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Read in Chinese
Speakers:
Ms. Jiao Hong, commissioner of the National Medical Products Administration (NMPA)
Mr. Xu Jinghe, deputy commissioner of the NMPA
Mr. Zhao Junning, deputy commissioner of the NMPA
Mr. Huang Guo, 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:
July 5, 2023
Xing Huina:
Ladies and gentlemen, good morning. Welcome to this press conference held by the State Council Information Office (SCIO). This is the 18th briefing in the series "Embarking on the New Journey — A Government Perspective." Today, we have invited Ms. Jiao Hong, commissioner of the National Medical Products Administration (NMPA), to brief you on strengthening drug regulation to ensure drug safety for the public and to take your questions. Also joining us today are Mr. Xu Jinghe, deputy commissioner of the NMPA; Mr. Zhao Junning, deputy commissioner of the NMPA; and Mr. Huang Guo, deputy commissioner of the NMPA.
Now, I'll give the floor to Ms. Jiao Hong for a brief introduction.
Jiao Hong:
Ladies and gentlemen, friends from the media, good morning. I'm very glad to have such an opportunity to meet you here. First of all, on behalf of the NMPA, I would like to express my gratitude to friends from all sectors and the media for your support in advancing drug supervision. Today, my colleagues and I will speak with you about strengthening drug regulation to ensure drug safety for the public.
As we all know, drug safety is of paramount importance, as it directly impacts people's health, life and well-being, as well as the economic development and social harmony of our nation. Since the inception of the NMPA, we have firmly implemented General Secretary Xi Jinping's vital instructions on drug supervision. We have fully aligned ourselves with the major decisions and plans of the CPC Central Committee and the State Council. With a people-centered development approach, we have fully implemented the "four most stringent" requirements (most rigorous standards, strictest supervision, most severe punishment, most serious accountability), and prioritized safety while driving progress. We have continuously deepened the reform of the drug and medical device review and approval system, and strengthened quality supervision throughout the life cycle of drugs. This ensures overall stability in drug safety, propelling our country's transition from a big pharmaceutical nation to a strong pharmaceutical powerhouse, safeguarding and promoting public health.
First, we are committed to strictly preventing risks and effectively maintaining the overall stability of drug safety. We revised the Drug Administration Law and formulated the Vaccination Administration Law, and implemented a robust drug information traceability system. Additionally, groundbreaking reforms have been achieved in the management of vaccines. In 2022, our national vaccine regulatory system passed the third assessment of the World Health Organization (WHO), reflecting the active contribution of Chinese vaccine products to global public health. Special efforts were made to rectify drug safety issues, imposing severe penalties for violations of laws and regulations. Furthermore, we intensified supervision on key products, including those selected in the national centralized procurement process, and continuously improved quality control throughout their life cycle. Thanks to strengthened supervision, the overall pass rate of national drug sampling inspection has risen impressively from 97.1% to 99.4% over the years.
Second, we adhere to innovation-driven approaches to serve and support the high-quality development of the pharmaceutical industry. The review and approval system for drugs and medical devices has been orderly promoted, with an optimized review and approval process, leading to numerous innovative drugs and medical devices being approved for market. Over the past few years, we have approved a total of 130 innovative drugs and 217 innovative medical devices. In the first half of this year, 24 innovative drugs and 28 innovative medical devices were approved for market, effectively meeting the healthcare needs of the people. We implemented the decisions and deployments of the CPC Central Committee and the State Council, issuing the Opinions on Facilitating the Inheritance, Innovation and Development of Traditional Chinese Medicine. Additionally, we promoted the establishment of a review technical standard system tailored to the characteristics of traditional Chinese medicine, resulting in the approval of 31 new traditional Chinese medicines and supporting the inheritance and innovative development of traditional Chinese medicine. We have also made significant progress in the quality and efficacy consistency evaluation of generic drugs, with 615 varieties passing the evaluation, further meeting the people's demands for medicine.
Third, we insist on building a solid foundation and comprehensively strengthening drug supervision capacity. We put into action the Implementing Opinions of the General Office of the State Council on Comprehensively Strengthening the Capacity Building of Drug Supervision to promote scientific, legal, international and modern drug supervision. We completed the formulation and revision of key regulations, including the Drug Administration Law, Vaccination Administration Law, Provisions for Supervision and Administration of Medical Device Distribution, and Provisions for Supervision and Administration of Cosmetics. Additionally, we issued 13 regulations and promulgated and implemented the 2020 Chinese Pharmacopoeia. As a result, the drug supervision system and standard system have been substantially established. To support nationwide regional development strategies, we established four drug and medical device review and inspection sub-centers in the Yangtze River Delta and the Greater Bay Area. Moreover, we implemented the Opinions on Establishing a Team of Professionalized and Specialized Drug Inspectors. The provincial drug inspection teams now have more than 20,000 members, further strengthening the foundation of drug supervision. We comprehensively enhanced international exchanges and cooperation, and the NMPA continuously gained more say and influence internationally.
