Encourage the R&D and production of children's medications through multiple measures-to meet medication needs and ensure medication safety

The seventh national census showed that the population of 0-14 years old in China is 253.
38 million, accounting for 17.
95% of the total population, an increase of 1.
35 percentage points from 2010
.

With the implementation of the three-child policy, the number of children in our country will continue to increase

Children are in the growth and development stage, the immune system is not yet perfect, and the prevalence, medical treatment, and medication rates are higher than those of adults
.

In recent years, China has attached great importance to ensuring the supply of medicines for children, and has adopted a series of measures to encourage the development and production of medicines for children, alleviate the shortage of medicines for children, and ensure the safety of medicines for children

Open the green channel for review and approval

Adhere to child-centered and clinical needs-oriented, high standards, strict requirements, and strong services to ensure that the quality of drugs after the market is guaranteed

Not long ago, entecavir granules for children developed by a pharmaceutical company in Hunan were approved for marketing, and children with hepatitis B have special drugs
.

"Take medicine by breaking, and dosage by guessing
.

" In the past, many parents of children with hepatitis B often encountered such pain points

The rapid approval of entecavir granules for marketing benefited from the green channel for review and approval opened by the State Food and Drug Administration
.

In August 2019, the newly revised Drug Administration Law clearly stipulates that the state shall take effective measures to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children, and give priority to the review of children's drugs Approval

"Compared to adults, children have higher requirements for drug safety
.

Children's drug use requires close cooperation in professional review, business management, technical support, inspection and verification, etc.

In February of this year, the State Food and Drug Administration organized a children’s drug review team to investigate and investigate the Beijing Children’s Hospital affiliated to the Capital Medical University of the National Children’s Medical Center to communicate with clinicians and clinical pharmacists to understand the technology in the development, use and review of children’s drugs Problem
.

In May, I went to Shandong Dyne Marine Biopharmaceutical Co.
, Ltd.

“Doing a good job in pre-review and approval services can also improve the efficiency of review and approval
.

” According to Yang Zhimin, Director of the Department of Clinical Medicine, Department of Drug Appraisal, National Food and Drug Administration, the Center’s official website has opened a column for children’s medications, and provides relevant policies, regulations and guidance on children’s medications.

The improvement of the efficiency of review and approval has accelerated the launch of children's medicines
.

According to data released by the State Food and Drug Administration, in 2020, a total of 26 special medicines for children and increased use of medicines for children were approved, a year-on-year increase of 36.

Increase R&D productivity

Pediatric medical institutions should put forward their needs, actively strengthen cooperation with scientific research institutions and enterprises, and form a "production, study, research and application" children’s drug R&D and production system

In May of this year, the midazolam oral solution developed by a pharmaceutical company in Yichang City, Hubei Province was approved by the State Food and Drug Administration, filling the gap in the domestic midazolam oral solution and bringing good news to children
.
The company took two years to develop the midazolam oral solution and cost nearly 15 million yuan
.

Midazolam is a sedative and hypnotic.
It is mainly used for sedation before anesthesia, auxiliary local anesthesia, gastroscopy and other sedation before endoscopic surgery
.
It has a wide range of clinical applications .
Previously, all medical institutions in China used midazolam for injection
.
Before the operation, many children refused the injection because of fear, and even cried, which affected the progress of the operation
.
The oral solution of midazolam is added with a flavoring agent, which tastes good, and the children are willing to take it, which has the same effect as the injection of midazolam
.

"Children's medicines are still facing problems such as fewer varieties, fewer special formulations and specifications, and insufficient supply
.
" Wang Xiaoling, director of the Department of Pharmacy, Beijing Children's Hospital, said that children are not small-scale adults.
Because their bodies are not yet mature, the liver and kidneys have the ability to metabolize drugs.
The ability to tolerate adverse drug reactions is very low
.
Long-term excessive or improper use of adult drugs can cause irreversible effects on children's bodies
.
In addition, most adult medicines have a bitter taste, and some children are unwilling to take them.
Parents need to find ways to induce them to increase the difficulty of taking medicines
.
Therefore, it is necessary to develop various children's medicines and dosage forms
.

With the strong support of the country, the Beijing Children's Hospital of the National Medical Center took the lead in undertaking the "Thirteenth Five-Year Plan" major new drug creation and technology major special project-"Children's drug varieties and key technology research and development"
.
Unite the research and development forces of 59 scientific research institutes, universities and enterprises across the country, and take clinical needs as the guidance and clinical evaluation as the basis to jointly develop children's medicines
.
Currently, 27 production approval documents/acceptance numbers and 33 clinical approval documents/record numbers/acceptance numbers have been obtained
.
"The research and development of these varieties fills the gap in China's children's drug market and effectively alleviates the shortage of clinical children's drugs
.
" Wang Xiaoling said
.

