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In principle, the National Essential Medicines List is adjusted every three years
.
However, in Article 12 of the 2021 edition, the adjustment of the essential medicines list has been accelerated: "The national essential medicines list adheres to regular assessment and dynamic management, and the adjustment period shall not exceed 3 years in principle
.
" Today, the 2018 essential medicines list is closer.
Three years have passed since the adjustment, which means that the three-year period has come, and a new round of essential drug list adjustment is imminent
.
In the 2018 essential drug list adjustment, a total of 685 varieties were shortlisted, so which varieties will be included in the upcoming essential drug list adjustment? It is understood that China's basic drug transfer standards are mainly based on the order of the disease spectrum, incidence rate, disease burden, etc.
, to meet the basic drug needs of common diseases, chronic diseases, diseases with heavy burden, serious harm, critical illness, public health, etc.
Select an appropriate number of essential medicines from the medicines already on the market in China; at the same time, support traditional Chinese medicines and innovative medicines
.
According to the "Administrative Measures for the National Essential Medicines List (Revised Draft)" (hereinafter referred to as the "Draft") released in November 2021 for public comments, the national essential medicines include the list of chemical drugs and biological products, the list of traditional Chinese medicines, and the list of children's medicines
.
Among them, chemical drugs and biological products are mainly classified according to clinical pharmacology, Chinese patent medicines are mainly classified according to function, and children's drugs are mainly classified according to children's special medicines
.
Compared with the 2015 edition of the Essential Medicines List, children's medicines are the focus of this adjustment
.
China's children's drug market has a long-standing current situation of few special varieties, few suitable dosage forms, and few production enterprises, which are mainly related to factors such as the high difficulty of research and development of children's drugs, large investment, and low profits
.
According to the data, among the more than 3,500 varieties of pharmaceutical preparations currently available in China, there are only more than 60 varieties of special drugs for children, accounting for only 1.
7%
.
In order to alleviate the bottleneck of children's drug shortage and ensure the safety of children's drug use, in recent years, relevant departments in my country have successively issued a series of policy measures to encourage and support the research and development of children's drugs, and open green channels to give qualified children's drugs priority review and other qualifications.
Strengthen hospital equipment, direct online bidding for procurement, simplify procurement procedures, expand the scope of medical insurance payment, and ensure demand, etc.
.
For example, on March 30, 2020, the State Municipal Bureau of Supervision issued the newly revised "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production", which included the urgently needed children's drugs in the scope of accelerated marketing registration; in August 2020, the state The Center for Drug Evaluation of the Food and Drug Administration issued the "Technical Guiding Principles for Real-World Research Supporting the Development and Review of Children's Drugs (Trial)", which clarified the common situations and concerns of real-world research supporting the development of children's drugs in China at this stage, and passed the case study.
To explain; in December 2020, the Center for Drug Evaluation issued the "Guidelines for the Development of Pediatric Drugs (Chemical Drugs) Pharmacy Development (Trial)" and "Technical Guidelines for Clinical Pharmacology Research of Pediatric Drugs" to provide R&D ideas and technical guidance for the pharmaceutical development of children's drugs , to further clarify the technical requirements for clinical pharmacology research on pediatric drug use
.
The adjustment of essential medicines alone added the classification of children's medicines, and the industry believes that it will lay a foundation for alleviating the current situation of children's medicine shortages
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
However, in Article 12 of the 2021 edition, the adjustment of the essential medicines list has been accelerated: "The national essential medicines list adheres to regular assessment and dynamic management, and the adjustment period shall not exceed 3 years in principle
.
" Today, the 2018 essential medicines list is closer.
Three years have passed since the adjustment, which means that the three-year period has come, and a new round of essential drug list adjustment is imminent
.
In the 2018 essential drug list adjustment, a total of 685 varieties were shortlisted, so which varieties will be included in the upcoming essential drug list adjustment? It is understood that China's basic drug transfer standards are mainly based on the order of the disease spectrum, incidence rate, disease burden, etc.
, to meet the basic drug needs of common diseases, chronic diseases, diseases with heavy burden, serious harm, critical illness, public health, etc.
Select an appropriate number of essential medicines from the medicines already on the market in China; at the same time, support traditional Chinese medicines and innovative medicines
.
According to the "Administrative Measures for the National Essential Medicines List (Revised Draft)" (hereinafter referred to as the "Draft") released in November 2021 for public comments, the national essential medicines include the list of chemical drugs and biological products, the list of traditional Chinese medicines, and the list of children's medicines
.
Among them, chemical drugs and biological products are mainly classified according to clinical pharmacology, Chinese patent medicines are mainly classified according to function, and children's drugs are mainly classified according to children's special medicines
.
Compared with the 2015 edition of the Essential Medicines List, children's medicines are the focus of this adjustment
.
China's children's drug market has a long-standing current situation of few special varieties, few suitable dosage forms, and few production enterprises, which are mainly related to factors such as the high difficulty of research and development of children's drugs, large investment, and low profits
.
According to the data, among the more than 3,500 varieties of pharmaceutical preparations currently available in China, there are only more than 60 varieties of special drugs for children, accounting for only 1.
7%
.
In order to alleviate the bottleneck of children's drug shortage and ensure the safety of children's drug use, in recent years, relevant departments in my country have successively issued a series of policy measures to encourage and support the research and development of children's drugs, and open green channels to give qualified children's drugs priority review and other qualifications.
Strengthen hospital equipment, direct online bidding for procurement, simplify procurement procedures, expand the scope of medical insurance payment, and ensure demand, etc.
.
For example, on March 30, 2020, the State Municipal Bureau of Supervision issued the newly revised "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production", which included the urgently needed children's drugs in the scope of accelerated marketing registration; in August 2020, the state The Center for Drug Evaluation of the Food and Drug Administration issued the "Technical Guiding Principles for Real-World Research Supporting the Development and Review of Children's Drugs (Trial)", which clarified the common situations and concerns of real-world research supporting the development of children's drugs in China at this stage, and passed the case study.
To explain; in December 2020, the Center for Drug Evaluation issued the "Guidelines for the Development of Pediatric Drugs (Chemical Drugs) Pharmacy Development (Trial)" and "Technical Guidelines for Clinical Pharmacology Research of Pediatric Drugs" to provide R&D ideas and technical guidance for the pharmaceutical development of children's drugs , to further clarify the technical requirements for clinical pharmacology research on pediatric drug use
.
The adjustment of essential medicines alone added the classification of children's medicines, and the industry believes that it will lay a foundation for alleviating the current situation of children's medicine shortages
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