Ladies and gentlemen, over the past five years, remarkable development and progress has been made in drug supervision, largely due to the strong leadership of the CPC Central Committee with Comrade Xi Jinping at its core and the scientific guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era. This year marks the first year of fully implementing the guiding principles of the 20th CPC National Congress. The NMPA will adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era and take the opportunity of in-depth themed education to fully implement the guiding principles of the 20th CPC National Congress. We will earnestly implement the "four most stringent" requirements and follow the working philosophy of "being politically aware, strengthening supervision, ensuring safety, promoting development and benefiting people's livelihood" to effectively ensure drug safety for the people and strive to establish a modern drug supervision system with Chinese characteristics.
Next, my colleagues and I will address your questions. Thank you.
Xing Huina:
Thank you for your introduction, Ms. Jiao. The floor is now open to questions. Please identify the media outlet you represent before raising your questions.
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CCTV:
Since the reform of the evaluation and approval systems for medicine and medical equipment, the pharmaceutical industry has seen significant innovation progress. Can you discuss the research and development of innovative medicine and medical equipment, as well as their market entries in recent years? Going forward, what policies will be implemented to support innovation, and in which areas will you focus on encouraging innovation and development?
Jiao Hong:
Thank you for your questions. I will answer them. In recent years, the NMPA has deepened the reform of evaluation and approval systems for medicine and medical equipment. It has also rolled out supportive policies to encourage innovation. As you said, judging from the number of drug and medical equipment applications received and approved, including those in the first half of the year, we can see China's robust achievements in innovative medicine and medical equipment. Encouraging innovation is the core of reforming evaluation and approval systems for medicine and medical equipment. In recent years, we have revised and made supporting regulations, including registration management regulations for medicine and medical equipment, and continuously harnessed the policy's benefits. More than 100 medicine products are approved each year through prioritized evaluation procedures. In recent years, by optimizing resources, priority in terms of evaluation has been given to new medicine products that are in urgent clinical need and have proven clinical value. These products include pediatric medications and orphan drugs. Take pediatric medication, which is of significant public concern, for example. In recent years, we have stepped up efforts to revise and make regulations on pediatric medication. A total of 66 pediatric medications were approved to enter the market last year, and 46 pediatric medications were evaluated in the first six months of this year. We have channeled resources to new medicines of proven clinical value as well as medicines and medical equipment in urgent clinical need to promote their market entry. These measures have further encouraged innovation and boosted the high-quality development of biomedicine.
The report to the 20th CPC National Congress systematically expounded on accelerating the establishment of a new development paradigm and redoubling efforts for high-quality development. As we all know, the medical industry is a vigorous industry with a promising future. In recent years, the NMPA has enhanced efforts in China's drug regulatory science action plan, through which drug regulatory work would be more science-based and forward-looking. I will briefly introduce the measures we have taken to encourage innovation. Going forward, we will further consolidate and enhance the development achievements of reforming the evaluation and approval systems.
First, we will further intensify our work on enterprise R&D and innovation. For example, we will improve evaluation and approval procedures for conditional market applications and ensure science-based, strict, procedure-based, and efficient drug evaluation work. Meanwhile, we will further optimize the approval of drugs in urgent clinical need, medical equipment, pediatric medication, orphan drugs, the domestic counterparts of imported drugs, as well as products of core and key technologies. We will prioritize evaluation work and improve the mechanism by integrating research and evaluation. We will step up efforts to make technical guidelines and enhance guidance and services for enterprises' product R&D.
Second, we have constantly advanced the consistency of generic drug evaluation work to ensure quality and efficacy on par with the original drugs. We will continue releasing reference product catalogs and improving relevant technical guidelines. Based on trial work on oral solid preparations and injections, consistency evaluation of other types of generic drugs will be steadily advanced.
Third, we will encourage R&D, as well as the application of radiopharmaceuticals, and reform and improve the evaluation and approval process for these substances. We will make full use of radiopharmaceuticals' role in diagnosing and treating malignant tumors, and cardiovascular and cerebrovascular diseases, in a bid to improve China's capabilities in the research, development, and application of radiopharmaceuticals.
The last point concerns the management of drug package inserts, which is of interest to many. We will advance pilot programs to introduce senior-friendly package inserts so seniors can see them. We will choose some orally-taken drugs and externally-used drugs commonly used by seniors and require drug developers to provide simplified package inserts with larger font sizes. Enterprises will also be encouraged to provide speech synthesis and braille services. Thank you.
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Cover News:
Recent years have seen the fast development of the new industrial form of online sales. Problems emerge as online pharmacy sales bring convenience to people. What are key measures to strengthen security supervision for online medicine, medical equipment, and cosmetics sales? Thank you.
Huang Guo:
Thank you, I will address it. That's a good question. As you pointed out, the development of online sales for medicine, medical equipment and cosmetics has accelerated. According to estimates, the online sales volume of medicine and medical equipment reached 292.4 billion yuan in 2022. It is projected to surpass 350 billion yuan in 2023, suggesting a huge market. The NMPA has planned and taken a series of measures to improve the convenience of online purchases and the quality and security of medicines sold online. These measures primarily fall into the following three aspects.
First, we have improved law-based governance. It is important to know that the internet is not beyond legal jurisdiction. We have promptly established and refined a system of laws and regulations to tackle newly emerged problems. As of now, we have rolled out specialized measures for the administration and supervision of online sales of medicines, medical devices, and cosmetics. These primarily clarify the legal liabilities of supervisory departments, businesses, and third-party platforms, strengthening regulations on online sales monitoring and case handling, highlighting relevant security risk control measures, and enhancing quality control throughout the whole process of online sales. Currently, drug regulatory departments at all levels are enhancing the publicity and implementation of these regulations, further improving supporting policies, and urging involved enterprises to fulfill their legal obligations in accordance with the law.
