Read in Chinese

Speakers: 

Mr. Li Li, commissioner of the National Medical Products Administration (NMPA)

Mr. Zhao Junning, deputy commissioner of the NMPA

Mr. Huang Guo, deputy commissioner of the NMPA

Mr. Lei Ping, deputy commissioner of the NMPA

Chairperson:

Ms. Xing Huina, deputy director general of the Press Bureau of the State Council Information Office (SCIO) and spokesperson of the SCIO

Date:

Sept. 13, 2024

Xing Huina:

Ladies and gentlemen, good morning. Welcome to this press conference held by the State Council Information Office (SCIO), as part of the series "Promoting High-Quality Development." Today, we have invited Mr. Li Li, commissioner of the National Medical Products Administration (NMPA), to provide a briefing and take your questions. Also present at today's press conference are the NMPA's deputy commissioners Mr. Zhao Junning, Mr. Huang Guo and Mr. Lei Ping.

Now, I'll give the floor to Mr. Li for his briefing.

Li Li:

Ladies and gentlemen, friends from the media, good morning! First, I'd like to extend my heartfelt thanks for your continued attention and support for the work in drug regulation.

Medicines are special commodities that cure diseases and save lives. Ensuring the safety and efficacy of drugs is critical to the health and well-being of the public as well as to economic and social development. General Secretary Xi Jinping has placed great emphasis on this, repeatedly underscoring the need to implement the highest standards, the strictest oversight, the most severe penalties and the most serious accountability. Following these four stringent principles, drug regulatory authorities have worked hard to balance safety with development, efficiency with fairness, and regulation with service. This approach has effectively ensured overall drug safety while driving high-quality development in the pharmaceutical industry. Now, I'd like to give a brief overview of the reforms and progress with drug regulation.

First, we have maintained strict oversight to ensure continuous compliance in drug production and management. Strong regulation fosters a strong industry. We have reinforced dynamic, life-cycle supervision of drugs, centering on three key areas: risk prevention, case investigation and capacity building. Through comprehensive efforts to safeguard and enhance drug safety, we have reinforced the foundation for drug safety in all respects. We have fully supported the national centralized procurement of drugs and medical devices, and ensured 100% coverage in both the inspection of selected manufacturers and the random testing of selected products, guaranteeing that price reductions do not lead to a drop in quality. The evaluation of consistency in quality and efficacy of generic drugs has also made steady progress, with these products now accounting for two-thirds of commonly used chemical drugs in clinical practice. From January to August of this year, 20,696 batches of drugs were inspected nationwide with a compliance rate of 99.43%, reflecting an overall stability in drug safety.

Second, we have deepened reform to support the development and market entry of innovative drugs and medical devices. High-quality development is the foundation for high-level safety. Ensuring public access to safe medicines and improving drug quality rely on the high-quality development of the pharmaceutical industry. To expedite the market entry of innovative drugs and medical devices, we have deepened reform of the review and approval process. This reform is characterized by early involvement, tailored policies for individual companies and a collaborative approach between research and review. Since the establishment of the NMPA in 2018, we have issued 357 technical review guidelines for drugs and 494 for medical devices — more than the total over previous decades — providing strong support for pharmaceutical R&D and technical evaluations. In recent years, China's pharmaceutical innovations have shown remarkable momentum, with new product launches picking up the pace. From January to August of this year, the NMPA approved 31 innovative drugs and 46 innovative medical devices, representing year-on-year increases of 19.23% and 12.16%, respectively. Innovative drugs concerning small-molecule targeted therapies, immunotherapies and cell therapies have made significant progress when entering global markets, with international recognition for Chinese innovative drugs increasing. High-end medical devices, including surgical robots, artificial hearts and carbon ion therapy systems, have also been launched, with some products achieving global leadership.

Third, we have upheld the rule of law by improving the legal and regulatory framework for drug management. The rule of law is the strongest defense for drug safety and ensures the best business environment for the pharmaceutical industry. We are fast-tracking improvements to the legal framework for drug regulation, thus adhering to law-based administration and oversight to ensure that all regulatory work operates within a sound legal structure. In recent years, we have formulated and revised the Drug Administration Law, the Vaccine Administration Law, the Regulations for the Supervision and Administration of Medical Devices and the Regulations on Supervision and Administration of Cosmetics, along with 14 core rules supporting these two laws and two regulations, thus creating an upgraded legal framework for drug regulation in the new era.

Fourth, we have upheld the fundamental task of capacity building and achieved concrete progress in modernizing medical product regulation. The supervision of medical products demands specialized technical knowledge, necessitating robust regulatory capabilities as a foundation. Highlighting the fundamental and strategic importance of modernizing medical products regulation, the NMPA has strived to strengthen its foundation, shore up weak links and remove development bottlenecks. The NMPA has highlighted the pivotal role of digitalization in advancing medical product regulation. It has developed and enhanced an information-based system for vaccine and drug traceability. Currently, every vaccine dose in China can be traced from origin to destination, ensuring accountability throughout the process. The NMPA has established a nationwide smart supervision platform for medical products. This platform has digitized the entire registration and application process, allowing all NMPA government services to be accessed online. In addition, the NMPA has earnestly implemented the country's action plan on scientific drug administration. It has made steady progress in establishing key national labs for scientific oversight of medical products and continued developing new tools, standards and measures for medical products supervision. The NMPA has strengthened efforts to train personnel for medical product regulatory authorities. It has adjusted plans to establish national inspection centers for vaccines and special medical products. Four subcenters for review and inspection have been set up in the Yangtze River Delta and the Guangdong-Hong Kong-Macao Greater Bay Area. Finally, the NMPA has cultivated skilled professionals for medical product inspection at national and provincial levels, establishing a robust talent pool to support the modernization of medical product oversight.

Moving forward, the NMPA will further enhance its highly effective regulatory measures, maintain stringent safety standards and drive high-quality growth. These initiatives aim to protect and improve public health while advancing China's transition from a major pharmaceutical manufacturer to a global pharmaceutical powerhouse.

That concludes my remarks. My colleagues and I will now be happy to answer your questions. Thank you!