2024-09-25
Recently, at the "Promoting High Quality Development" series of themed press conferences held by the State Council Information Office, Huang Guo, Deputy Director of the National Medical Products Administration, pointed out that in response to the issue of pediatric drugs, the NMPA has issued multiple measures to encourage research and innovation in pediatric drugs, standardize pediatric application information in drug instructions, and strive to meet the clinical medication needs of pediatric patients. The introduction of these measures marks a solid step forward in China's efforts to ensure the protection of children's drugs.
The importance of strengthening the research and production of children's medication
Children are the future and hope of a country, and their healthy is related to the happiness of millions of families. However, due to the differences in physiological characteristics and drug metabolism processes between children and adults, the safety and effectiveness of pediatric drugs have always been of great concern to society. For a long time, the pediatric drugs market has faced problems such as a single variety, insufficient supply, and inappropriate dosage, which poses potential risks to children's health. Therefore, strengthening the research and production of pediatric drugs is of great significance for ensuring the safety, effectiveness, and convenience of pediatric drugs.
Measures and Actions of the NMPA
In order to solve the problem of medication for children, the NMPA has taken a series of measures.
Firstly, the NMPA implements a priority review and approval policy to accelerate the speed of marketing pediatric drugs. We have collaborated with relevant departments to develop lists of pediatric drugs that encourage research and application, and have achieved good results in the past three years. In 2021, the number of approved pediatric drugs was 47, which increased to 66 in 2022 and further to 92 in 2023. From January to August this year, 49 approvals have been completed, indicating a rapid growth trend in the development of new pediatric drugs.
Secondly, the NMPA has improved drug instructions and added information on pediatric drugs. The NMPA has released the "Work Procedure for Adding Children's Medication Information to Listed Drug Instructions (Trial)". In response to the urgent need for pediatric clinical drugs, enterprises will strengthen scientific research, regulatory departments will organize rigorous evaluations, and add children's application information to the instructions to better ensure the safety and effectiveness of children's clinical medication.
Deputy Director Huang Guo introduced that as of now, the NMPA has issued three batches of revised announcements for 15 varieties and 49 product specifications. New types of medication information for children have been added, involving anti-tumor drugs for children, such as childhood leukemia, medication for severe mental disorders in children, including serious illnesses such as autism, depression, and schizophrenia.
Strengthen international cooperation and exchanges
In addition, the NMPA is accelerating the improvement of research and development technology requirements and aligning with international standards. 21 standards and guidelines for the development of pediatric drugs have been released, which is comparable to regulatory agencies in developed countries. Among them, the "Technical Guidelines for Real World Research to Support the Development and Evaluation of Pediatric Drugs" and the "Technical Guidelines for the Design and Evaluation of Pediatric Drug Taste" are global firsts and leading in the global regulatory field, contributing Chinese wisdom and solutions to the global cause of children's health.
At the same time, in order to better meet the global demand for pediatric drugs, the NMPA actively strengthens cooperation and exchanges with international peers in the research and production of children's medication. Accelerate the research and development of pediatric drugs in China by introducing advanced technology and experience from abroad.
In short, the NMPA has taken further measures to increase the research and production of pediatric drugs, providing strong guarantees for safeguarding children's health. At the same time, pharmaceutical companies should also increase investment, continuously innovate research and development, provide more safe and effective drugs for children, and safeguard their healthy growth.
About Beimei Pharma
Shenzhen Beimei Pharmaceutical Co., Ltd. ("Beimei Pharma") focuses on the field of pediatric prescription medicines, integrating full-spectrum capabilities of R&D, manufacture, commercialization and global cooperation, driven by the core strategy of self-development and global collaboration via in-licensing, asset purchase acquisition etc. Synergizing with the manufacture base in Liangyungang to fulfil sufficient production and global supply of diversified special formulations for children's medications, Beimei is aiming to provide pediatric patients with high-quality and full range of drugs.
Beimei Pharma has more than 40 pediatric drug products in portfolio and pipeline, including 4 approved drugs launched in the market, and several innovative drugs with global rights and independent intellectual property rights. The current pipeline covers the therapeutic fields of dermatology, respiratory, gastroenterology, anti-infection, neurology, neonatal, endocrinology, etc.
Beimei Pharma has established long-term partnerships with multiple large international pharmaceutical companies, such as Hetero, Cipla, Deva, Dr. Reddy’s, LTS, MedPharma, Synthon, EMP, NTC, Syrimed, etc.
Beimei Pharma has completed the Angel Round, Round A, Round B/B+ and Round C financing with hundreds of millions of RMB. Beimei Pharma gained recognition from many well-known investment institutions, including Efung Capital and the industrial parties.
For additional information, please visit the website: http://www.beimeiyaoye.com/
