Chinese(GB)     
Contact CFDA
   
HOME ABOUT CFDA WHAT'S NEW LAWS & REGULATIONS REGULATORY GUIDE DATA SEARCH SITE MAP
  Search      
Home >> What's New  
What's New
Speech Made by Minister Bi Jingquan at the National Videophone Conference on Deepening the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation
2017-10-12

Speech Made by Minister Bi Jingquan at the National Videophone Conference on Deepening the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation
(October 10,2017)


On October 1, the General Office of Central Committee of CPC and the General Office of the State Council promulgated the Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation (TING ZI [2017] 42). This document was made public on October 8. On October 9, 2017, China Food and Drug Administration organized the Press Conference and Vice Minister Wu Zhen made an interpretation of this document to the media. Today, CFDA holds this Videophone Conference in order to make necessary arrangements for the implementation of the Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation. Now, I have the following three topics.
1.To fully understand the importance and necessity of deepening reform and encouraging innovation.
Food and drug safety is related to the health and life of 1.3 billion people in China, which is an important and basic problem of livelihood, as well as a significant and strategic problem of social and economic development. Ever since the fourth quarter of 2016, CFDA has organized a taskforce to research on the policy to encourage drug and medical device innovation. On May 9 and 10, CFDA publicized the draft for public comments. On May 10, the Office of the Central Leading Group for Comprehensively Deepening Reform listened to CFDA's report on the draft. On May 12, the Legal Affair Office of the National People’s Congress listened to CFDA's report. On May 19, Vice Premier Wang Yang organized a specific meeting so as to listen to the report and to coordinate on relevant policies. At the end of May, CFDA submitted the draft Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation to the State Council for approval. On July 19, the 37th Meeting of the Central Leading Group for Comprehensively Deepening Reform passed this draft and required the General Office of Central Committee of CPC and the General Office of the State Council to promulgate the Opinions. During the development of this document, we have received great support given by the Central Staffing Office, National Development and Reform Committee, Ministry of Science and Technology, Ministry of Finance, Ministry of Human Resource and Social Affairs, National Health and Family Planning Committee, State Intellectual Property Office, the Legal Affair Office of the State Council, etc. , which has shown the great importance on food and drug regulation attached by the Central Committee of CPC and State Council, as well as the development rationale with peoples’ interest as the core. As a result, every participant of this meeting should fully understand the importance of deepening reform and encouraging innovation, further strengthen the sense of responsibility, sense of urgency and sense of mission, carefully study the document and enhance its implementation.
Firstly, to deepen reform and to encourage innovation is an urgent need to fulfill General Secretary Xi Jinping’s strategic thoughts on food and drug regulation and to ensure the safety and quality of the drug. General Secretary Xi Jinping has made several instructions and comments on food and drug regulation. In May 2015, during the 23rd Collective Learning of the Political Bureau of the CPC Central Committee, General Secretary Xi pointed out that the establishment of science-based and perfect food and drug safety governance system shall be speeded up, so as to strictly protect every defense line from farm to table, from laboratory to hospital. In July 2017, the 37th Meeting of the Central Leading Group for Comprehensively Deepening Reform emphasized that the review and approval system shall be reformed and perfected, so as to stimulate the innovation and vitality of the pharmaceutical industry. We shall reform the clinical trial management system, speed up the review and approval for market authorization, to promote the consistency evaluation on the quality and efficacy generic, so as to perfect the food and drug regulatory system, to encourage the industry to improve its capacity for innovation and R&D, to speed up the marketing of new drugs and good drugs and to fulfill the clinical urgent needs. Premier Li Keqiang also emphasized that the drug research and development, especially for important new drugs, shall be promoted, the update of medical device industry shall be encouraged, so that the situation of import-reliance on innovation medicines and sophisticated medical devices shall be changed as soon as possible.
In August 2015, the State Council promulgated the Opinions on Reforming Drug and Medical Device Review and Approval System (GUO FA [2015]44). In February 2016, the General Office of the State Council promulgated the Opinions on the Implementation of Consistency evaluation on the Quality and Efficacy of Generics (GUO BAN FA [2016]8). In February 2017, the State Council issued the 13th Five-Year Plan on National Drug Safety (GUO FA [2017]12). This time, the General Office of Central Committee of CPC and the General Office of the State Council promulgated the Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation, which has comprehensively summarized and deepened the two-year experience on review and approval system reform and has intensively reflected the strategic decision on food and drug regulation by the Central Committee of CPC and the State Council.