Second, we have strengthened cyberspace governance. Given that illicit online sales activities are not easy to uncover or track, we have promptly established a mechanism leveraging the strength of the internet for cyberspace regulation, and explored quick respond measures, thus to identify and eliminate potential security risks in online sales in no time. At present, we have achieved comprehensive online monitoring of online sales businesses and major third-party platforms. Moving forward, we will continuously strengthen monitoring and carry out relevant work in a more targeted, accurate, and timely manner. Addressing prominent issues, drug regulatory departments have conducted campaigns to rectify inappropriate practices in online sales of medicines, medical devices, and cosmetics. We promptly follow up leads to investigate and deal with illicit behaviors. We have also implemented a series of measures, such as removing faulty products, closing involved online stores, and revoking the registration of involved enterprises, to further sanitize the online marketplace. As you may have noticed, we have also publicly disclosed two batches of typical cases involving illegal online drug sales to reinforce the warning and deterrent effect, and resolutely crack down on various forms of unlawful online conduct.
Third, we have encouraged co-governance. We have strengthened interdepartmental cooperation, creating a regulatory synergy by promoting collaboration with the Ministry of Industry and Information Technology, Cyberspace Administration of China, National Health Commission, and State Administration for Market Regulation. We harnessed the role of industry associations, established and improved industry norms, and strengthened industry self-regulation. We also encouraged the proactive involvement of media outlets and consumers to build a joint management network throughout the whole society. Hereby, I would like to emphasize that third-party platforms fulfilling their governance responsibilities is critical to improving the quality of online sales and fostering a sound ecosystem for this industry. Notably, major platforms such as Alibaba, JD.com, Meituan, Pinduoduo, and Xiaohongshu should take the lead in implementing platform responsibilities, make full use of their own technological and management advantages, intensify the legal qualification audit and management of their merchants, strengthen cooperation obligations in product recalls, risk disposal, and supervision and inspection, and collaborate with relevant departments to conduct relevant work. I believe that this is the only way for us to collaboratively achieve systematic management and comprehensive governance of online medicine sales.
Thank you.
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Hong Kong Bauhinia Magazine:
Over the past few years, China's medical equipment industry has developed rapidly, with multiple high-level medical devices achieving self-reliance. What measures will be taken to promote the high-quality development of this industry? Thank you.
Jiao Hong:
Thank you for your question. As many of you may have noticed, China's medical equipment industry is currently in a stage of rapid development. Mr. Xu will elaborate on this question.
Xu Jinghe:
Thank you for your question. The CPC Central Committee and the State Council have attached great significance to the innovative development of the medical equipment industry. As General Secretary Xi Jinping has repeatedly emphasized, it's necessary to quickly address weak links in China's high-end medical equipment, make breakthroughs in key and core technologies, and tackle bottlenecks in technology and equipment, to achieve self-reliance and independence in this area. To effectively implement General Secretary Xi Jinping's important instructions, promote the innovative and high-quality development of the domestic medical equipment industry, and better meet people's increasing demand for high-quality healthcare services, the NMPA has mainly concentrated efforts on the following areas of work.
First, we have improved the top-level design and promoted interdepartmental collaboration. The NMPA has jointly issued the "14th Five-Year Plan for National Drug Safety and High-Quality Development" with multiple departments, which clarified the overarching principles, goals, and tasks to promote the high-quality development of the medical equipment industry. We have also jointly issued other documents, including the "14th Five-Year Plan for Medical Equipment Industry Development," with the Ministry of Industry and Information Technology and the National Health Commission to create policy synergy. Furthermore, we have taken the lead in establishing two technological innovation cooperation platforms pertaining to artificial intelligence medical equipment and medical biomaterials, accelerated the transformation and application of scientific and technological achievements in the field of medical equipment, helped to implement an open competition mechanism to select best candidates to undertake key research projects, focused on cutting-edge areas, and made overall plans in advance.
Second, we have further explored how to conduct regulatory work soundly and continually innovated review measures. We launched an action plan to promote regulatory science in medical products administration. Focusing on the frontier areas of technology and regulation, we developed new tools, standards, and methods for medical equipment regulation. We've also established a working mechanism that features early intervention by technical review in the research and development stage. This allows us to provide guidance on advanced medical devices such as ECMO, particle therapy systems, and ventricular assist systems at an earlier stage, accelerating breakthroughs in key and core technologies and driving the overall development of this sector.
Third, we have encouraged innovative medical devices to enter the market and promoted the industry's high-quality development. In recent years, the National Medical Products Administration has focused on innovative medical devices. It has successively issued the Special Review and Approval Procedures for Innovative Medical Products and Priority Approval Procedures for Medical Products so that both innovative products and those meet the urgent needs of clinical treatment can be prioritized and approved efficiently. To date, 217 innovative high-end medical devices, including domestically produced brain pacemakers, carbon ion therapy facility, proton therapy facility, magnetic resonance imaging system, panoramic dynamic PET/CT, third-generation artificial hearts, and artificial blood vessels, have been approved for market launch. This has achieved a breakthrough in the domestic production of high-end medical devices and overcome the challenge where some products were heavily dependent on imports. Most of these products have been used in our current clinical diagnostics and treatment, achieving good results and improving the level of medical diagnosis and treatment.
