In order to thoroughly implement the important instructions and instructions of General Secretary Xi Jinping on drug and medical device supervision and the development of the pharmaceutical industry, comprehensively deepen the reform of drug and medical device supervision, and promote the high-quality development of the pharmaceutical industry, with the approval of the State Council, the General Office of the State Council recently issued the "Opinions on Comprehensively Deepening Drug and Medical Device Supervision Reform to Promote the High-Quality Development of the Pharmaceutical Industry" (hereinafter referred to as the "Opinions"). The relevant content is now interpreted.

1. What is the background of the drafting of the “Opinion”?

In recent years, the CPC Central Committee and the State Council have introduced a series of policies and measures to deepen the reform of drug and medical device supervision and promote the high-quality development of the pharmaceutical industry. In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices", in December 2018, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Opinions on Reforming and Improving the Vaccine Management System", and in April 2021, the General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capacity". Under the strong leadership of the CPC Central Committee and the State Council, the reform of drug and medical device supervision has made important progress and achieved remarkable results, which has effectively promoted the rapid development of my country's pharmaceutical industry and effectively stimulated the vitality of pharmaceutical research and development innovation. Taking 2024 as an example, 48 innovative drugs and 65 innovative medical devices were approved for marketing throughout the year. The number of new drugs under development in my country has jumped to second place in the world, and many domestic innovative drugs have been launched globally. At the same time, there are still some shortcomings in the development of my country's pharmaceutical industry. Compared with developed countries, the foundation of my country's pharmaceutical innovation is not solid, and there is still a gap in the level of innovation.

The Party Central Committee and the State Council attach great importance to the development of the pharmaceutical industry. General Secretary Xi Jinping has repeatedly stressed that the biopharmaceutical industry is a strategic emerging industry related to the national economy, people's livelihood and national security. We must strengthen the construction of basic research and scientific and technological innovation capabilities and firmly grasp the lifeline of the development of the biopharmaceutical industry in our own hands. The Third Plenary Session of the 20th CPC Central Committee clearly proposed reform measures such as improving the drug safety responsibility system, promoting the development of the biopharmaceutical and medical equipment industries, improving the mechanism to support the development of innovative drugs and medical devices, improving the mechanism for the inheritance and innovation of traditional Chinese medicine, and promoting the coordinated development and governance of the "three medical services". In order to thoroughly implement the decisions and arrangements of the Party Central Committee and the State Council, the State Drug Administration, together with the Central Organization Department, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Finance, the Ministry of Human Resources and Social Security, the Ministry of Commerce, the National Health Commission, the State Administration for Market Regulation, the National Intellectual Property Administration, the National Medical Insurance Administration, the State Administration of Traditional Chinese Medicine and other relevant departments, drafted the "Opinions" on the basis of comprehensively sorting out policies, conducting in-depth investigations and studies, widely listening to opinions from all parties, and systematically summarizing the achievements of the reform of the drug and medical device review and approval system in the past decade. The Opinions were reviewed and approved by the State Council Executive Meeting and issued and implemented by the General Office of the State Council. The release of the "Opinion" will deepen the reform of the entire process of drug and medical device supervision, accelerate the construction of a unified national market in the field of drugs and medical devices, create an innovation ecosystem with global competitiveness, promote my country's transition from a major pharmaceutical country to a pharmaceutical power, and better meet the people's demand for high-quality drugs and medical devices.

2. What are the overall considerations and main contents of the “Opinion”?

The Opinions are based on the actual characteristics of drugs and medical devices as special commodities for curing diseases and saving lives, closely follow the development characteristics of the pharmaceutical industry as a representative industry of new quality productivity, and on the basis of maintaining the stability and continuity of regulatory policies, adapt to the urgent needs of industrial innovation, and study and propose more comprehensive reform measures for drug and medical device supervision. The Opinions are divided into six parts. The first part is the overall requirements, which clarifies the guiding ideology and main goals of the reform, and proposes that by 2027, the laws and regulations on drug and medical device supervision will be more perfect, and the regulatory system, regulatory mechanism, and regulatory methods will better meet the needs of pharmaceutical innovation and high-quality development of the industry. The quality and efficiency of the review and approval of innovative drugs and medical devices will be significantly improved, the supervision of the whole life cycle will be significantly strengthened, the quality and safety level will be comprehensively improved, and a regulatory system that is compatible with pharmaceutical innovation and industrial development will be established. By 2035, the quality, safety, effectiveness, and accessibility of drugs and medical devices will be fully guaranteed, the pharmaceutical industry will have stronger innovation and creativity and global competitiveness, and regulatory modernization will be basically achieved. The second to sixth parts propose 24 reform measures in five aspects.