Secondly, to deepen reform and to encourage innovation is an urgent need to fulfill the public access to new, good and affordable drugs. We shall rely on innovation in order to fulfill the urgent clinical needs for drugs. The Chinese modern pharmaceutical industry has a late start and week basis. During the past ten more years, Chinese government has made great effort to promote the implementation and standardization of good practice on drug manufacturing and distribution, but the situation of low-level duplication on pharmaceutical industry is still serious and has a quite big gap from the international advanced level. The first problem is the weak domestic innovation. The new chemical or biological products researched by domestic pharmaceutical industry, were still imitations or slight improvements on global marketed innovative medicines. The real-sense innovative medicines developed by China were very limited, for instance, the anti-malaria drugs artemisinine. In 2016, the total investment on research and development from domestic pharmaceutical industry accounted for 42 billion RMB, while the R&D investment from one of the multinational companies would reach billions of US dollars. The second problem is the lack of imported new drugs. From 2001 to 2016, the US FDA has approved 433 new drugs, while only 133 of them have been marketed in China, accounting for 30.7%. Among 29 innovative drugs marketed in China during the past ten years, the marketing authorization was obtained 5 to 7 years later than the US and EU markets. The third problem is more and more abroad treatment and drug purchase. More and more people prefer to go to foreign countries for medical treatment with the help of intermediary or to purchase drugs via internet or private trans-border commerce, which have already caused many potential risks. The fourth problem is the underdevelopment of generics. For the treatment of serious diseases, we still heavily rely on imported drugs. The domestic generics cannot be clinical interchangeable for innovative drugs. The fifth problem is the unclear efficacy of some domestic drugs. Some of those earlier marketed drugs have a week research basis on drug safety and efficacy. Some of those companies use inferior materials and turn out substandard drugs, take the liberty to change the manufacturing process, and have serious impact on the safety and efficacy of drugs. The reasons for the above-mentioned problems, are not only related to the lack of drug marketing authorization holder system or the lack of liabilities on the drug life-cycle management, but also caused by the lack of intellectual property protection, the lack of clinical resources and the lack of usage policy on innovative drugs. Our reform shall be concentrated on the basic goal, which is to fulfill the public need on drugs. We should stick to the key point on drug safety, efficacy and quality, so as to establish a policy environment to encourage innovation. By these means, the public may be able to get access to affordable, new and good drugs, and the doctors may have more choices when treating the patients.
Thirdly, to deepen reform and to encourage innovation is an urgent need to promote the structural reform of supply-side in pharmaceutical industry and to fulfill the innovation-driven national development strategy. "Innovation" has been placed as the first of the Five Development Concepts. Every since the 18th National Congress of CPC, the policy and system environment on drug innovation has been greatly changed. Many advantages to deepen the review and approval reform and to encourage drug innovation have been achieved. Firstly, there emerges more and more domestic drug innovation. In recent years, more and more scientists who have the background of oversea working experience have returned to China for research or start-up. The amount of domestic new drug application and approval has been increasing annually. Secondly, the reform on review and approval system of drugs and medical devices has been comprehensively implemented. This reform started in 2015, which has improved the review standards, rectified the bad atmosphere on the fake data during the drug clinical trial, and promoted the transparency of review and approval. A group of innovative drugs and medical devices have been approved via fast track. An internationalized drug and medical device review system has been gradually established. The backlog of drug registration application has been basically solved. The Center for Drug Evaluation and the Center for Medical Device Evaluation have been included into the pilot program of government purchase of services, so that the staff of CDE has been expanded from more than 100 five years ago to more than 600 today, and the staff of CMDE has been expanded from less than 100 to 200 more. Thirdly, the consistency evaluation on the quality and efficacy of generics has been smoothly started. The Opinions promulgated by the General Office of the State Council in February 2016 had clarified relevant policies and some local governments have already developed some supporting policies. The industry is quite positive to participate in the consistency evaluation. Fourthly, the pilot program on MAH system has been smoothly implemented. In November 2011, the National People’s Congress has authorized 10 provinces to carry out pilot program on MAH, which has greatly stimulated the enthusiasm of the scientists. Many provinces are now requesting for the implementation of MAH nationwide.
