Due to the difficulty of children's clinical research, in China, children's drugs have always had the "four less" situation
of few varieties, few dosage forms, few specifications and fewer special drugs.
According to public data, as of May 2022, the number of approved products in China is about 18,400, of which about 930 are children's drugs, accounting for only 5%.
However, in recent years, the problem of children's medication has been receiving increasing national attention
.
In 2016, the Drug Review Center issued the "Announcement on the Basic Principles for the Evaluation of Varieties and the First Batch of Priority Review Varieties for Clinical Urgent Clinical Medication Application for Children's Drug Application", and the first batch of 5 children's drug registration applications were prioritized review and approval
.
The newly revised Drug Administration Law in 2019 encourages the development and innovation of drugs for children, supports the development of new varieties, dosage forms and specifications of drugs for children that meet the physiological characteristics of children, and gives priority to the review and approval
of drugs for children.
The newly revised Measures for the Administration of Drug Registration in 2020 will accelerate the establishment of a priority review channel in the listing registration process, and include children's drugs in the priority review and approval procedure
.
The review time limit for drug marketing authorization applications is generally 200 working days, and the review time limit for the priority review and approval procedure is shortened to 130 working days
compared with the complete declaration path.
In June this year, the State Food and Drug Administration said that it will give priority to the review and approval of children's drugs with clinical value and urgently needed by patients, open a green channel for children's drugs, take the initiative to provide services to research and development enterprises, and take the initiative to provide services in the communication, acceptance, review and other links of enterprises, improve the efficiency of variety processing, minimize the review time, and promote the accelerated review and listing
of children's drugs.
A series of policy support has given major pharmaceutical companies a "strong shot" and stimulated their enthusiasm for
research and development.
It is reported that at present, many pharmaceutical companies are increasing the layout of children's drug research and development, and have begun to usher in results
.
For example, recently, the State Food and Drug Administration issued an announcement to approve the registration and listing of chlorobachan tablets independently developed by Yichang Renfu Pharmaceutical, and simultaneously issued the registration number of chlorbachan's APIs
.
Data show that clobachan tablets are rare disease drugs in children and are suitable for the combination treatment
of seizures in patients with Lennox-Gastaut syndrome (LGS) aged 2 years and older.
At present, Kangzhi Pharmaceutical's Honz-030 has also entered the clinical stage and is scheduled to be declared
in November 2022.
It is reported that the drug is a new type of compound cold medicine without pseudoephedrine ingredients, which is the first imitation in China
.
In addition, Sunflower Pharmaceutical's performance in the field of children's medicine is even more eye-catching
.
In 2021 alone, Sunflower Pharmaceutical acquired 6 varieties of children's drugs in the MAH (Drug Marketing Licensee) model, and the company obtained the domestic agency rights of two children's rare disease drugs hexeic acid oral solution for children such as Powder, Trientine Capsules through the business development model, which is responsible for the import and local sales, marketing and distribution
of drugs in China.
At present, its children's drugs have been very rich, and there are nearly 60 varieties on the market, covering children's respiratory diseases, gastrointestinal system diseases, immune tonic systems, and children's rare disease drug products
.
According to the results of the seventh national census, China's child population is 247 million people, and the corresponding children's drug market is huge
.
In this context, the industry expects that the future prospects of the children's drug market will be very impressive
.
At the same time, in addition to traditional large pharmaceutical companies, more and more domestic cutting-edge small and medium-sized pharmaceutical companies may also begin to pay attention to and invest in the development of children's oncology drugs, contributing more to
the development of children's drugs.