First, in order to further enhance the original innovation of my country's pharmaceutical industry and seize the strategic window period when the industry is in the process of making the transition from imitation innovation to original innovation, the "Opinions" proposes to improve the review and approval mechanism to fully support major innovations, increase support for the research and development and innovation of traditional Chinese medicine, give play to the leading role of standards in the innovation of drugs and medical devices, improve the relevant system for the protection of intellectual property rights of drugs and medical devices, and actively support the promotion and use of innovative drugs and medical devices. These measures will encourage and stimulate innovation from the perspective of institutional design and provide a transparent, stable and predictable policy environment for industrial development.

Second, to further improve the efficiency of review and approval, the "Opinion" proposes to strengthen pre-registration guidance for drugs and medical devices, accelerate the approval and marketing of drugs and medical devices urgently needed in clinical practice, optimize the review and approval mechanism for clinical trials, optimize the review and approval of drug supplementary applications, optimize drug and medical device registration inspections, and accelerate the review and approval of drugs and medical devices for rare diseases. Measures such as these will strive to shorten the review and approval time limit and further accelerate the process of bringing innovative products to market.

Third, in order to cope with the new challenges brought by product innovation, technological innovation and business model innovation to the supervision of drugs and medical devices, the "Opinion" proposes measures such as promoting the batch release authorization of biological products (vaccines), promoting the quality improvement of generic drugs, promoting the informatization of the production and inspection processes of pharmaceutical companies, improving the efficiency of drug and medical device supervision and inspection, strengthening the vigilance work of innovative drugs and medical devices, and improving the quality and efficiency of the supervision of new business models of pharmaceutical distribution to guide the transformation and upgrading of the industry.

Fourth, in order to strengthen international trade cooperation and fully consider the main policy demands currently faced by multinational pharmaceutical companies in their operations in China, the "Opinions" propose measures such as deepening the transformation and implementation of international common regulatory rules, exploring segmented production models for biological products, optimizing the import approval of drugs and medical devices, and supporting the export trade of drugs and medical devices, to further stabilize the expectations of foreign-invested enterprises, support and encourage multinational pharmaceutical companies to expand their investment in China, and introduce advanced technologies and R&D experience.

Fifth, in order to build a modern regulatory system with Chinese characteristics that is compatible with medical innovation and industrial development, the "Opinions" proposes measures such as continuously strengthening regulatory capacity building, vigorously developing drug regulatory science, and strengthening regulatory informatization. By continuously strengthening capacity building, the scientific, legal, international and modern level of drug and medical device supervision will be continuously improved.

3. What are the main considerations for implementing “early intervention, one policy for each enterprise, full-process guidance, and joint research and review”?

In recent years, in accordance with the decisions and arrangements of the CPC Central Committee and the State Council on deepening the reform of the drug and medical device review and approval system, the National Medical Products Administration has established four fast-track approval channels in the field of drugs, namely, breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval, and three fast-track approval channels in the field of medical devices, namely, the registration procedure for innovative products, the priority registration procedure, and the emergency registration procedure. Against the backdrop of a substantial increase in the amount of review tasks, the review and approval time limit for innovative drugs and innovative medical devices has been significantly shortened, and the vitality of drug and medical device research and development innovation has been continuously enhanced. In order to better meet the needs of industrial innovation and development, further increase support for innovative drugs and innovative medical devices, and draw on the experience of review and approval for key products during the COVID-19 epidemic, the "Opinion" proposes that in accordance with the requirements of "early intervention, one policy for each enterprise, full guidance, and coordinated research and review", more review and approval resources should be allocated to innovative drugs and innovative medical devices that implement the requirements of the country's major strategic layout, achieve major scientific breakthroughs, meet the urgent needs of major public health emergencies, or have significant clinical advantages. Communication and exchanges should be strengthened throughout the entire process of clinical trials, registration applications, verification and inspection, review and approval, and personalized guidance should be provided to enable registration applicants to lay a solid research foundation as early as possible, accelerate the transformation process of products from research and development to market launch, and enter the market faster.