In conclusion, it is very important and practical to deepen reform and to encourage innovation. The Opinions promulgated by the General Office of Central Committee of CPC and the General Office of the State Council, serves as the fundamental document to guide the reform the drug and medical device review and approval system. With the full implementation of the Opinions, we can create a good environment for the innovation and development of pharmaceutical and medical device industry, to stimulate the vitality for drug and medical device innovation, to promote the supply-side structural reform on pharmaceutical and medical device industry, to improve the quality and international competiveness of the industry and to better fulfill the public need for drugs.

2.To comprehensively understand the objectives and missions of deepening reform and encouraging innovation.
Facing the prominent contradictions on drug and medical device innovation, the Opinions raised 36 reform activities in six categories. The content is very rich and every activity is very important. We shall comprehensively implement the Opinions. Hereinafter I would like to emphasize the following ten missions, among which some are related to systematic restructuring, significant policy adjustment and need for capacity building.
Firstly, to expand the resource on clinical trials. Currently, there are 989,000 medical institutes nationwide on different levels, among which there are more than 10,000 Class II or higher class hospitals and 2000 more Class III hospitals. However, there are only 600 more hospitals certified as clinical trial institutes, among which only 100 more can carry out Phase I clinical trial. In order to encourage innovation, we have to solve this bottleneck problem. 1. to increase the clinical resource. The Opinions requires that the certification of clinical trial institutes shall be cancelled. Instead of that, the filing for record system shall be established, the sponsors of clinical trial will recruit the third party to carry out audit and certification, and the trial will be filed in the website of CDE for record. 2. to stimulate the positivity of medical staff. The investigators of clinical trials will enjoy the same level of salary, job promotion and title promotion compared with clinical doctors. 3. to improve the efficiency of ethic review. With the protection of subject safety, health and interest as the preconditions, the system of ethic committee shall be perfected. We shall establish the regional ethic committee and recognize the result of ethic review given by the leading unit of multi-center clinical trials. 4. to ensure the quality of clinical trial. The Opinions clarifies the qualifications of principal investigators, the legal liabilities of sponsors and investigators as well as the responsibilities to carry out regulatory inspection on clinical trials. For all these requirements, CFDA will cooperate with NHFPC to develop detailed implementation guidelines and the local FDA shall collaborate with relevant departments to fully implement them. With the huge population and wide disease spectrum, on the basis of subject interest, it is possible to have innovative medicines firstly marketed in China.
Secondly, to accept the clinical trial data generated abroad. This topic is not only in urgent need to speed up the marketing of drugs in China, but also related to keep pace with global practice. The No.44 Document (GUO FA [2015] 44) clearly encourages the implementation of international multi-center clinical trials, which means that we would accept the clinical trial data generated abroad. In this June, CFDA became the member of International Council on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). One of the key objectives of ICH is to harmonize the standards of drug registration globally, and the standard of clinical trial data is very critical. When solving this problem, we can reduce the duplication and waste on clinical trial resource, speed up the process of clinical trial, reduce the cost and price for the marketing the drug, so as to benefit more patients. Meanwhile, it is a tough and urgent mission for us to train a group of professional inspectors who can speak fluent foreign language and carry out inspection abroad.
Thirdly, to optimize the market approval procedure for drugs and medical devices. In recent two years, we have carried out many reforms on simplifying the market approval procedure for drugs and medical devices. The Opinions summarizes the practical experience on recent reforms and raises the measures to further optimize the market approval procedure. These measures includes: on the basis of thorough pre- communication with the applicants, to change the express approval for clinical trials into implied approval; to establish the centralized dossier acceptance system, and to gradually use international common format so as to achieve electronic acceptance; to establish the Associated Review System for APIs, excipients, and packaging materials with the finished dosage forms, and to stop issuing individual approvals for APIs; to establish a drug review system with technical review as the core and regulatory inspection as the support, so that the inspection, testing and review can be carried out in parallel; to speed up the review for drugs and medical devices in urgent medical need, with breakthrough efficacy or for rare diseases. In the work of drug and medical device review, we will establish the team review system with clinical need as the core, the program manager system, the meeting system with the applicants, the expert advisory panel system for publicly discussion on important disputes, the publication system on review conclusion and reference, etc. All these optimized measures and systems will greatly improve the efficiency of drug and medical device review.
