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!
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Xing Huina:
The floor is now open for questions. Please raise your hand and state the news outlet you represent before asking your questions.
CCTV:
The third plenary session of the 20th Central Committee of the Communist Party of China (CPC) has outlined reforms to boost industries like biomedicine and medical equipment. What specific plans does the NMPA have to implement these reform directives from the CPC Central Committee?
Li Li:
Thank you. I will answer your question. The resolution adopted at the third plenary session of the 20th CPC Central Committee outlines the need to improve the policy and governance systems for promoting the development of strategic industries such as biomedicine. It also stresses efforts to improve the institutions and mechanisms for bolstering key industrial chains such as medical equipment, as well as improve the mechanisms for supporting the development of innovative drugs and medical equipment. Following these guidelines, regulatory authorities for medical products are crafting a wide-ranging policy package to intensify reforms in medical product oversight. Our goals are to create a globally competitive ecosystem for pharmaceutical innovation, expedite innovative drug development, facilitate faster market access for new medical devices, and improve the overall quality and effectiveness of the pharmaceutical industry. These reform initiatives will be wide-ranging, tackling various stages of the process and addressing fundamental challenges. Let me briefly outline a few key areas:
First, the NMPA will bolster support for drug development and innovation. Focusing on key innovative drugs and medical devices that receive national support, the NMPA will enhance its services and guidance in the reviewing, approval, testing and verification process. It will provide guidance for enterprises, ensuring their R&D strategy is driven by clinical value and centered on patient needs. The NMPA will also enhance policy communication and technical counseling concerning product registration and application. It will incorporate the technical expertise of medical product regulatory authorities at both national and provincial levels, establish multi-layered and multifaceted communication methods, and utilize online platforms to host virtual lectures on the review and approval of drugs and medical devices. In addition, the NMPA will work to improve the accessibility of drugs and medical devices. It will implement the CPC Central Committee's decision and arrangements on deepening the coordinated development and governance of health care, medical insurance and pharmaceuticals and proactively support the introduction of innovative drugs and medical devices into hospitals and their inclusion in the medical insurance program.
Second, the NMPA will improve the efficiency of product review and approval processes. The NMPA will speed up the review and approval of urgently needed clinical products, giving priority to certain eligible products. It will reduce the duration of various phases, including technical evaluation and registration-related verification and testing procedures, to expedite the overall approval timeline. It will also reduce the time needed for implied approval of clinical trials, and launch pilot programs in cities like Beijing and Shanghai to cut the review and approval period for innovative drugs' clinical trials from 60 working days to 30. Moreover, the NMPA will optimize the evaluation and approval process for supplementary applications of medical products. It will launch pilot programs in provinces with adequate resources. These programs will offer preliminary services for post-market registration verification and testing changes, aiming to substantially reduce the timeframe for supplementary applications.
Third, the NMPA will support opening up and cooperation in the pharmaceutical sector. The NMPA will enhance the adoption and application of internationally accepted regulatory standards in China. It will also support the initiation of global multi-center clinical trials and promote simultaneous R&D, application, review, and marketing of international medical products in China and worldwide. The NMPA will explore the divided contract production of biological products, and launch pilot programs in select regions for the production of innovative and urgently needed bioproducts. Moreover, the NMPA will bolster support for the import and export of pharmaceuticals, accelerate the administrative approval process of new drugs that have already been introduced to overseas markets, and encourage multinationals to relocate their production line for originator medicines and chemicals, bioproducts and high-end medical devices to China. Furthermore, the NMPA will refine policies concerning export and sales certification for pharmaceuticals. We will encourage more Chinese pharmaceutical companies to participate in global trade, enabling Chinese pharmaceuticals to benefit people all over the world. Thank you!
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Jinan Daily APP:
As we know, traditional Chinese medicine (TCM) is an essential component of our country's conventional pharmacology and a treasure of the Chinese nation. What efforts have medical regulatory departments made to promote the preservation and innovative development of TCM? Thank you.