4. How to encourage new drug research and development from the perspective of strengthening intellectual property protection?

New drug research and development is a high-risk, high-investment, and long-term process. Strengthening the intellectual property protection of innovative drugs is the core demand of pharmaceutical innovation companies. From the perspective of patent protection, the "Opinions" emphasizes the need to accelerate the patent layout of original achievements in drugs and medical devices, and to improve the patent quality and transformation and utilization efficiency of the pharmaceutical industry. On this basis, the "Opinions" further proposed two important institutional innovations: strengthening drug data protection and improving the market exclusivity system.

Article 34 of the current "Regulations for the Implementation of the Drug Administration Law" stipulates that the state shall protect the test data and other data obtained and not disclosed by the producers or sellers who have obtained the license to produce or sell drugs containing new chemical ingredients. The "Opinion" further expands the scope of data protection and clarifies that when some drugs are approved for marketing, the test data and other data obtained and not disclosed by the registration applicants shall be given a certain data protection period by category. The State Drug Administration is actively promoting the revision process of the "Regulations for the Implementation of the Drug Administration Law" and is speeding up the study of specific data protection measures, making detailed provisions on the protection methods, scope of protection, protection categories, protection period, etc., to promote the implementation of the data protection system.

The drug market exclusivity system is a policy incentive, and drug regulatory agencies in Europe and the United States have relatively mature practical experience. At present, my country grants market exclusivity protection to the first chemical generic drugs and some traditional Chinese medicines that successfully challenge patents and are first approved for marketing. The "Opinions" require the improvement of the market exclusivity system and the granting of a certain market exclusivity period to qualified drugs for rare diseases, drugs for children, the first chemical generic drugs and exclusive traditional Chinese medicines. By granting a certain period of market exclusivity to a few varieties, pharmaceutical companies can obtain reasonable returns based on market value, which will effectively encourage companies to increase R&D and innovation efforts, fill the gap in domestic therapeutic drugs, and meet urgent clinical needs.

      5. How to further encourage the launch of innovative drugs and medical devices and continue to release the dividends of the review and approval system reform?

Since the reform of the review and approval system for drugs and medical devices in 2015, the State Drug Administration has continuously improved the review and approval efficiency of drugs and medical devices through a series of important measures, such as establishing a channel to accelerate the registration of listing, reforming the drug clinical trial supervision system, and implementing the related approval system. On the basis of comprehensively sorting out and summarizing the experience of deepening the reform of the review and approval system and encouraging innovation in drugs and medical devices, the Opinions proposes to coordinate the supervision resources at the national and provincial levels through new measures such as strengthening pre-registration guidance, strengthening the capacity building of technical support institutions, strengthening the construction of review and inspection sub-centers, and promoting the batch release authorization of biological products (vaccines), so as to tilt more review and approval resources to innovative drugs and medical devices, further release policy dividends, and encourage the listing of innovative drugs and medical devices.

First, strengthen pre-registration guidance. Shorten the waiting time for communication and exchange on clinical trials of innovative drugs that are urgently needed in the clinic. Carry out multi-channel and multi-level communication, run the "Drug Review Cloud Classroom" and "Device Review Cloud Classroom" well, establish a regional communication mechanism, give full play to the role of the review and inspection sub-centers and the central-local linkage mechanism of medical device innovation services, strengthen the publicity and interpretation of registration and application rules, and improve the quality and efficiency of R&D applications.

Second, optimize the clinical trial review and approval mechanism. After the provincial drug regulatory authorities submit an application and the National Medical Products Administration agrees, a pilot program will be carried out in regions with rich experience in clinical trial implementation and sound supporting management policies, and the review and approval of eligible drug clinical trial applications will be completed within 30 working days. The review and approval period for medical device clinical trials will be shortened from 60 working days to 30 working days. Optimize the bioequivalence test filing mechanism.