Fourthly, to strengthen the IP protection. Without IP protection, there will be no innovation. For new drug research and development, the companies must bear the huge investment, long-term return period and high risk. Only one of the ten thousands selected compounds can be marketed as the drugs, only 10% of the clinical trials can lead to the successful market approval, even for generics, the first-round approval rate of USFDA is only 10%. There are five measures related to IP in the Opinions. 1. Data Protection. This data protection system was a commitment made by Chinese government when entering WTO, which provided a certain period of protection on the safety, efficacy and other data generated in the clinical trials of new drugs or improved new drugs. During this period of time, other applicants cannot submit the application based on these data and CFDA will not rely on such data to approve other drugs. 2. to explore the establishment of patent linkage system. When submitting the generic applications, the applicants shall publicly announce the related patent status. During the drug review, the patent disputes shall be solved by judicial system. By these means, the legal risk for marketing generics will be lowered and the patent holders' interest can be better protected. 3. to carry out pilot program on drug patent restoration system. As the drug can only be marketed after clinical trials and review and approval, the market exclusivity period of the patent holders will be shortened. In 1984, USA promulgated the Act to provide patent restoration on the time for clinical trials and review and approval. Japan and EU also introduced this system in 1988 and 1992 respectively. The precondition to establish this system was to change the clinical trial for generics into bioequivalence study, which greatly lowered the cost of generics, so as to achieve a balance between the innovative drugs and generics. We shall develop a plan as soon as possible and carry out pilot program after being authorized by the National People's Congress. 4. to establish the priority review system for compulsory licensed drugs, so as to meet the special need when facing severe public health threat. 5. to establish the List of Marketed Drugs. This is the so-called Orange Book System in foreign countries. Any innovative drugs or improved new drugs must pass double-blinded, randomized and large-scale clinical trials to verify its safety, efficacy and quality in order to get market approval, and will be given the status of reference preparations. The generics that proved to be consistent with the quality and efficacy of innovative drugs will also be added into the list. The doctors and pharmacists can use this list for reference. With the above-mentioned measures, we can form a “combination blow”for IP protection, so as to not only protect legal rights of the patent holders and encourage the vitality of innovation, but also to encourage, guide and regulate generics.
Fifthly, to speed up the process of quality and efficacy consistency evaluation. The consistency evaluation for oral preparations has already been thoroughly implemented. On August 25, CFDA issued the Notice on Relevant Items on Quality and Efficacy Consistency evaluation for Generics, further clarified relevant policy requirements and procedures. The local FDA shall fully implement this Notice. The reevaluation of injections is also one key component for consistency evaluation. The Opinions raises the task to finish the reevaluation of injections in 5 to 10 years. Injections, especially intravenous injections are high-risk dosage forms, and we shall strictly regulate these products. The Opinions sets forth strict limitation on the review and approval of injections and requires the MAH holders to carry out research on the content, mechanism and clinical efficacy, and to evaluate the safety, efficacy and quality control. CFDA will clarify the method and timetable for injection reevaluation as soon as possible. The local FDA shall organize relevant enterprises to carry out research as earlier as possible. The earlier you start, the more positive you may be.
Sixthly, to establish the file for drugs and medical devices. This is a fundamental task for drug regulation and is also a mission set for by the Opinions. The Article 10 of Drug Administration Law specified that "a drug shall be produced in conformity with the National Drug Standard and with the production process approved by the drug regulatory department under the State Council, and the production records shall be complete and accurate. When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the matter for examination and approval to the original approval authority." Last August, CFDA publicized the drug manufacturing process verification plan for comments. This mission will start from the register of drug manufacturing process. CDE and Information Center of CFDA have primarily established the platform for process register and CFDA will soon specifically deploy this mission. All drug manufacturers must fill in the APIs, excipients, origin of APIs and excipients, manufacturing process, process indicators, insert sheet, etc. into this platform. Those who fail to register will be publicized and then enter the market withdraw procedure. We will also establish similar system for medical devices. Any activity violating Article 10 of Drug Administration Law will be severely punished.
Seventhly, to place the legal liabilities on MAH. The holder of drug or medical device approval documents is actually the holder of market authorization. He benefits from the market authorization and also is liable for the life cycle of the drug or medical device. Those who get the benefit shall also be liable. The MAH can carry out contract manufacturing or contract/authorized distribution, yet also remain his liability. This is the common practice of market economy and society governed by law. The Opinions specified that MAH must be fully liable on pre-clinical study, clinical trial, manufacturing, distribution, ADR reporting, etc.; must ensure the authenticity, completeness, traceability of the research and clinical trial dossiers; must ensure that the actual manufacturing process is in conformity with the approved process and the compliance of entire manufacturing process; must ensure the distributed lots of drugs and medical devices are consistent with the quality of the submitted samples; must carry out continuous research on marketed drugs and medical devices , report the ADE or AE, evaluate the risk and raise the measures for improvement. The local FDA who participated in the MAH pilot program shall summarize the experience as soon as possible and we shall try to fully implement this reform nationwide as soon as possible.