Li Li:
Thank you for your question. TCM is the material foundation for the inheritance and innovative development of Chinese medicine. The NMPA is continuously improving its regulatory system to align with the unique characteristics of TCM. I will invite Mr. Zhao Junning to answer this question.
Zhao Junning:
I'll answer this question. The NMPA has diligently implemented the policy decisions and plans of the CPC Central Committee and the State Council. We've upheld fundamental principles while breaking new ground, taking multiple steps to promote the preservation and innovative development of TCM.
First, we're improving regulatory frameworks to guide the development of TCM. We are advancing revisions to the Regulations for Implementation of the Drug Administration Law and the Regulations on the Protection of Traditional Chinese Medicines. We have successively issued the Special Provisions for Traditional Chinese Medicines Registration, and the Special Provisions on the Administration of Traditional Chinese Medicine Standards, and are currently studying and formulating special provisions for the supervision and administration of TCM production. Previously, we have published Good Agricultural Practice (GAP) for Chinese Crude Drugs. All of this has actively strengthened our regulatory framework. We have also issued measures for further strengthening the scientific supervision of TCM to promote its inheritance and innovative development, introducing 35 measures in total. These measures follow TCM's unique regulatory characteristics, comprehensively promoting the preservation and innovative development of TCM across the entire chain.
Second, we're reforming the review and approval process to drive the development of TCM. Fully respecting the laws governing the development of Chinese medicine, we have innovatively established an evidence system for TCM registration and review that integrates TCM theories, human use experience, and clinical trials. This "three-in-one" evidence approach allows us to clearly articulate the logic behind TCM's safety, efficacy and quality control, supporting the market launch of new TCM drugs. In recent years, enthusiasm for the research and development of new TCM drugs has surged. The number of clinical trials, market authorization applications, and approvals for new TCM drugs have increased in tandem, all reaching double digits in each of the past two years. In 2023, 10 new TCM drugs were approved for market launch. This year, eight new drugs were launched, offering new options to meet clinical needs.
Third, we're establishing a regulatory system to safeguard the development of TCM. We adhere to a problem-oriented and risk management approach, continuously conducting annual special inspections of TCM production, for-cause inspections, random inspections, exploratory research, and quality monitoring of Chinese medicinal materials. We're deepening efforts to consolidate and improve drug safety, strengthening oversight of online drug sales, and optimizing the distribution and management of Chinese medicinal materials. We're exploring ways to standardize the processing of Chinese medicinal materials at their source and guide the orderly development of Chinese medicinal materials production, improving quality from the outset. The overall passing rate for TCM decoction pieces has risen from 88% in 2018 to around 97% currently. The overall pass rate for TCM drugs has remained stable at over 99% for a long time, effectively ensuring that TCM plays a vital role in clinical practice. The demonstration and promotion of GAP for Chinese crude drugs are showing initial results, effectively stimulating the internal drive of TCM production enterprises.
That's all for this question. Thank you!
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Cnr.cn:
My question is about medications for rare diseases. We know that in recent years, the issue of medication for patients with rare diseases has attracted widespread attention from society, and I am also very concerned about it. What measures has the NMPA taken to encourage innovation, R&D and introduction of medicines for rare diseases? Thank you.
Huang Guo:
Thank you for your question. Medications for rare diseases indeed require the attention of the entire society. To meet the medication needs of patients with rare diseases, the NMPA has continuously introduced a series of incentive policies and promoted R&D and marketing of medicines for rare diseases through multiple channels. In summary, there are mainly three channels:
First, we're encouraging independent innovation. By promoting the R&D of new medicines in China, we aim to address the lack of available treatments for certain rare diseases. As you may know, we have established accelerated pathways for rare disease drug applications, including breakthrough therapy and medicine designations, conditional approvals, and priority review and approval procedures. Technically, we're enhancing the efficiency of R&D and market launch for rare disease drugs through several methods. These efforts include strengthening communication and guidance during the R&D process, allowing rolling submissions of data, reasonably determining alternative clinical endpoint s, and shortening review timelines. In other words, our goal is speed.