The third is to optimize the review and approval of drug supplementary applications. After the provincial drug regulatory authorities submit an application and the National Medical Products Administration agrees, a pilot reform of the optimization of the review and approval procedures for drug supplementary applications will be carried out in regions with the ability and conditions. The pilot provincial drug regulatory authorities will provide pre-initiative guidance, verification, inspection and filing services for major drug change declarations within their administrative regions. The Drug Review Center will accept and review and approve pre-initiative service varieties in accordance with the principle of not lowering standards and not reducing procedures, and shorten the review period for supplementary applications that previously required verification and inspection from 200 working days to 60 working days.

Fourth, shorten the time limit for batch release of some varieties. Taking into account the maturity of production technology, the convenience of inspection methods and the urgency of vaccine use, the time limit for batch release of seasonal influenza vaccines, which pose a great threat to the health of children and the elderly and have a strong timeliness, will be shortened from 60 working days to within 45 working days.

Fifth, optimize drug registration inspection. On the one hand, in order to reduce the pressure on applicants to prepare samples, the amount of samples required for each batch of registration inspection will be reduced from 3 times the amount of full inspection to 2 times. On the other hand, considering the small production volume of drugs for the treatment of rare diseases, the number of registration inspection batches for drugs for the treatment of rare diseases will be reduced from 3 batches to 1 batch.

Sixth, explore and carry out pilot projects for segmented production of innovative and clinically urgently needed biological products. Pilot projects will be carried out in provincial administrative regions where the CPC Central Committee and the State Council's regional coordinated development strategy proposes to explore segmented production tasks for biological products, as well as in provincial administrative regions where biopharmaceutical industries are concentrated, there is indeed project demand, and the regulatory capacity of biological products is strong. Under the premise that product quality is controllable, innovative products with special requirements for production processes, facilities and equipment are allowed to be produced in segments first. By optimizing resource allocation, strengthening high-level professional division of labor, improving the response speed of the supply chain, promoting products to be listed as soon as possible, and better meeting the urgent needs of clinical medication.

6. What are the key reform measures in the field of traditional Chinese medicine?

The "Opinions" put forward reform measures related to traditional Chinese medicine in terms of research and development, production, operation, use and supervision, establish a traditional Chinese medicine supervision system that conforms to the characteristics of traditional Chinese medicine, and support the inheritance and innovative development of traditional Chinese medicine throughout the entire chain.

In the research and development stage, we emphasize increasing support for the R&D and innovation of traditional Chinese medicine, further improving the evidence system for the review of traditional Chinese medicine characteristics that combines traditional Chinese medicine theory, human experience and clinical trials, and establishing a mechanism for medical institutions to collect and organize human experience data in a standardized manner. On the one hand, we actively support the transformation of famous old Chinese medicine prescriptions with human experience and traditional Chinese medicine preparations in medical institutions into new traditional Chinese medicines. New traditional Chinese medicine compound preparations developed in accordance with the "three-in-one" traditional Chinese medicine registration review evidence system do not need to conduct non-clinical effectiveness studies if human experience can provide supporting evidence in clinical positioning, screening of applicable populations, course of treatment and dosage, etc., and only necessary clinical trials can be carried out to support registration and listing. On the other hand, we encourage "secondary development" of Chinese medicines that have been marketed, and encourage the use of new technologies, new processes and new dosage forms that meet the characteristics of the products to improve the varieties of traditional Chinese medicines that have been marketed.

During the registration process, priority review and approval will be given to applications for substitutes for rare and endangered medicinal materials, the review and approval of traditional oral Chinese medicines that have been marketed in Hong Kong and Macao will be simplified, the management of imported medicinal materials will be optimized, and the import of high-quality overseas medicinal resources will be expanded.

In the production process, we will promote the deep integration of new-generation information technology and the pharmaceutical industry chain, support the digital transformation of Chinese medicine production enterprises, improve the level of informatization of the management system, and develop new quality productivity of Chinese medicine according to local conditions.

In the operation link, the convenience of Chinese medicine circulation will be improved, and it will be clearly stated that Chinese herbal medicines prepared in accordance with provincial processing specifications can be sold across provinces as required, and Chinese herbal medicine formula granules produced in accordance with national drug standards can be sold directly across provinces.