The Opinions emphasized that the direct ADR/AE reporting system by MAH shall be established. This is one key measure to place legal liabilities, to perfect the research on drug quality and to ensure drug safety for the public.
Medical Representatives are staff assigned by MAH, and take the important responsibilities on academic promotion and knowledge introduction to the doctors. The Opinions set forth strict requirements on this matter.
Eighthly, to clarify the regulatory responsibilities between the central and local government. To promote the reform on review and approval system, to cancel the approval for clinical trial institutes, to optimize the approval procedure for clinical trials, to accept clinical trial data generated abroad, to implement the MAH system, etc., have created higher requirements for our regulatory works, especially for on-site inspection on drug manufacturers and researchers. The Opinions clarified the division of responsibilities among central and different level local governments. CFDA will be responsible to inspect the implementation of Drug GLP, Drug GCP and Medical Device GCP during the process of R&D ; the Provincial FDA or above will be responsible for the inspection on the GMP during the process of manufacturing; the Municipal and County FDA will be responsible for the GSP during the process of distribution. Where problems are identified during the inspection, the relevant departments will handle the case and carry out risk control measures; where a crime is constituted, the case will be transferred to the judicial departments and criminal liabilities shall be investigated. The key issue is to ensure the consistency for law enforcement, so that we can organize the entire drug regulatory system to fulfill different responsibilities at different stages.
Ninthly, to strengthen the institutional guarantee and capacity building. Our goal is to establish a modernized review and inspection system for drugs and medical devices, to shorten the gap between China and developed countries in 5 to 10 years and to solve the problem of drug safety for Chinese people.
The life-cycle liabilities of MAH shall be placed as the core, so when revising the Drug Administration Law, the experience and practice generated during the period of reform can finally be settled in the form of laws and regulations.
We shall strengthen the capacity building. Based on the requirements on government purchase service and the efficient review service, we shall strengthen the capacity building for drug and medical device review, so as to meet the need of innovation and development of drugs and medical devices. We shall also speed up the process to establish the professional inspector team, so as to fulfill our responsibilities to supervise the whole-process including research, clinical trial, manufacturing, and distribution of drugs and medical devices, to ensure the authenticity, completeness, integrity and traceability of data, and to timely handle illegal activities and remove the potential risks.
Tenthly, to feasibly avoid the conflict of interests. The Article 29 of the Opinions specified that any staff responsible for dossier acceptance, review and approval, regulatory inspection, etc. shall be obliged for the confidentiality of know-how and trial data. We shall perfect the management system on registration dossiers, so as to ensure the traceability of any activity such as check or copy. It is our responsibility to ensure public health. The goal of the reform is to create a fair, just, public and transparent regulatory environment.
In order to avoid conflict of interests, we shall keep confidentiality for the enterprises. When establishing the file of drug and medical device, reviewing and approving drugs and medical devices, carrying out on-site inspection on drug manufacturers, we will get access to the know-how and commercial secrets of the enterprises. It will damage the right holders’ interest if we release the confidential information.
In order to avoid conflict of interests, we shall not have any interest relationship with the enterprises. We shall strictly obey the spirit and anticorruption disciplines set forth by the Eight Rules against Extravagance, formalism and Bureaucracy. We shall not make any investment on the regulated enterprises, shall not own any stock of the regulated enterprises, and shall not seek for personal gain from the review, inspection or testing. Any civil servant cannot become the spokesperson of the enterprise interests.
In order to avoid conflict of interests, we shall also keep the working confidentiality. All staff carrying out review, inspection, testing or law enforcement, shall not release any drug review information in private, shall not release any regulatory information which are still under discussion and have not formed any final decision, and shall not make a profit by using internal information.
Without conflict of interests and releasing confidential information, we can keep our team away from corruption, can gain the trust from the enterprises and can ensure the authority of our regulation. On one hand, we shall set forth internal disciplines, and on the other hand, we call for the external supervision from the enterprises, local regulatory agencies and discipline inspection committee. When the local FDA carries out on-site inspection, we shall also pay attention to the conflict of interests. We can never damage public health and interests for the sake of development, employment or financial income. This is a discipline and is also a test for everyone.