Second, we're expediting the import process to accelerate the entry of rare disease drugs being researched or produced overseas into the Chinese market. On the one hand, we're supporting multinational pharmaceutical companies in conducting simultaneous R&D, application, and market launch in China. To this end, we've implemented a series of measures, such as establishing an implied license system for clinical trials and accepting overseas clinical trial data. On the other hand, we're encouraging the import of rare disease medicines already marketed abroad. Currently, we're soliciting the public's opinions on the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical Settings. For drugs that meet the requirements, we're implementing measures to encourage import applications, including waiving clinical trials, granting priority review and approval, shortening inspection timelines, and reducing the number of inspection batches and samples.
Third, a temporary import channel to try and ensure the availability of urgently needed clinical drugs under special circumstances. In 2022, we collaborated with the National Health Commission to develop and release the Work Plan for the Temporary Import of Urgently Needed Clinical Medications. Over the past two years, this channel has ensured the supply of urgently needed medications like clobazam and sapropterin hydrochloride for rare diseases.
In addition, we have strengthened collaboration with relevant local authorities and departments to create more channels for the clinical use of drugs for rare diseases. Our measures include supporting medical institutions within Hainan's Boao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area with importing urgently needed clinical medications, as well as supporting the establishment of a pilot zone in the Beijing Tianzhu Comprehensive Bonded Zone to ensure the supply of rare disease medications.
Altogether, these measures have led to a significant increase in both the number and speed of rare disease medications entering the market in recent years. Since 2018, over 130 rare disease drugs have been approved for the market, with as many as 37 being approved from January to August 2024.
In the next step, we will continue to make sustained efforts to build and develop these important channels for ensuring the availability of rare disease medications. We will closely collaborate with health, healthcare security and other departments to increase policy support and encourage companies to innovate and conduct research and development, so that more drugs for rare diseases can become available. Thank you!
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Poster News:
I noticed that the resolution adopted at the third plenary session of the 20th Central Committee of the Communist Party of China (CPC) has outlined plans to refine the food and drug safety responsibility system. Which aspects primarily touch upon the drug safety responsibility system? What specific ideas and measures does the medical products administration have in this regard? Thank you.
Li Li:
Thank you for your questions. I will address them. The implementation of responsibilities is the basis and premise for ensuring drug safety. It can be said that the reforms outlined by the third plenary session of the 20th CPC Central Committee regarding the refinement of the drug safety responsibility system capture the key to ensuring drug safety. This system involves a wide range of elements. We need to coordinate the implementation of supervisory responsibilities of government departments, the primary responsibilities of companies and the jurisdictional responsibilities of local Party committees and local governments, so that responsibilities are shared and efforts are united.
First, the drug regulatory authorities must fulfill their supervisory responsibilities. The supervision of drugs is a duty assigned to the drug regulatory authorities by law, and we are duty-bound. Drug regulatory authorities at all levels must strictly implement supervisory powers and enhance collaboration across regions and levels. The responsibilities and the imperative of fulfilling them must be communicated to specific officials in specific positions. We need to continuously improve the risk consultation mechanism for drug safety and help establish a regular and sustainable approach to identifying, assessing and addressing drug risks within key links, such as clinical trial management, contract drug manufacturing and online drug sales, as well as with key products like vaccines and drugs and medical devices chosen through centralized procurement, and also in key areas, such as rural and suburban areas. In the meantime, we need to strengthen collaboration with public security, health and healthcare security departments to improve systems, such as coordination between administrative law enforcement and criminal justice and joint disciplinary actions, and intensify law enforcement efforts to effectively deter illegal and criminal activities in the field of drug safety.