In terms of supervision, we will improve the supervision system of traditional Chinese medicine that is in line with the characteristics of traditional Chinese medicine, and improve the scientific research and transformation mechanism of traditional Chinese medicine supervision. The Opinions also proposed to strengthen international exchanges and cooperation on traditional Chinese medicine resources, actively carry out the publicity and communication of international regulatory policies, and support the registration and listing of traditional Chinese medicines with clinical advantages overseas.

7. What are the key reform measures in the field of medical devices?

The "Opinion" comprehensively uses regulatory policy tools such as standards, review and approval, inspection and testing, monitoring and evaluation to fully promote the innovative and high-quality development of the medical device industry.

In terms of standards, we will give full play to the leading role of standards in medical device innovation, further promote the national action plan for improving medical device standards, optimize the medical device standard system, and study and establish cutting-edge medical device standardization technology organizations such as artificial intelligence and medical robots. We will strengthen the formulation of standards for traditional Chinese medical devices.

In terms of review and approval, establish a regional communication mechanism to strengthen pre-registration guidance for medical devices; give priority to review and approval of high-end medical equipment and high-end implantable medical devices such as medical robots, brain-computer interface equipment, radiotherapy equipment, medical imaging equipment, and innovative Chinese medicine diagnosis and treatment equipment that are urgently needed in clinical practice. Promote the evaluation of the capabilities of medical device review agencies and reviewers in provincial drug regulatory departments.

In terms of inspection and testing, a green channel for priority inspection of innovative medical devices will be opened up, and medical devices urgently needed in clinical practice will be inspected upon receipt; the efficiency of medical device supervision and inspection will be improved, and combined inspections will be carried out on Class II and Class III medical device manufacturers that also produce Class I medical devices.

In terms of monitoring and evaluation, we will improve the medical device adverse event monitoring platform based on the risk characteristics of innovative medical devices, enhance the level of intelligent alert for innovative medical devices, and strengthen active monitoring of innovative medical devices after they are put on the market.

8. What reform measures will be implemented to encourage the research and development and innovation of drugs and medical devices for rare diseases?

Strengthening the prevention and treatment of rare diseases is related to the health and well-being of the people. In order to accelerate the research and development and marketing of drugs for rare diseases and better meet the people's demand for drugs, the "Drug Administration Law" stipulates that new drugs for the prevention and treatment of rare diseases shall be given priority review and approval. On this basis, the "Opinions" put forward reform measures to further promote the research and development and innovation of drugs and medical devices for rare diseases.

First, optimize clinical trial requirements. For rare disease drugs that are urgently needed in clinical practice and have been marketed overseas but not in China, we can make full use of clinical data at home and abroad to reduce or exempt domestic clinical trials for research that meets the requirements.

The second is to optimize the dosage of drug registration inspections, reducing it from three batches to one batch, and from three times the dosage of full-item inspections per batch to two times per batch, significantly reducing the cost of submitting samples for registration inspections.

The third is to optimize the way to initiate registration verification. Based on product risks, the pre-market registration verification and post-market inspection of imported rare disease drugs can be organically combined and coordinated to reduce the waiting time for overseas verification.

Fourth, explore the possibility of specific medical institutions importing urgently needed drugs and medical devices for rare diseases that have not been registered and marketed domestically.

Fifth, national medical centers are encouraged to increase the allocation and use of drugs and medical devices for rare diseases.

Sixth, high-level medical institutions are encouraged to independently develop and use diagnostic reagents for rare diseases that have no similar products on the market in China, so as to better meet the needs of rare disease diagnosis.

9. How does the “Opinion” implement the Party Central Committee’s decision-making and deployment to “promote the coordinated development and governance of medical care, medical insurance, and pharmaceuticals”?