Next week, we will host the 2023 Medical Device Safety Promotion Week. During that week, we will hold a meeting to discuss the achievements of innovative medical devices. Everyone is welcome to sign up.
With the continuous implementation of various support policies, the medical device industry in China has grown rapidly in recent years, maintaining an average annual compound growth rate of 10.54% over the past five years. It has become the world's second-largest market for medical devices, with increasing industry clustering and international competitiveness. In the next step, the National Medical Products Administration will continue to follow the progress of innovative medical device development, constantly summarizing new experiences, exploring new rules, and introducing new measures. We will approve more and better innovative high-end medical devices for market launch, contributing to the historic leap from a "major medical device producer" to a "strong medical device producer" and enhancing the ability to meet public wellbeing requirements and improve overall satisfaction. Thank you.
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Cnr.cn:
In recent years, medicines for rare diseases have received significant attention. What measures the National Medical Products Administration has taken to encourage innovative research and also the production and supply of medicines for rare diseases? Thank you.
Jiao Hong:
Thank you for your question. Rare disease patients are indeed a group that requires special attention and care, and the management of their medicines is also one of the key areas of focus for the National Medical Products Administration. Now, I will ask Huang Guo to provide more detailed information on this matter.
Huang Guo:
Indeed, we are more confident when the media expresses concern. The inquiries from the media also reflect the general public's awareness and support for treating rare diseases.
As we all know, the prevalence of rare diseases is low. Therefore, the research and development of medicines for these diseases is very challenging, and the market size is small. However, when it comes to every family and each patient, medicines for rare diseases are often lifesaving and cannot be ignored. Therefore, we believe that every medicine for a rare disease deserves our utmost effort.
In recent years, the National Medical Products Administration has seized the opportunity of deepening reforms to the evaluation and approval of medicines, and made significant efforts to accelerate the approval of medicines for rare diseases, striving to provide more options for patients suffering from these illnesses. Due to time constraints, I will primarily introduce two measures.
On the one hand, unleashed policy dividend has sped up the research and development of rare disease medicines. Since 2018, we've provided a special channel in the evaluation and approval link for medicines which are already available in overseas markets and in urgent need for clinical use, including those for treating rare diseases. Under this policy, we've established a specific waiting list, encouraged application of those medicines and expedited their review and approval process. Statistics show that 23 new rare disease medicines have been approved for import and domestic marketing via this special channel. In 2020, we further streamlined the priority review and approval procedure, including new rare disease medicines with significant clinical outcomes into the priority review program. Currently, among all drug marketing applications, the review and approval time for rare disease medicines is the shortest.
On the other hand, we've strengthened technical guidance for enterprises to take fewer detours. Given the exceptionally low incidence of individual rare diseases, the challenges of drug research significantly exceed those of other common diseases. We have provided special policy preferences for new rare disease medicines. Our drug evaluation and approval agency has conducted early participation, interconnected research and evaluation, and provided a full range of services. We've established a special review team to follow up on the research and development of new medicines for rare diseases. Enterprises are allowed to submit research materials on a rolling basis, and a seamless connection mechanism has been established in key phases such as communication, inspection and testing, and comprehensive evaluation. These practices have greatly improved the quality and efficiency of new drug development for rare diseases. We've developed a series of technical guidelines, such as Technical Guidelines for the Clinical Research and Development of Drugs for Rare Diseases and Statistics Guidelines for the Clinical Research and Development of Drugs for Rare Diseases, to guide enterprises in tailoring their approach to the characteristics of rare diseases, promoting flexible designs while maintaining scientific rigor. We encourage them to obtain scientific evidence by making good use of limited patient resources so as to advance clinical research and development.
Through comprehensive measures, China has improved in both the number and speed of rare disease medicine approvals in recent years. To give you some figures, since 2018, China has approved 68 imported and domestically produced drugs for rare diseases. Going forward, the National Medical Products Administration will continue to focus on the needs of rare disease medicines. While ensuring the safety, efficacy, and quality of medicines on the market, we will expedite the evaluation and approval of rare disease drugs, striving to slow the progression of rare diseases and enhance the quality of life for patients.
Thank you!
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The Poster News APP:
Last year, the NMPA launched a special campaign to guarantee drug safety and released a slew of typical cases. At present, what's the drug safety situation in our country? What are the priorities for strengthening drug safety supervision in the next step? Thank you.
Jiao Hong:
Thank you very much for your concern. We all know that we should hold the bottom line to guarantee security and pursue the superior line to promote development. Security is the prerequisite and foundation of development. Here, Mr. Xu will give you more information on this topic.
Xu Jinghe:
Thanks for your concern. Since 2022, the NMPA has earnestly implemented General Secretary Xi Jinping's important instructions on drug safety and launched a one-year thorough campaign to guarantee drug safety following the four most rigorous standards. Last year, 153,600 criminal cases related to medicines, cosmetics, and medical equipment were investigated and punished, and those suspected of committing crimes were promptly transferred to public security organs for investigation according to the law. The NMPA released four batches of 32 typical cases and gave particular supervision over the handling of 29 major cases related to medicines and medical equipment together with the Ministry of Public Security (MPS) and the Supreme People's Procuratorate (SPP) so as to use the cases to explain the law and provide warnings, which effectively ensured the overall stability of the drug safety situation.