Second, pharmaceutical companies must fulfill their primary responsibilities. Drug safety depends not only on supervision, but also on production. As those who conduct drug research and development, production, and distribution, pharmaceutical companies hold primary responsibility for drug safety, so they must assume legal obligations for ensuring drug quality and safety. Drug regulatory authorities need to enforce effective supervision, provide more legal and cautionary education to companies, and encourage them to establish robust quality management systems tailored to their specific circumstances and products, so that every participant in the drug production and distribution chain meets their responsibilities, and drug quality and safety are ensured as a result.
Third, local Party committees and local governments must fulfill their jurisdictional responsibilities. General Secretary Xi Jinping has said that "it is a bounden responsibility for Party committees and governments at all levels to ensure drug safety. " According to the requirement for Party committees and governments to share these responsibilities, all localities should make it clear that Party committees and governments take overall responsibility for drug safety within their jurisdictions, with their primary leaders serving as the chief individual responsible for drug safety. Drug regulatory authorities will improve the mechanism for admonition regarding drug safety responsibilities. Localities will be encouraged to integrate drug safety into their economic and social development plans, to regularly assess and analyze their local drug safety conditions, to strengthen technical support capabilities for drug review, inspection, testing, etc., and to support supervisory authorities in fulfilling their legal responsibilities to ensure drug safety for their own regions.
At the same time, we should engage society more effectively in joint efforts for drug safety. Given that drug safety is crucial for people's health and lives, we must supervise drug safety for the people and with their support. We should actively develop teams to assist with supervision through collecting and communicating drug safety information as well as engaging in volunteer activities, and fully leverage the role of professionals, such as pharmaceutical company employees and licensed pharmacists. Through these efforts, we will promote public participation in joint efforts for drug safety. Thank you.
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China News Service:
We noticed that the NMPA publicly solicited opinions in August on the draft Medical Devices Management Law. Could you explain the initial motivation and significance behind the formulation of this specific law? Thank you.
Lei Ping:
Thank you for your question, and for your interest in and support for the NMPA's legal development efforts. In recent years, the NMPA has made rapid progress in its legal framework. We have fully revised the Drug Administration Law, enacted the world's first comprehensive Vaccine Administration Law, and revised the Regulations on the Supervision and Administration of Medical Devices and the Regulations on the Supervision and Administration of Cosmetics, thereby completing the key pillars of China's pharmaceutical regulatory system.
In order to ensure the safety and efficiency of medical devices and to promote high-quality industry development to better meet the public's demand for high-quality medical devices, the 14th NPC Standing Committee has included the Medical Devices Management Law in its legislative plan.
Elevating the management of medical devices from administrative regulations to a law not only raises the legal status, but also enhances the content. There were three main considerations in drafting the Medical Devices Management Law. First, it meets the practical need to promote the high-quality development of the medical devices industry. In recent years, China's medical devices industry has shown strong growth, with a compound annual growth rate exceeding 10% for many years. A specialized law is necessary to elevate the industry to a national strategic level, providing comprehensive and systematic regulations from technology investment, financial support, capacity building, industry standards and academia-industry collaboration, to industry-wide coordination. Second, it is crucial for establishing a comprehensive and systematic regulatory framework. This specialized law will provide a more complete and authoritative legal foundation for governing the medical devices industry. Third, it aligns with the requirements of China's participation in international exchanges and cooperation. A dedicated law will help synchronize with international medical device management laws and better leverage China's role and position in relevant international organizations.
The draft Medical Devices Management Law is currently open for public consultation, and we encourage everyone to offer valuable suggestions to help shape this new law. Together, we can ensure the safety of medical devices for the public. Thank you.
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Jimu News:
The quality of pharmaceuticals is directly related to public health and safety. We noticed that the NMPA is implementing a drug safety consolidation and enhancement campaign. Could you provide an update on its progress and effectiveness? And how does the NMPA plan to further strengthen pharmaceutical quality and safety supervision? Thank you.
Li Li:
Thank you for your interest in the drug safety consolidation and enhancement campaign. I would like to invite Mr. Zhao to provide more details.