The Decision of the CPC Central Committee on Further Comprehensively Deepening Reform and Promoting Chinese-style Modernization adopted at the Third Plenary Session of the 20th CPC Central Committee made systematic arrangements for deepening the reform of the medical and health system, and explicitly required the promotion of coordinated development and governance of medical care, medical insurance, and medicine. When reviewing the Opinions, the State Council Executive Meeting pointed out that it is necessary to follow up on policies in medical insurance, medical care, prices, etc. in a timely manner, and work together to promote the high-quality development of the pharmaceutical industry. The Opinions thoroughly implement the decisions and arrangements of the CPC Central Committee and the State Council, closely follow the promotion and use of innovative drugs and medical devices, and put forward a series of reform measures to promote the upgrading of the entire industry chain of pharmaceutical research and development, production, operation, and use. In terms of medical care, we will increase the comprehensive clinical evaluation of innovative drugs, strengthen the analysis and application of evaluation results, and encourage medical institutions to purchase and use innovative drugs and medical devices. In terms of medical insurance, we will study and pilot the self-evaluation of newly listed drug companies based on pharmacy and clinical value, optimize the online service for newly listed drugs, improve the adjustment mechanism of the medical insurance drug catalog, study and standardize the medical insurance medical consumables catalog and medical service project catalog, and include qualified innovative drugs and medical devices in the medical insurance payment scope according to procedures, improve the multi-level medical security system, and improve the diversified payment capacity of innovative drugs. In addition, in terms of disseminating information on innovative drugs and medical devices to the public, publishing and updating the online version of the Chinese Pharmacopoeia, accelerating the approval and listing of drugs and medical devices urgently needed in clinical practice, strengthening vigilance work on innovative drugs and medical devices, promoting informatization transformation of blood product production, and promoting the implementation of unique identification of medical devices, we will further strengthen the coordination and linkage of medical care, medical insurance, and medicine, effectively enhance work synergy, improve governance efficiency, and jointly promote the high-quality development of the pharmaceutical industry.

10. How do you understand the Opinion’s proposal to improve the compliance level of the pharmaceutical industry through efficient and strict supervision?

The responsibility for drug safety is heavier than Mount Tai. From international experience, drugs and medical devices are highly professional and technical, and the safety and effectiveness of products are closely related to the physical health and life safety of the people. The pharmaceutical industry is one of the areas most strictly regulated by the government in major countries in the world. In my country, the drug regulatory authorities have always insisted on ensuring the quality and safety of drugs and medical devices as their most fundamental responsibility, and have taken multiple measures to implement the most stringent supervision. To this end, the "Opinion" proposes to improve the compliance level of the pharmaceutical industry through efficient and strict supervision, and to carry out precise guidance, regulation, supervision and services for pharmaceutical production and operation entities.

First, promote the authorization of batch release of biological products (vaccines). On the basis of full risk assessment, gradually expand the scope of inspection and testing institutions and varieties of provincial drug regulatory departments authorized to implement batch release of biological products (vaccines).

Second, promote the improvement of generic drug quality. Encourage the high-quality development of generic drugs, optimize the review and verification mechanism of generic drugs, support enterprises with high information level, strong quality assurance and risk prevention and control capabilities to accept commissions, and orderly expand the scope of generic drug quality and efficacy consistency evaluation.

The third is to promote the informatization of production and inspection processes in pharmaceutical companies. Support the digital transformation of pharmaceutical and medical device manufacturers, accelerate the improvement of product quality management information systems, use information technology to collect and record production parameters, and gradually achieve full-process monitoring from material storage to product release, with special emphasis on information management requirements for manufacturers of high-risk products such as vaccines and blood products.

Fourth, improve the efficiency of drug and medical device supervision and inspection. Reasonably determine the inspection frequency based on the risk level of the enterprise and product to reduce repeated inspections. Encourage national and provincial drug regulatory authorities to jointly carry out on-site registration inspections and production quality management compliance inspections involving manufacturers.

Fifth, strengthen the vigilance of innovative drugs and medical devices. Guide and urge the holders of innovative drug marketing authorizations to establish and improve drug vigilance systems, and continue to conduct post-marketing research on innovative drugs. Strengthen active monitoring of innovative drugs and medical devices after they are marketed.

Sixth, improve the quality and effectiveness of supervision of new formats of pharmaceutical distribution. Emphasize the need to strengthen supervision of online sales and consolidate the responsibilities of third-party online trading platforms. Support wholesale enterprises to effectively integrate storage and transportation resources, promote cross-provincial multi-warehouse linkage, and promote the transformation and upgrading of wholesale enterprises. Optimize the licensing process and increase the retail chain rate.