In order to constantly and deeply implement General Secretary Xi Jinping's important instructions on drug safety and the deployment and requirement of the education campaign, we summed up our experience of the special campaign on drug safety and carried out another one-and-a-half-year upgrading activity on drug safety this June, focusing on preventing risks, investigating and handling cases, and improving capabilities. By doing so, we have strived to maintain a stable and positive situation in the field of drug safety and resolutely safeguard the health rights and interests of the people. The upgrading activity mainly includes the following three aspects.
The first aspect involves a comprehensive investigation and diffuse of potential risks. We adhere to risk management and keep regulation ahead of risks. First, we guarantee drug safety at the source. We strictly control market access, strengthen the connection between acceptance, inspection, examination, approval, and other sectors, urge enterprises to implement the main responsibility of quality and safety, and help them further enhance the awareness of compliance, the rule of law, and risk. Second, we improve the pertinence, targeting, and effectiveness of our risk and hidden danger investigations. We focus on key products, key links, key objects, and key areas and thoroughly investigate risks and hidden dangers through multi-channel and multi-dimensional measures. Third we resolve safety risks according to the law in a timely manner. For enterprises with high risk or that have been found to have more problems previously, we increase on-site supervision, including unannounced and secret inquiries and inspections, and endeavor to provide more effort to rectify illegal behavior in key areas, such as medical beauty drugs and medical devices.
Second, we crack down on violations of laws and regulations. We have continued to intensify the investigation and handling of illegal cases so that those who violate the law will pay the due price. First, we constantly promote the investigation and handling of illegal cases. We punish both illegal enterprises and the persons in charge, improve the system of supervision of major cases handling, expose typical cases, and release the names of those who partake in illegal and dishonest practices to the public. Joint punishment, industry banning, barred hiring, and other punitive measures have been taken. Second, we constantly strengthen coordination. We increase interconnection among state, provincial, municipal, and county-level drug regulatory departments to eliminate regulatory blind spots and regions. Third, we intensify trans-departmental investigations and case handling. We work with public security organs, procuratorial organs, and people's courts to improve the system to connect administrative law enforcement with criminal justice, further strengthen the linkage between relevant departments, and establish and improve our trans-departmental risk consultation system.
Third, we continuously improve supervision capability. We comprehensively strengthen our supervision capabilities on drug safety and vigorously improve the supervision efficiency. First, we have strengthened institutional building. We have accelerated making and amending relevant laws and regulations and promote the revision of the applicable rules for the administrative punishment of cases relating to medicine. Second, we constantly optimize the supervision system. We perfect the quality management system for drug inspection, promote the integration of inspections and audits, and improve the pharmacovigilance system and its capacity, as well as issue guidelines on accelerating the smart regulation for drug safety at the provincial level. Third we lay a solid foundation for grass-roots supervision. We strengthen the drug supervision force in municipal and county-level market supervision departments and enhance professional law enforcement capabilities. We also actively increase the employment of township drug safety coordinators and drug safety information staff in villages, investigate and defuse rural drug safety risks, and intensify the investigation and handling of rural drug safety cases so as to pragmatically strengthen township and rural drug supervision. Thank you.
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Southern Metropolis Daily:
What has the NMPA done in recent years to promote TCM's inheritance and innovative development, and what has been the effect? Are there any new ideas and measures this year? Thank you.
Jiao Hong:
Thanks for your questions. Promoting TCM's inheritance and innovative development is part of the NMPA's focus. Next, Mr. Zhao will provide more information.
Zhao Junning:
Thank you for your interest in our efforts to promote the inheritance and innovative development of TCM. The advancement and innovative development of TCM is a major decision made by the CPC Central Committee. In recent years, the NMPA has continued to deepen the reform of the review and approval system of TCM, while also consistently enhancing the supervision system for the entire chain and whole life cycle of TCM. It's fair to say that the supervision of TCM and the development of the TCM industry have achieved remarkable results.
First, we have accelerated the introduction of new TCM products. We fully acknowledge the unique characteristics of TCM. In February this year, we released the "Regulations on the Registration Administration of TCM," which adjusted the classification of TCM registration. This led to the creation of a new TCM registration review system that combines TCM theory, human experience, and clinical trials. Thanks to the support of these policies, the number of clinical trials, commercialization applications, and approvals of new Chinese medicines have increased in unison. Since 2018, we have approved 31 new Chinese medicines for marketing, thus meeting the public's medicinal needs.
Second, we have enhanced the standard system of TCM. The NMPA has actively established the TCM standard system with national medicine standards as the backbone, supplemented by provincial standards. We released and implemented the 2020 edition of the Chinese Pharmacopoeia, which comprises 2,711 TCM standards, including 117 new ones and 452 revised ones. For the first time, we also introduced national processing standards for TCM decoction pieces, currently covering 61 varieties. As the pilot program of TCM formula granules has been successfully completed, we have expedited the creation of TCM formula granules standards. Currently, 248 national standards have been established, and nearly 7,000 provincial standards have been filed, involving approximately 700 varieties.
