest 54 million yuan to invest in the establishment of a wholly-owned subsidiary, Beijing Sunflower Pharmaceutical Research .
, L.
, focusing on overweighting the field of pediatric medici.
Sunflower Pharmaceutical disclosed that the proposed wholly-owned subsidiary will be committed to the introduction of domestic and foreign high-quality children's preparation technology, the research and development of children's generic preparations, and the upgrading of the company's existing varieties and technologies in the field of children's medici.
It is reported that in the field of paediatric medicine layout, the sunflower pharmaceutical industry has made frequent mov.
Among them, only in 2021, it acquired 6 children's drug varieties through the MAH (drug marketing licensee) model, and obtained two rare children's drugs from India's Reddy Pharmaceuticals through the business expansion mod.
Ting capsule domestic agency rights,e.
In addition to Sunflower Pharmaceutical's frequent actions in the field of children's medicine, Jichuan, Dain, Jianmin, e.
, including Hengrui Medicine, Yiling Pharmaceutical and other large pharmaceutical companies are expanding their own drug indications to children's indicatio.
In addition, a New Biotechs have participated in various forms, such as Tianjing Bio, Xianweida Bio, Aike Baifa, Weisheng Pharmaceutical, Baitai Bio, and Beimei Pharmaceutic.
According to the industry, the current China's children's drug market still has problems such as difficult research and development technology, high safety requirements, difficult clinical trials, and small profit margins, causing many companies to stay aw.
However, it is worth noting that in recent years, China has been making continuous efforts to solve the dilemma of "children's medicine depends on breaking, and the dosage depends on guessing", so that domestic research and development technology requirements are in line with international advanced experien.
"I believe that with the promotion of favorable national policies and the efforts of pharmaceutical companies, China's children's drug market will usher in a new development cyc.
" Some industry insiders sa.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
According to statistics, among the new drugs approved in China in the first half of 2022, a total of 12 drugs can be used for the treatment of children's diseases, involving different fields of children's diseas.
Among the 12 new drugs approved in the first half of 2022, 7 are new dosage forms/specifications; they are mainly developed for children with poor compliance and differences in dosage from adul.
In addition, according to data released by the State Food and Drug Administration, in 2020, a total of 26 special medicines for children and more medicines for children were approv.
In 2021, it will reach 47, a year-on-year increase of 877%; 14 of them will be included in the priority revi.
Pediatric use refers to a class of drugs intended for use in children under the age of 1In recent years, the state has paid more and more attention to the research and development of children's medicines, and has continuously issued policies to support the development of children's medicin.
It is reported that on June 1, the State Food and Drug Administration released the 2021 annual drug review report, which mentioned 41 children's drug u.
The report shows that in 2021, a total of 115 registration applications (69 varieties) will be included in the priority review and approval process, of which 34 new varieties, dosage forms and specifications of children's medicines meet the physiological characteristics of children, accounting for 25
The priority review resources of the Center for Drug Evaluation are increasing year by year to the registration applications of new drugs with clinical advantages, children's drugs, and drugs for rare diseas.
In addition, by the end of 2021, a total of 12 children's medicines have been released in China, including the "Guidelines for Pharmacy Development of Children's Drugs (Chemicals) (Trial)" and "Technical Guidelines for Real-World Research to Support the Development and Review of Children's Drugs (Trial)" Specific guidelines to guide the development of medicines for childr.
In May of this year, the draft revision of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" was released to the public for commen.
Article 28 stated that the state encourages the development and innovation of children's medicines; priority should be given to children's medicin.
Review and approval; for the first new varieties, dosage forms and specifications for children approved for marketing, and for children with increased indications or usage and dosage, a market exclusivity period of up to 12 months will be given, during which the same varieties will not be approved for marketi.
Applicants are encouraged to submit research and development plans for children's dosage forms, strengths, and dosage when submitting a drug marketing authorization applicati.
Encouraged by a series of favorable policies, domestic pharmaceutical companies are also eager to develop children's medicin.
For example, Sunflower Pharmaceutical recently announced that it plans to invest 54 million yuan to invest in the establishment of a wholly-owned subsidiary, Beijing Sunflower Pharmaceutical Research .
, L.
, focusing on overweighting the field of pediatric medici.
Sunflower Pharmaceutical disclosed that the proposed wholly-owned subsidiary will be committed to the introduction of domestic and foreign high-quality children's preparation technology, the research and development of children's generic preparations, and the upgrading of the company's existing varieties and technologies in the field of children's medici.
It is reported that in the field of paediatric medicine layout, the sunflower pharmaceutical industry has made frequent mov.
Among them, only in 2021, it acquired 6 children's drug varieties through the MAH (drug marketing licensee) model, and obtained two rare children's drugs from India's Reddy Pharmaceuticals through the business expansion mod.
Ting capsule domestic agency rights,e.
In addition to Sunflower Pharmaceutical's frequent actions in the field of children's medicine, Jichuan, Dain, Jianmin, e.
, including Hengrui Medicine, Yiling Pharmaceutical and other large pharmaceutical companies are expanding their own drug indications to children's indicatio.
In addition, a New Biotechs have participated in various forms, such as Tianjing Bio, Xianweida Bio, Aike Baifa, Weisheng Pharmaceutical, Baitai Bio, and Beimei Pharmaceutic.
According to the industry, the current China's children's drug market still has problems such as difficult research and development technology, high safety requirements, difficult clinical trials, and small profit margins, causing many companies to stay aw.
However, it is worth noting that in recent years, China has been making continuous efforts to solve the dilemma of "children's medicine depends on breaking, and the dosage depends on guessing", so that domestic research and development technology requirements are in line with international advanced experien.
"I believe that with the promotion of favorable national policies and the efforts of pharmaceutical companies, China's children's drug market will usher in a new development cyc.
" Some industry insiders sa.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