Zhao Junning:
I will answer this question. The NMPA places great emphasis on drug safety, consistently working to purify the pharmaceutical market and maintain a stable and improving drug safety landscape. Since June 2023, the NMPA has been implementing a one-and-a-half-year drug safety consolidation and enhancement campaign, aimed at solidifying the foundation of drug safety and protecting public health.
First, we are focused on key issues and are actively resolving risks and hidden dangers. By targeting key products, key processes, key regions and key enterprises, we have conducted special inspections of pharmaceutical operations and uses, special inspections of special medicines, special checks on delegated manufacturing for medical device registrants, supervisory spot checks of clinical trials for medical devices, and special inspections of hair dye cosmetics. We aim to identify and resolve risks and hidden dangers through multiple channels and dimensions, utilizing our capabilities for risk warning, identification and resolution, and taking effective measures to address potential drug safety risks promptly.
Second, we are cracking down on major cases and strictly punishing illegal activities. We are using means such as exposing typical cases and publishing lists of those committing serious violations of law and trust. We ensure that penalties are enforced against individuals responsible for illegal acts, implement joint punishments, ban individuals from the industry, and prohibit certain practices, all in a concerted effort to ensure the stability of drug safety.
Third, we will improve institutional mechanisms and comprehensively enhance regulatory capabilities. We are advancing the implementation of local management responsibilities, strengthening departmental regulatory responsibilities, and reinforcing corporate principal responsibilities to ensure comprehensive drug safety safety. The NMPA, in conjunction with the State Administration for Market Regulation (SAMR), has issued the Guidance on Strengthening Cross-Regional and Multi-Level Drug Regulatory Collaboration, which enhances the coordination among national, provincial, city and county-level drug regulatory departments throughout the entire lifecycle of drugs. In collaboration with the Ministry of Public Security, the NMPA has jointly issued the Guidelines for the Inspection and Determination of Suspected Criminal Cases in the Pharmaceutical Field to promote effective integration of administrative and criminal enforcement efforts. A total of 142 city and county-level drug regulatory departments have been designated as grassroots contact points, achieving a demonstrative and leading effect. Local drug regulatory departments are actively developing teams of township pharmaceutical safety co-managers and rural pharmaceutical safety information officers, extending drug regulatory oversight to townships and rural areas, and enhancing comprehensive governance capabilities at the primary level.
Next, the NMPA will continue to focus on key tasks of the drug safety consolidation and enhancement campaign. We will intensify our efforts, focus on investigating a number of major cases, and strictly punish illegal and non-compliant behaviors. We will also strengthen the investigation and resolution of risks and hidden dangers to solidify the foundation of drug safety. Thank you.
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People's Daily Health App:
In recent years, the NMPA has strongly encouraged the R&D as well as innovation of medical devices. What progress has been made in the review and approval of innovative medical devices? Thank you.
Li Li:
Thank you for your question. Innovative medical devices are a crucial track in the innovation and R&D of pharmaceuticals. I would like to invite Mr. Lei to answer this question.
Lei Ping:
I will answer this question. The NMPA is fully committed to promoting the R&D and innovation of medical devices, rapidly transforming scientific research achievements into innovative products.
We have collaborated by integrating resources and strengthening inter-ministry cooperation. In partnership with the Ministry of Industry and Information Technology (MIIT), we have organized and implemented a leading project system in the field of innovation. We have selected 48 artificial intelligence (AI) projects and 40 high-end medical device projects in the field of biomaterials, providing them with key support during the application process. We have established three innovation cooperation platforms for AI medical devices, biomaterials and high-end medical equipment, bringing together the strengths of industries, universities, research institutes, hospitals and regulatory authorities.
We have advanced regulatory science research, exploring the application of real-world data, evaluation methods for next-generation gene sequencing products, and other new technological areas. This has led to several new tools, standards and methods, which are now being applied in regulatory work.
We have comprehensively innovated the review mechanism, shifting the focus of medical device technical evaluations to the earlier stages of product R&D. This has accelerated the tackling of key core technologies, helping China achieve significant breakthroughs in high-end medical devices. We have established two medical device evaluation and inspection sub-centers in the Yangtze River Delta and the Greater Bay Area. For provinces with large medical device industries, we have set up service mechanisms to ensure that innovative medical device companies can receive timely professional guidance.