Third, we have improved the assurance of TCM quality and safety. We have insisted on a problem-oriented approach. In January, we issued measures for further strengthening the scientific supervision of TCM to promote its inheritance and innovative development, amounting to a total of 35 measures. In accordance with these measures, we have significantly enhanced supervision across the entire TCM industry chain, carried out special rectification of TCM decoction pieces, and conducted special inspections of production. We have amplified supervision of production and operations, and improved the monitoring of sampling and drug reactions. Additionally, we have also urged drug marketing authorization holders to conduct post-marketing evaluations, revised and improved safety information in instructions, and severely cracked down on violations of laws and regulations. As a result, the overall qualification rate of sampling quality for TCM decoction pieces has increased from 88% in 2018 to about 97% currently, and the overall qualification rate of proprietary Chinese medicine has consistently remained stable at over 98% for a long time.
Moving forward, we will continue to further promote the inheritance and innovative development of TCM, in alignment with the decision-making and strategic deployments of the CPC Central Committee and the State Council.
First, we need to enhance research on the TCM supervision system. We should establish an evaluation and approval system that aligns with the characteristics of TCM and fosters its innovative development. By adopting measures such as integrating research and review, and providing early-stage services for innovative TCM, we need to shift from merely accelerating the back end to speeding up the entire process, thereby further stimulating new vitality for the innovative development of TCM.
Second, we need to establish a standard management system for TCM. Building on the increasingly mature TCM standard system, we've researched and issued special regulations on the standard management of TCM, focusing on constructing a comprehensive TCM standard management system. Given the unique characteristics of TCM, we should also enhance the whole-life-cycle management of TCM standards
Third, we must fully implement the action plan to consolidate and maintain drug safety. We will persist in stringent supervision without laxity and crack down on violations of laws and regulations in the TCM sector. Our goal is to normalize market competition order through impartial oversight and foster a virtuous cycle of safety within TCM.
I would like to inform you that the second national conference on TCM scientific regulation will be held in Shanghai on July 18-19. The conference will concentrate on four main themes: TCM standards, registration, safety supervision, and scientific regulations. We warmly invite our media friends to continue their coverage and support for the conference.
Thank you.
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Zhejiang Daily:
China has promoted the centralized procurement of drugs, proprietary Chinese medicines, and medical devices. What actions and arrangements have been taken to reinforce quality supervision of the selected products? How is the safety and accessibility of medical devices in the procurement process ensured? Thank you.
Xu Jinghe:
Thank you for your question. The NMPA has attached great importance to supervising the centralized procurement of drugs and medical devices. In strict accordance with the principles of risk management, whole-progress control, scientific supervision, and social governance, we have fully implemented the Four Strictest requirements and ensured that pharmaceutical companies bear the primary responsibility for quality and safety issues. We have also ensured that regulatory departments fulfill their territorial obligations at all levels. Moreover, we have strived to serve the overall situation of national centralized procurement and medical reform work.
Since the initiation of national centralized procurement, the NMPA has deployed the supervision work for selected drugs and medical devices every year. We have achieved a three-pronged coverage, including supervision and inspection of drug companies and medical device manufacturers, sampling inspections of in-production products, and monitoring of adverse drug reactions (or adverse events related to medical devices). The National Healthcare Security Administration has highly commended this work. Inspections have encompassed nearly 600 pharmaceutical companies and nearly 170 medical device manufacturers. Meanwhile, product sampling has involved 333 medicine varieties and 15 medical device varieties. This has effectively ensured the quality and safety of drugs and medical devices chosen for procurement. At the same time, we have holistically strengthened the implementation of enterprises' primary responsibilities and local regulatory duties. From the perspective of supervision and inspection, sampling inspection, and monitoring of adverse reactions (or adverse events), the quality and safety of the drugs and medical devices selected for procurement has been well-maintained.
In the next step, the NMPA will continue to increase the supervision of selected products in the national centralized procurement, strengthen risk prevention and control, and comprehensively use means such as supervision and inspection, random inspection, and the monitoring of adverse reaction (adverse event) to strengthen early-warning, early investigation and early handling of hidden risks. In terms of drugs, provincial drug supervisory and regulatory authorities will continue to be required to implement enterprise-customized policies and drug-specific files for selected drug manufacturers and holders in centralized procurement, and further strengthen targeted supervision. As for medical equipment, products selected by national centralized procurement, such as intravascular stents, artificial joints and orthopedic spine products, list management is carried out, and medical devices selected by the national centralized procurement are included in the national sampling inspection. We will continue to improve the supervision ability of drugs, develop innovative supervision approaches, strengthen smart supervision and the analysis and sharing of supervision information data for selected drugs and medical devices in centralized procurement, and continue to improve supervision efficiency through information technology to ensure product quality and safety. Thank you.
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GDToday app Nanfang Plus:
Data shows that the operating income of China's pharmaceutical manufacturing industry in 2022 reached 4.2 trillion yuan. It can be said that China has now entered the ranks of big pharmaceutical countries. What innovative practices have the NMPA adopted in serving the high-quality development of the pharmaceutical industry? Thank you.
Jiao Hong:
Thank you for your question. The high-quality development of the pharmaceutical industry is a common concern to us all. I would like to invite Mr. Zhao Junning to introduce the specific situation.