11. What arrangements does the "Opinion" make to support the pharmaceutical industry in expanding opening-up and cooperation?

The Third Plenary Session of the 20th CPC Central Committee emphasized that we must adhere to the basic national policy of opening up to the outside world, promote reform through opening up, enhance the ability to open up in expanding international cooperation, and build a new open economic system with a higher level. The Opinions thoroughly implement the decisions and arrangements of the CPC Central Committee and the State Council, focus on national strategic needs, focus on the opening up of the pharmaceutical industry, and propose new institutional opening-up measures from a regulatory perspective. These measures focus on giving full play to the role of drug regulatory authorities, and will work together with the policies of macroeconomic departments such as development and reform and commerce to further encourage multinational pharmaceutical companies to expand their investment in China and support Chinese pharmaceutical companies to participate in global competition in accordance with international rules.

First, we will further promote the transformation and implementation of international common regulatory rules. We will continue to promote the coordination of technical requirements for drug review with the rules of the International Council for Harmonization of Technical Regulations for Pharmaceuticals for Human Use, support the development of international multi-center clinical trials, and promote the simultaneous development, application, review, and marketing of global drugs in my country. We will actively promote the transformation and implementation of the technical guidelines of the International Medical Device Regulators Forum and the Global Council for Harmonization of Medical Device Regulations in my country.

Second, we will optimize the import approval of drugs and medical devices. We will allow pre-approval commercial-scale batches of drugs that meet the requirements to be imported and sold, shortening the time difference from approval to production and supply to the Chinese market. We will optimize the review and approval process for overseas-to-domestic production, and support foreign-invested enterprises in bringing original research drugs and high-end medical equipment into domestic production.

Third, we will support eligible overseas drug marketing authorization holders to explore cross-border segmented production of innovative and clinically urgently needed biological products in the form of self-built production capacity or commissioned production under a unified drug quality management system, and promote the deep integration of domestic production into the global supply chain.

Fourth, support the export trade of medicines and medical devices. Accelerate the process of joining the international drug inspection cooperation program and promote the quality assurance level of my country's pharmaceutical industry to match the international advanced level. Broaden the scope of issuing export sales certificates for medicines and medical devices. For medicines and medical devices produced by qualified enterprises in accordance with production quality management standards, whether they have been registered and listed in my country, they can be issued export sales certificates to support my country's pharmaceutical products to enter the international market.

12. How to build a regulatory system that adapts to industrial development and security needs?

Drug safety is produced and managed. Strengthening the supervision of drugs and medical devices is necessary to protect and promote public health. Only strong supervision can protect a strong industry. At present, my country is in the historical process of leapfrogging from a pharmaceutical power to a pharmaceutical power. In order to build a modern supervision system with Chinese characteristics that is compatible with pharmaceutical innovation and industrial development, the Opinions proposes a number of measures.

First, continue to strengthen regulatory capacity building. Optimize the setting of regulatory technical support institutions, strengthen professional team building, and enrich high-quality professional technical forces. Strengthen the capacity building of review and inspection sub-centers, and gradually give more responsibilities to review and inspection sub-centers that meet the capacity standards. Encourage local governments to improve local regulatory systems and mechanisms in light of the actual development of the pharmaceutical industry. Encourage provincial-level drug regulatory departments with conditions to pilot more drug and medical device review and other work.

Second, vigorously develop drug regulatory science. With the National Key Laboratory of Drug Regulatory Science as the leader, strengthen the construction of innovative research bases for drug regulatory science. Improve the mechanism for the transformation of research results and the incentive mechanism for scientific researchers, and accelerate the development of new tools, methods, and standards to support regulatory decision-making.

Third, strengthen the construction of regulatory informatization. Promote the online handling of all links and processes of drug and medical device regulatory government services from application, acceptance, review to certification. Improve the national drug smart supervision platform, strengthen the data collection and management of product files and credit files, and explore the implementation of penetrating supervision. Strengthen the construction of the full-chain drug traceability system, and gradually achieve traceability of the entire process of production, circulation, and use.

source:National Drug Administration website

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