We have identified four key areas for support: AI, novel medical biomaterials, high-end medical imaging, and medical robots. We are working to eliminate bottlenecks and challenges hindering the development of these industries.
We regularly organize regulatory consultations to oversee the nation's first-in-class medical devices and those with complex manufacturing processes. We actively guide and urge enterprises to fully uphold their primary responsibility for quality and safety, ensuring the quality and safety of products.
To date, the NMPA has approved 296 innovative medical devices for market entry, primarily in high-end fields such as implantable interventional devices, advanced imaging, and AI-powered medical devices. Some of these products have reached a leading international position. Examples include: third-generation non-contact ventricular assist devices, which provide effective life support for patients with advanced refractory left-sided heart failure awaiting heart transplants; carbon ion therapy system with independent intellectual property rights in China, which offers a more effective treatment option for certain malignant tumors, having successfully treated over 1,400 patients; advanced deep brain stimulation devices, which have been clinically applied in over 480 hospitals, implanted in 27,000 patients and reached clinical application in eight countries; and innovative PET-CT products, which can image the entire human body with a single scan, offering high resolution scans at low radiation doses. These innovative medical devices not only fill domestic gaps but also significantly reduce the costs of diagnosis and treatment, directly benefiting the public.
Going forward, the NMPA will continue to adhere to a people-centered approach, constantly summarizing experiences and optimizing procedures to launch more high-quality, high-end innovative medical devices. This will ensure that the public truly feels the tangible benefits. Thank you.
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21st Century Business Herald：
As regulatory capabilities continue to improve, the informatization level at the NMPA has also seen continuous enhancements. Could you briefly introduce the NMPA's approach, initiatives and achievements in intelligent supervision? Thank you.
Li Li:
Thank you for your question. Informatization serves as a multiplier of drug regulatory effectiveness and is the driving force behind the modernization of drug regulation. For more specific details on this matter, I'll defer to Deputy Director Mr. Huang for his response.
Huang Guo:
The NMPA places great importance on the development of information technology. It has explicitly stated its intention to use information technology as a guiding force for the modernization of drug regulation and has continuously implemented a smart regulation action plan to enhance supervision through new standards, technologies and tools. At the same time, we hope to leverage regulatory informatization to drive the digital transformation and upgrading of the pharmaceutical industry.
Let me provide a few examples. For instance, we have focused on facilitating businesses and the public by both optimizing and upgrading government services. Given the highly technical and complex nature of drug evaluation and approval, we have developed and improved an integrated system for the registration, filing and approval of drugs, medical devices and cosmetics. This system meets the requirements to efficiently complete a task, enabling full integration and coordination of the entire process from acceptance and evaluation to approval and certification.
As Director Li Li mentioned earlier, the NMPA has now realized 100% online processing for administrative services. Furthermore, all business-related licenses at the bureau level are fully digitalized, with over 170,000 electronic certificates issued to date. Businesses now only need to visit a unified online platform or a single service portal to handle all of their affairs.
For instance, we focus on risk prevention and control by continuously strengthening the supervision of drugs circulation. We are enhancing the use of big data in drug regulation, advancing production line coding and full-process traceability for key products. We have also started phasing in a unique identification system for medical devices, establishing a unique identification database and promoting a "one code manages the entire process" approach. Additionally, in light of the rapid growth of online sales of drugs, medical devices and cosmetics, we are continuously developing an online sales monitoring platform, using an "internet-based management" approach to strengthen problem detection and resolution.
Here is a set of data: currently, over 27,000 websites are under routine monitoring, with an average of more than 10 million product pages monitored each month. A cross-level collaborative mechanism has been established for network monitoring, risk warning, risk identification, verification and resolution as well as risk elimination. This mechanism effectively and continuously works to purify the online sales environment.
