CCTV News: The State Food and Drug Administration released the "2024 Annual Drug Review Report" today (March 18). The report shows that in 2024, my country approved 48 Class 1 innovative drugs throughout the year, covering nearly 20 treatment areas such as tumors, neurological diseases, endocrine system diseases and anti-infection. A large number of new and good drugs are accelerating their benefits to patients.

Yuan Lijia from the Business Administration of the Drug Review Center of the State Food and Drug Administration said that in response to urgently needed drugs in clinical practice, the State Food and Drug Administration has established multiple channels for accelerated drug market launch. Taking the priority review and approval procedure as an example, the regular 200 working day review time limit is shortened to 130 working days to complete the review. In 2024, the State Food and Drug Administration included 124 applications for priority review and registration involving 88 varieties, an increase of more than 14% year-on-year. In 2024, the State Food and Drug Administration completed the priority review and approval procedures and completed 110 drug registration applications, involving 74 varieties, an increase of more than 29% year-on-year.

Since the implementation of the "Drug Registration Management Measures" in 2020, a total of 496 drug registration applications have been included in the priority review and approval procedures, including anti-tumor drugs, dermatological and enthalpy drugs, endocrine system drugs, etc., among which anti-tumor drugs account for the largest proportion, at 42.54%.

The report shows that in 2024, the State Food and Drug Administration accelerates the approval and launch of drugs such as innovative drugs, rare disease drugs and children's drugs: 48 varieties of Class 1 innovative drugs were approved, of which 17 varieties were approved for marketing through the priority review and approval procedures; 11 varieties were approved for marketing with conditions, and 13 varieties were included in the breakthrough therapeutic drug procedures during clinical trials.

Approved 55 varieties of rare diseases (not including 4 generic drugs for chemical drugs), of which 20 varieties were accelerated through the priority review and approval procedures, and 2 varieties were approved for marketing with conditions;

Approved 106 varieties of children's medication, including 71 marketing authorization applications, of which 20 varieties were accelerated through the priority review and approval procedures; 35 varieties were approved to expand the indications of children, greatly alleviating the selection of pediatric medications.

In addition to the enhanced medical protection for children, the accessibility of shortage drugs has also been significantly improved. In 2024, the State Food and Drug Administration approved 117 shortages of drugs (21 varieties), and a total of 226 approved in the past five years, covering 12 areas such as circulation and nerves.

In terms of breakthrough therapeutic drug procedures, the State Food and Drug Administration received a total of 337 applications in 2024 and agreed to include 91 (84 indications), an increase of 30% year-on-year. Since the implementation of the "Drug Registration Management Measures" in 2020, a total of 294 breakthrough therapeutic drug procedures (246 indications) have been included, and the top three are anti-tumor drugs, neurological disease drugs and anti-infective drugs.

Drug review hits a new high, and anti-tumor drug research and development leads

In 2024, the efficiency and quality of drug review in my country have been significantly improved. The State Food and Drug Administration reviewed 18,259 applications for registration of various drugs throughout the year, an increase of 16.2% year-on-year, setting a record high. my country's innovative drug research and development vitality is emerging, and anti-tumor drugs lead chemical drugs and biological products. According to reports, the review volume hits a new high, which is a powerful witness to the rapid development of my country's biopharmaceutical industry. The high-quality new and good drugs have been approved for marketing, which not only provides more and better clinical drug choices for Chinese patients, but also marks that my country has firmly established a foothold in the global medical landscape and provides more Chinese solutions to patients around the world.

In 2024, the application for clinical trials and licenses for anti-tumor new drugs ranked first among chemical drugs and biological products, and even occupied half of the market.

Geng Ying, deputy director of the Clinical Department of the Drug Review Center of the State Food and Drug Administration, said that among the clinical trial applications approved in 2024, anti-tumor drugs account for the highest proportion, with chemical drugs reaching more than 41% and biological products reaching more than 55%. Throughout 2024, the number of innovative drugs approved for marketing was the highest, with chemical drugs and biological products reaching more than 36%.

The reporter noticed that the research and development of traditional Chinese medicine modernization has accelerated. In 2024, applications for clinical trials of traditional Chinese medicine increased by 33.33% year-on-year. At the same time, in order to allow Chinese patients to enjoy the latest achievements of global drug innovation and development, the State Food and Drug Administration approved 89 varieties of drugs that have been marketed overseas and not marketed in China throughout the year, of which 64 were first approved for marketing and 25 were added to the indications of drugs that have been marketed.

The standards are consistent and mutually recognized. New drug reviews are in line with Europe, the United States and Japan. In 2024, the State Food and Drug Administration was successfully re-elected as a new ICH, which is a member of the Management Committee of the International Technical Coordination Association for Human Use Drug Registration. At present, my country has fully implemented 71 ICH guiding principles, which means that China's drug review standards are in line with international regulatory agencies such as Europe, America, Japan, and achieve international alignment.

The State Food and Drug Administration issued 73 technical guidelines for drug research and development throughout the year 2024, involving radioactive drugs, cell and gene therapy products, traditional Chinese medicine, rare disease drugs, children's drugs and other products. As of the end of 2024, my country has issued a total of 555 drug technical guidelines.

Xu Zhenyu, director of the Business Management Office of the Drug Review Center of the State Food and Drug Administration, said that China's review system is promoting the high-quality development of the pharmaceutical industry with the core principles of innovation-driven, international integration, and people's livelihood priority. In the future, with the continuous innovation of regulatory science, China's new drugs will provide more "Chinese solutions" for patients around the world.