Zhao Junning:
Thank you for your question. The pharmaceutical field is a highly innovative field. The report to the 20th CPC National Congress pointed out that high-quality development is the top priority of building a modern socialist country in all respects and an essential requirement of Chinese modernization. The next five years will be an important stage for new breakthroughs in China's high-quality economic development. In terms of the pharmaceutical field, China is at an important historical stage of leapfrogging from a big pharmaceutical country to a pharmaceutical powerhouse, from being dominated by generic drugs to being led by innovative ones, and from high-speed growth to high-quality development. To better achieve high-quality development of the pharmaceutical sector, in recent years, the NMPA has been committed to improving drug supervision capabilities and building a scientific, efficient and authoritative drug supervision system in the new era. The main work has been in the following aspects:
First, we have innovated the legal and technical systems. We have accelerated the improvement of the laws and regulations system and technical standards system that support the high-quality development of the industry, formulated high-quality development plans, promoted the implementation of the innovation-driven development strategy in the pharmaceutical field, prioritized the review and approval of innovative drugs and medical devices, and supported the clinical promotion and application of innovative products, in a bid to guide the high-quality development of the pharmaceutical sector.
Second, we have expedited the scientific research of supervision. Since 2019, the NMPA has closely followed the frontiers of international regulatory development, and designated more than 110 NMPA key laboratories in two batches, including well-known domestic universities and scientific research institutions, in accordance with the principles of urgent needs, classified implementation, regional coordination and rational layout. Relying on well-known domestic universities and scientific research institutions in this regard, 14 regulatory science research bases have been established. Aiming to address the key, hot and difficult issues of drug supervision, in conjunction with the NMPA regulatory science research bases, key laboratories and well-known domestic universities and scientific research institutions, we have launched and implemented two groups of 19 key regulatory science projects. At present, a "three-in-one" regulatory science innovation support system has been formed, including regulatory science bases, NMPA key laboratories, and provincial and municipal drug inspection and testing institutions. In the past four years, a total of 187 drug review technical guidelines, inspection and evaluation standards, and inspection and testing methods have been launched through regulatory scientific research, providing strong support for the scientific supervision of drugs.
Third, we have actively participated in international cooperation and coordination. The NMPA has joined organizations such as the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP) and completed an application for "pre-accession" to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to create a good international environment for the high-quality development of the industry.
Next, the NMPA will take high-quality development as the key, and concentrate on the international frontier, scientific and technological innovation and the urgent needs of drug regulation by formulating and implementing a plan on comprehensively strengthening the construction of a drug regulatory scientific research system during the 14th five-year period. We will prioritize the construction of comprehensive key laboratories for drug regulatory science to comprehensively strengthen the national strategic scientific and technological strength in the field of drug regulation. We will launch the research and demonstration of the third group of key regulatory science projects, and strengthen cooperation with the industry. We will continue to develop new tools, new standards and new methods for drug supervision, promote the in-depth development of regulatory scientific research, strengthen technical support for drug supervision, continuously deepen international cooperation, promote the modernization of the drug regulatory system and regulatory capabilities, and fully promote the high-quality development of the pharmaceutical industry.
Thank you.
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Red Star News:
China has adjusted its COVID-19 prevention and control policy, now managing it with measures against Class B infectious diseases. What deployments has the NMPA made in terms of service guarantee for the new stage of COVID-19 prevention and control work and strengthening the quality supervision of COVID-19-related medicine and equipment? Thank you.
Jiao Hong:
Thank you for your question. The NMPA attaches great importance to the review and approval of drugs and medical devices and product quality supervision work involved in COVID-19 prevention and control. I would like to invite Mr. Huang Guo to provide you with the relevant details.
Huang Guo:
Thank you for your question. Since the COVID-19 outbreak, drug regulatory authorities at all levels have thoroughly implemented the decisions and deployments of the CPC Central Committee and the State Council, remained committed to putting the people and their lives first, maintained a state of readiness, adhered to a science-based approach, gone all out to guide and promote the R&D and marketing of vaccines, therapeutic drugs and other products, and spared no effort to do a good job in the quality supervision of COVID-19-related drugs and medical devices. At present, we are continuing to do a good job in related work according to changes in the COVID-19 prevention and control situation and the requirements of measures against Class B infectious diseases. I would like to introduce two aspects:
For one thing, we will continue to provide technical guidance and services for the research and development (R&D) of medicines and vaccines. We will summarize the previous emergency assessment and approval experience, continue to mobilize our best efforts, combine research and assessment, support innovation and R&D, and strive to further enrich our toolbox for combating the pandemic. Previously, the NMPA has successively approved the use or addition of indications of 15 drugs for COVID-19 treatment through a special approval procedure: six chemical medicines (four homegrown ones and two imported ones), two biological products, and three traditional Chinese medicine (TCM) drugs and four TCM prescriptions. We have also given conditional market approvals for five COVID-19 vaccines, among which three have been listed by the WHO for emergency use. Furthermore, we have given emergency approval for China's first homegrown extracorporeal membrane oxygenation (ECMO) device and 151 COVID-19 testing reagents. Next, on the basis of continuously encouraging innovation and R&D, we will urge relevant enterprises to conduct post-marketing studies in accordance with requirements.