"Pediatric medical institutions should become the vanguard of children's drug research and development
.
" said Ni Xin, director of the National Children's Medical Center and director of Beijing Children's Hospital.
Medication information
.
Pediatric medical institutions should put forward demands and actively strengthen cooperation with scientific research institutes and enterprises to form a "production, study, research and use" children's drug R&D and production system
.

Dyne Pharmaceuticals is an enterprise specializing in the development and production of children's medicines.
In recent years, there have been dozens of research and development projects
.
As early as 2011, the company established a children's drug research and development center, and carried out in-depth industry-university-research cooperation with the Institute of Materia Medica of the Chinese Academy of Medical Sciences and the School of Pharmacy of Shandong University
.
Yang Jie, chairman of Dyne Pharmaceuticals, said: "The research and development of medicines for children must meet clinical needs, and design and improve product attributes based on children's pathological and psychological characteristics
.
"

"An important reason for the shortage of children's medicine supply is the mismatch between R&D investment and income
.
" Yang Jie said, children's medicine research and development takes a long time, clinical research risks are high, the prescription process is relatively complicated, and the selection of raw materials and excipients and quality control requirements are high.
Lead to high production costs
.
If the price is based on the active ingredients of the drug, the cost of the pharmaceutical company may not be covered, so there is no enthusiasm for production
.
She suggested that the relevant departments should formulate policies to encourage children's drug access and pricing, so that companies have a certain profit margin, so as to encourage companies to invest more manpower and financial resources in the development and production of children's drugs
.

Ensure that medication is safe and effective

Pharmaceutical companies should design dosage forms, packaging and drug delivery devices according to children of different ages, and determine the best ratio of raw materials and excipients to ensure the efficacy of drugs

"At present, the drugs that the hospital can prescribe are mainly shared drugs for adults and children
.
" Wang Xiaoling said, in the Beijing Children's Hospital drug catalog, children-specific drugs accounted for only 5%, adults and children shared drugs accounted for about 59%, and empirical drugs ( There is no information on medication for children in the instructions, and the proportion of medicines used by doctors in children based on clinical experience is about 36%
.
The hospital arranges a pharmacist in each pharmacy to dispense medicines, which eliminates the trouble for parents to dispense medicines by themselves and improves the safety of medication for children to a certain extent
.

"The pharmacist has allocated the medicine in advance, so it is more worry-free to give the medicine to the child!" In the pharmacy of the Beijing Children's Hospital, a parent of a child just got a packet of medicine
.
Most of the pills in the medicine pack have been cut, some are 1/2 of the original pills, and some are only 1/4.

Walking into the backstage of the pharmacy, the reporter saw a pharmacist holding a pill with tweezers in one hand and carefully cutting it with scissors in the other
.
Soon, a red pill was divided into 4 parts
.
The grid on the side table contains the divided pills of various colors
.
These medicines will be automatically packaged through a medicine dispensing machine and distributed to the families of the children
.

However, if the medicine is divided by the hospital, the active ingredients of the medicine may not be evenly divided, and problems such as reduced efficacy and inaccurate dosage may occur
.
In addition, the medicine is exposed to the air during the division process, which increases the risk of contamination
.
how to solve this problem?

"The dose is accurate, and it is convenient and safe for children to take it
.
" Yang Jie believes that to solve the problem of drug distribution from the source, it is necessary to rely on the production of more child-specific dosage forms
.
Pharmaceutical companies should design dosage forms, packaging, and drug delivery devices according to children of different ages to ensure the efficacy and safety of drugs
.

Mercaptopurine is a commonly used medicine for the treatment of leukemia.
It is clinically used as adult tablets.
Each tablet in China has a specification of 50 mg and a diameter of about 1 cm
.
For adult patients, a tablet with a diameter of 1 cm can be swallowed as soon as the neck is raised, but for young children, the tablet is too large and difficult to swallow
.
In addition, mercaptopurine is calculated based on the dosage per kilogram of body weight
.
The single dose for newborns and premature infants is only 1/25 or even 1/50 of the pill.
It is a test of the parents' "drug-breaking" level
.

Leukemia is the number one malignant tumor of children in the country, and it is also one of the most frequently diagnosed diseases in Beijing Children's Hospital
.
In order to solve the problem of medication for children with leukemia, Beijing Children's Hospital has developed mercaptopurine microchip technology, which makes mercaptopurine microchips with a diameter of about 3 mm, the size of which is as small as a rice grain
.
Ni Xin introduced that the mercaptopurine microchip technology can help children accurately administer medications, eliminating the hassle of dispensing medications, making it easier for children to swallow, and improving medication compliance
.

Wang Xiaoling suggested that in order to ensure the accuracy and stability of sub-dose medicines for children, enterprises should standardize, standardize, and homogenize dosages in accordance with technical guidelines
.