Additionally, we have focused on the industry development scenario by steadily advancing the digital regulation of drug production. While continuously innovating smart regulation methods and approaches, we strive to promote and integrate smart regulation with intelligent manufacturing in China's pharmaceutical industry. For key products such as vaccines, blood products and special drugs, we have developed digital technology guidelines for production and inspection to support the digital transformation and upgrading of relevant manufacturing enterprises.
Currently, all vaccine manufacturers in China have implemented electronic recordkeeping and management for production and inspection data, significantly enhancing the level of quality and safety assurance. This year, the NMPA revised the appendix on blood products in the Good Manufacturing Practice for Drugs. Additionally, the Three-Year Action Plan for Intelligent Supervision of Blood Product Production and the Technical Guidelines for Electronic Records of Blood Product Production Inspection have been introduced to address challenges in the quality management of blood products through informatization, promoting the overall transformation and upgrading of blood product production.
Going forward, we will continue to accelerate the development of smart regulation, with a focus on the development and application of new technologies such as artificial intelligence. We will leverage digitalization and smart technologies to enhance the efficient governance of drug safety.
That concludes my explanation. Thank you!
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Xing Huina:
Next question, please. I notice two journalists both have their hands raised.
Red Star News：
In recent years, the cosmetics market has experienced rapid growth, and the use of cosmetics has become part of people's everyday life. Could you please share what measures the NMPA has taken to regulate the development of the cosmetics industry? What are the future plans and considerations in this regard? Thank you.
Li Li:
Thank you for your questions. Cosmetics are products made for beauty, embodying people's aspirations for a better life. I will now invite Mr. Lei to respond to these questions.
Lei Ping：
I will answer these questions. The Regulations on Supervision and Administration of Cosmetics was implemented in 2021. With the enactment of these Regulations, the regulatory framework for cosmetics has gradually developed into a comprehensive and cohesive system. This marks a new chapter in the regulation and development of the cosmetics industry, resulting in continuous improvements within the industry environment.
First, the construction of the regulatory framework has entered a new era. We have organized the formulation and issuance of three departmental rules: the Provisions for Registration and Filing of Cosmetics, the Provision for Supervision and Administration of Manufacturing and Marketing of Cosmetics, and the Provisions for Toothpaste Regulation. More than 20 normative documents and over 40 technical guidelines have been issued, covering cosmetics registration and filing data management, label management, production quality management, online operation management, and supervision of children's cosmetics. This has essentially formed a well-structured regulatory system covering the entire cosmetics industry chain.
Second, new breakthroughs have been made in reforming the review and approval system and developing the safety evaluation system. The provisions have established a system for cosmetics registrants and filing applicants. We have implemented categorized management based on risk levels. We have also formulated safety and efficacy evaluation standards tailored to cosmetics characteristics. Meanwhile, we have strengthened the development of information platforms, improving smart supervision capabilities. Here are some statistics: As of the end of July 2024, there were 20,152 cosmetics registrants and filing applicants nationwide, 3,145 domestic responsible persons for cosmetics, and 5,846 cosmetics manufacturers. There were 1.791 million general cosmetics (1.735 million made in China and 56,000 imported) and 28,326 special cosmetics (23,775 made in China and 4,551 imported).
Third, new progress has been made in post-marketing supervision. A consultation mechanism for cosmetics safety risks has been established to regularly assess and address risks and hidden dangers in the cosmetics sector. We've established and continually improved the monitoring platform for online cosmetics sales, conducting nationwide monitoring of cosmetics sold online. We have strengthened the daily supervision of cosmetics. Over the past three years, more than 20,000 batches of cosmetic products have been sampled annually for national examination, and over 5,000 batches have been sampled annually for national safety risk monitoring. We have also published 22 typical cases of cracking down on illegal and criminal activities concerning cosmetics.
Fourth, we've entered a new phase in developing a system of standards. We established the NMPA Standardization Technical Committee for Cosmetics, further enhancing the management of cosmetics standards. We have continued to advance the formulation and revision of the Cosmetics Safety Technical Standards and actively promoted the revision of relevant mandatory national standards. Since 2021, we have formulated and revised 96 cosmetics standards.