For another, we will continue to strengthen the quality regulation of COVID-19 medicines and medical equipment. For homegrown COVID-19 drugs, we have introduced the management requirements of implementing enterprise-specific policies and product-specific registration. We will continue to conduct supervision and inspection of all the enterprises that are producing COVID-19 vaccines with conditional market approval and for emergency use, sending inspectors to all the factories and ensuring tests for lot release. Moreover, we will continue to enhance random inspection and adverse reaction monitoring of other pandemic-related products, including medicines and medical equipment, so as to make sure that the products are safe and effective, and quality controllable. This is the main responsibility that the drug regulatory departments at all levels must constantly focus on. Thank you.
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Xing Huina:
We will have one last question.
China Daily:
In recent years, a slew of laws and regulations for medicine supervision and administration have been issued. Could you brief us on the developments in the formulation, revision, and standard system construction of these laws and regulations? What important laws and regulations will be pushed forward this year? Thank you.
Jiao Hong:
Thanks for your questions. We all know that good laws are a prerequisite for good governance and that standards are significant and fundamental support for industrial development. The NMPA has attached great importance to this respect. I will invite Mr. Xu to answer this question.
Xu Jinghe:
Thanks for your question. Drug safety affects the health and lives of the general public. General Secretary Xi Jinping once proposed the "four most stringent requirements" (the most stringent standards, the most stringent supervision, the most severe penalties, and the most serious accountability) for drug safety, with the first, the most stringent standards, directing the improvement of China's legal and standard system for medicine regulation. Over the past five years and more, the NMPA has firmly implemented the major decisions and deployments of the CPC Central Committee and the State Council, stuck to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, systematically reconstructed the system of medicine supervision and administration laws and regulations, constantly improved the standard system, and upgraded and modernized the system of China's drug supervision and administration laws and regulations with the greatest efforts.
First, we have comprehensively formulated and revised the drug supervision and administration laws and regulations. China's Vaccine Administration Law, adopted in June 2019, is the world's first comprehensive vaccine administration law. The law focuses on the strategic importance and public interest of vaccines, encourages vaccine R&D and innovation, and fully ensures the quality and safety of vaccines. As Mr. Huang just said, the vaccine R&D, production, operation, and application are all going forward under the system of laws and regulations. The newly revised Drug Administration Law, adopted in August 2019, has consolidated and deepened the achievements of drug assessment and approval system reform. It stipulates comprehensively implementing the marketing authorization holder system and fully strengthening the quality control of drugs throughout their life cycle. With the release of the Regulations on the Supervision and Administration of Cosmetics and the revision of the Regulations for the Supervision and Administration of Medical Devices, the "four beams and eight pillars" of the system of medicine supervision and administration laws and regulations have been established.
Second, we have systematically improved the supporting regulations, normative documents, and technical guidelines. China has issued 13 regulations related to drugs, medical devices, and cosmetics, with nearly 40 supporting regulations covering all links in the whole process, including developing, producing, selling and using, drug, medical equipment, and cosmetics. More than 50 important normative documents have been introduced, including an early resolution mechanism for drug patent disputes, post-marketing changes in the management of drugs, clinical trial management for medical devices, and cosmetics labeling management, which has clarified the primary responsibilities of enterprises to ensure quality and safety throughout the entire life cycle in a detailed manner. Technical guidelines for the conditional market approval of drugs, clinical evaluation of medical devices, and the safety assessment of cosmetics, among others, have been issued. At present, there are 459 drug technical guidelines and 559 medical device technical guidelines, which have effectively promoted product R&D and marketing.
Third, we have constantly improved the standard systems. The 2020 Edition of the Pharmacopoeia of China came into force in 2020, forming the national drug standard system centering on the pharmacopoeia and significantly improving drug quality controls and safety. The medical device standard system has been improved and optimized, and the number of effective medical device standards has amounted to 1,937, with the degree of consistency with international standards reaching more than 90%. The standard system framework for cosmetics has been built, and the revision of cosmetics safety technical specifications has been initiated. The standard systems for drugs, medical devices, and cosmetics have continuously become more broad, systematic, and internationally coordinated.
2023 is the first year when we fully implement the guiding principles of the 20th CPC National Congress. The NMPA will continue to strengthen the system of drug supervision and administration laws and regulations, accelerate the revision of the Regulations for Implementation of the Drug Administration Law and the Regulations on the Protection of Traditional Chinese Medicines, promote the release of Provisions for the Supervision and Administration of the Quality of Drug Operation and Application, initiate the revision of Provisions for the Administration of Radioactive Pharmaceuticals, Provisions for Classified Administration of Prescription and Non-prescription Drugs, as well as other laws and regulations, and launch the compilation of the 2025 Edition of the Pharmacopoeia of China. We will enhance systematic support, advance integration and optimization, and develop a coordinated, efficient, systematic, and sound system of drug supervision and administration laws, regulations, and standards so as to better serve and guarantee the high-quality development of the pharmaceutical industry as well as better serve, protect, and promote public health. Thank you.
Xing Huina:
Today's press conference is hereby concluded. Thanks to the four speakers and friends from the media. Goodbye!
Translated and edited by Wang Yiming, Wang Qian, Liu Jianing, Zhou Jing, Qin Qi, Liu Sitong, Ma Yujia, Yan Xiaoqing, Liu Caiyi, Huang Shan, Lin Liyao, Yang Xi, Yan Bin, Yuan Fang, Xu Xiaoxuan, Wang Yanfang, Li Huiru, David Ball, and Jay Birbeck. In case of any discrepancy between the English and Chinese texts, the Chinese version is deemed to prevail.