3.To concretely implement every reform task.
The promulgation of the Opinions provided us with an unprecedented and historic development opportunity for the structural adjustment and technical innovation for drug and medical device industry. The FDA at all levels shall unify thoughts and regard the implementation of the Opinions as the important political mission. We shall stick to the plan on promoting reform and safeguarding public interest, shall handle the contradictions and problems occurred during the reform and shall ensure the achievement of the reform objectives.
Firstly, to make great effort on learning and training. The Opinions specified series of significant concepts on drug and medical device regulation, pointed out the basic direction for reforming review and approval system, clarified the key policies to encourage innovation, and raised the important mission on strengthening capacity building. The Opinions serve as the basic creed of the regulatory reform on drug and medical devices, the basic guidance to carry out regulatory activities and the basic ideological basis for revising the Drug Administration Law. The basic spirits of the Opinions are also applicable on food safety regulation. The FDA at all levels shall make great effort to learning and training of the documents. Especially for those staff related to drug and medical device regulation, a focused training shall be organized so as to help them to have a better understanding on the spirits and content of this document. This is the precondition of full implementation.
Secondly, to strengthen the organization and leadership. To deepen the reform on review and approval system and to encourage the drug and medical device innovation, are key tasks of comprehensive and deepened reform set forth by the central committee of CPC and the State Council. The FDA at all levels shall attach great importance on the tasks and support the reform as the key contents for the establishment of innovative China and the promotion of high-tech industry development. We shall perfect the food and drug regulatory system, strengthen the coordination and harmonization, set for the detailed implementation plans, complete the working mechanism and to ensure the thorough implementation of all reform tasks. The FDA at all levels shall positively report to the leader of local CPC committee and People's government, serve as the assistants and advisors and timely report any significant matter during the implementation of this document.
Thirdly, to strengthen the coordination and cooperation. The Opinions emphasized that the Inter-Ministerial Meeting Mechanism on Reforming Drug and Medical Device Review and Approval System shall be fully used so as to timely solve the contradictions and problems during the process of reform. The Opinions set forth clear working requirements to different ministries in the government. Relevant departments of CFDA, CDE, CMDE and CFDI have already drafted a set of associated rules, requirements, guidelines and working procedures and will soon issue them. The provincial FDA shall strengthen the cooperation with other departments and fully implement these documents. During the process of reform, we shall also pay attention to the publicity guidance.
Fourthly, to complete the associated policies. The Article 21 of the Opinions set forth clear requirements on supporting the clinical use of new drugs, the reimbursement of medical insurance and centralized purchasing for medical institutes. The local government shall complete relevant policies to encourage the research, manufacturing and use of drugs and medical devices, so as to guide the enterprises to make additional investment on research and development, to set forth MAH's liabilities of ADR reporting, and to strengthen the research on the quality of marketed products. We shall continue to implement the policies on the consistency evaluation of generic quality and efficacy.
Fifthly, to enhance the effort on regulatory inspection. Currently, the drug safety situation in China is quite stable and good; however, there are still some potential risks on safety and quality. The problems of fake data or illegal operation occur occasionally, the repeated emergence of activities such as the use of inferior materials, adulteration, counterfeiting, illegal distribution of prescription drugs, resale of recollected drugs remain as big problems, so the situation is still complicated and serious. We shall pay attention to both the reform and regulation. We shall strengthen the on-site inspection and quality sampling and testing on those critical problems, such as multicomponent biopharmaceuticals, TCM extracts and those low price tender drugs, so as to eliminate the potential risks and to ensure the drug safety for the public.
My colleagues, the curtain of deepening the review and approval reform and encouraging drug and medical device innovation has now been opened. Let us closely united under the leadership of the CPC Central Committee with General Secretary Xi Jinping as the core, firmly establish the sense of politic, the sense of overall situation, the sense of core and the sense of Par consciousness, and carefully implement the requirements on most rigorous standards, most strict regulation, most severe punishment and most serious accountability, so as to speed up the marketing of good and new drugs, to meet with the public need for drugs, to make more contribution on the establishment of innovative China and the achievement of Two Centenary Goals and to welcome the success of the 19th CPC National Congress with full spirits and excellent performance.


HOME | ABOUT CFDA | WHAT'S NEW | LAWS AND REGULATIONS | REGULATORY GUIDE | DATA SEARCH
| SITE MAP |
© CFDA
Constructed and Maintained by the Information Center of CFDA