Next, the NMPA will continue to deepen reforms, encourage innovation, strengthen oversight, and crack down on illegal activities. These efforts aim to further contribute to the high-quality development of the "beauty economy." Thank you.
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Xing Huina:
One last question, please.
China Daily:
The issue of pediatric medication has received wide attention and has also been one of the NMPA's priorities in recent years. What progress has been made? What follow-up work will be done by the NMPA? Thank you.
Li Li:
Children are the future of our country and represent our greatest hope. Thanks to the reporter for your interest in pediatric medication. I'll now turn to Mr. Huang to answer this question.
Huang Guo:
Pediatric medication is a common global challenge and a complex issue. Due to the difficulties in research and development, some diseases still lack appropriate treatments. For other conditions, medications exist, but questions remain about their use in children: whether they can be used, how they should be used, and unclear labeling information. In response to these issues, the NMPA has implemented multiple measures to encourage R&D and innovation in pediatric medications, standardize information on pediatric use in drug labels, and meet the clinical needs of young patients.
First, we have implemented a priority review and approval policy to accelerate the marketing of pediatric medications. We have worked with relevant departments to formulate a list of pediatric medications to encourage R&D and applications, achieving good results over the past three years. In 2021, 47 pediatric medications were approved, increasing to 66 in 2022 and 92 in 2023. From January to August this year, we have already approved 49 medications. These figures show a strong momentum of rapid growth in pediatric drug development. For example, we recently expedited the approval of Selumetinib Hydrogen Sulfate Capsules, currently the world's only specialized medication for treating neurofibroma in children. This medication was developed using a global synchronous R&D strategy. Based on international multicenter clinical trial evidence, it received simultaneous global marketing approval through our priority assessment and approval procedure, which will benefit many children.
Second, we have improved medication package inserts and added information on pediatric use. The NMPA has issued the Work Procedures for Adding Pediatric Medication Information to the Package Inserts of Marketed Drugs (for Trial Implementation). This initiative focuses on urgently needed pediatric clinical drugs, encouraging companies to strengthen scientific research while regulatory authorities conduct rigorous evaluations. As a result, information on pediatric use is being added to drug labels, enhancing the safety and efficacy of medications in pediatric clinical practice.
To date, we have issued revision announcements for 49 product specifications across 15 drug varieties in three batches. The newly added pediatric use information covers antineoplastic drugs, such as those for childhood leukemia, which is of particular concern, as well as medications for severe mental disorders in children, including autism, depression, schizophrenia and other serious conditions.
Additionally, we have accelerated improvements to R&D technical requirements, aligning them with international standards. We've issued 21 standards and guidelines for pediatric drug development, comparable to those of regulatory agencies in developed countries. Among these, the Guidance on Real-World Studies to Support Pediatric Drug Development and Regulatory Evaluation of and the Guidance for the Design and Evaluation of Pediatric Drug Palatability are world firsts, placing us at the forefront of global regulatory practices in this field.
Moving forward, the NMPA will continue to prioritize the safety and accessibility of pediatric medications. With the attention and support of society at large, we will further strengthen our support for the R&D and production of pediatric drugs, enhance the supply of medications for children, and provide greater reassurance to parents. Thank you.
Xing Huina:
This concludes today's press conference. Thank you to our speakers and to all members of the media for attending. Goodbye.
Translated and edited by Wang Yiming, Wang Wei, Zhu Bochen, Wang Qian, Wang Ziteng, Huang Shan, Zhang Jiaqi, Zhou Jing, Xiang Bin, Yuan Fang, Yang Chuanli, Li Huiru, Liu Caiyi, Liu Qiang, Xu Kailin, Wang Yanfang, David Ball, Jay Birbeck, and Rochelle Beiersdorfer. In case of any discrepancy between the English and Chinese texts, the Chinese version is deemed to prevail.
