From May 31st to June 1st, 2017, the first meeting of 2017 of the International Technical Coordination Committee for the Registration of Pharmaceuticals for Human Use (ICH) was held in Montreal, Canada.

　　The meeting passed the application of the State Food and Drug Administration of China, and the General Administration became a full member of the International Technical Coordination Committee for the Registration of Human Drugs.

　　▍Why join ICH? What is the significance?

　　Since the establishment of ICH, it has gradually developed into the core international technical rule-making mechanism in the field of drug registration. Drug regulatory authorities in the United States, Europe, and Japan have conducted reviews in accordance with ICH technical guidelines, and other drug regulatory agencies in the world have also accepted in whole or in part The review is carried out based on the ICH technical guidelines.

　　Joining ICH is a major measure taken by the State Administration to actively implement the "most rigorous standards" of the "four most stringent" requirements, and it is also an important manifestation of the international community's recognition and support for my country's ongoing reform of drug review and approval.

　　Joining the ICH is conducive for the General Administration to learn from the latest international regulatory scientific achievements and absorb advanced international regulatory concepts, thereby enhancing my country's drug regulatory capabilities and levels, gradually participating in and guiding the formulation of international rules, and strengthening the right to speak in international organizations;

　　Joining ICH is conducive to encouraging international innovative pharmaceutical companies to incorporate the Chinese market into their global drug development strategies, promoting international innovative drugs to enter China, and meeting clinical drug needs;

　　Joining ICH will help promote the gradual integration of China's drug R&D and registration with international regulations, thereby comprehensively enhancing the innovation capabilities and international competitiveness of Chinese pharmaceutical companies.

　　▍Does joining ICH mean international recognition? What impact will this have on my country's pharmaceutical industry?

　　The United States, the European Union, and Japan have mature and complete drug regulatory systems and the pharmaceutical industry. The ICH led by them has long coordinated technical specifications on drug quality, safety and effectiveness on a global scale, and promoted the rationalization and rationalization of technical requirements for drug registration. Unification has become the highest rule-making mechanism for international drug registration technology. These standards are universally applied by developed countries and are also widely accepted by developing countries including China. Some drug regulatory underdeveloped countries even directly accept or recognize the review results of ICH member states.

　　The accession of the State Food and Drug Administration of China to ICH marks the international community’s recognition of the Chinese government’s drug review and approval reform and China’s pharmaceutical industry, and it means that the international community is willing to accept Chinese regulatory agencies, pharmaceutical industries, and research institutions to join the highest international rules and standards. The formulation process. This has a very positive and positive impact on our regulatory system and the international recognition of the pharmaceutical industry.

　　But at the same time, we must also be soberly aware that after joining ICH, we need to further carry out arduous and long-term work. In this process, not only the government will need to carry out a lot of work in the transformation and implementation of technical guidelines, but also the industry, The academic community has made unremitting efforts to implement these guidelines.

　　▍Currently, what is the current status of the application of ICH technical guidelines in drug registration in my country? How will it proceed next?

　　ICH has established an international platform for regulatory agencies and industry to discuss scientific and technical issues of drug registration. The technical guidelines issued by ICH have become the internationally advanced technical requirements for general drug registration. Currently, ICH has issued 76 technical guidelines.

　　We have been paying attention to and studying ICH technical guidelines. In recent years, many technical guidelines formulated and issued by the General Administration have referred to ICH related guidelines to varying degrees in the drafting process, and are very close to ICH technical guidelines in terms of content and technical requirements.

　　On August 5, 2016, the Center for Drug Evaluation of the General Administration issued the "Notice on Reference and Use of WHO, ICH and other Drug R&D Technical Guidelines", clarifying that drug R&D institutions can refer to the World Health Organization (WHO) and International Human Drug Registration Technical Requirements International Various technical guidelines issued by the Coordination Council (ICH), the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to carry out drug research and development.

　　In the next step, the General Administration will actively participate in ICH-related work and make more Chinese voices internationally. At the same time, it will further promote the domestic transformation and implementation of ICH technical guidelines.

　　▍After China officially becomes a member of ICH, what opportunities and challenges will Chinese companies have on the road to internationalization of drug R&D and drug registration applications?

　　ICH’s main task is to formulate international technical requirements for the registration of human drugs. After China’s accession to ICH, it can participate in the formulation of the ICH guidelines. At the same time, it also needs to gradually implement the ICH guidelines in China, which means that the technical requirements for drug registration in China are in line with international standards. The road has been fully opened, and drug R&D and registration have entered the era of globalization.

　　To achieve the coordination and consistency of the technical requirements for drug registration, for pharmaceutical companies that carry out international registration, they will be able to declare to the regulatory agencies of multiple countries or regions according to the same technical requirements, which greatly saves the cost of research and development and registration. This is not only conducive to the entry of new drugs produced abroad into the Chinese market, but also conducive to the internationalization of medicines produced in China, which promotes more and more Chinese companies to join the ranks of international registration.

　　Through the implementation of the ICH guidelines, Chinese pharmaceutical companies will also deepen their understanding of the international technical requirements for drug registration, reduce detours in R&D work, and increase the success rate of international registration.

　　But at the same time, joining ICH means that China's pharmaceutical industry will be placed in the global structure to participate in competition. my country's pharmaceutical industry as a whole still has a gap with developed countries such as Europe, the United States, and Japan, especially in terms of innovative research and development capabilities. For domestic enterprises, they must seize the opportunity, actively research and understand the ICH guidelines, and integrate these technical requirements into all aspects of enterprise product development, registration and production, and truly transform them into the rules for improving product safety and quality, and improve the core Competitiveness.

　　ICH is a non-governmental international organization that the regulatory authorities and the pharmaceutical industry participate in together. It is a process where the regulatory authorities and the industry jointly discuss and exchange, promote mutual development, and finally reach a consensus. As a regulatory agency, our bureau also needs to further enhance its regulatory capabilities, improve service levels, strengthen policy guidance, and work with the industry to maintain and promote public health and improve the availability of medications.

　　▍After China officially becomes a member of ICH, how will the speed of approval of global innovative drugs in China increase?

　　In August 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44), marking the full launch of the reform of the review and approval system for medical devices. Over the next year or so, our bureau has taken a series of measures to improve drug approval standards, encourage drug research and development innovation, improve review and approval efficiency, and standardize clinical trial behavior, and actively and steadily promote reforms.

　　Among them, in order to speed up the listing of new drugs with clinical value and clinically urgently needed generic drugs, and meet the public demand for drugs, a priority review and approval policy has been implemented, and priority review is implemented for drug registration applications in 3 categories and 17 situations with obvious clinical value. Evaluation and approval. The priority review and approval policy has achieved good results. In 2016, a number of drugs expected by the public, such as the anti-tumor drugs Regorafenib tablets, pezopanib tablets, and gefitinib tablets, entered the market through priority review and approval.

　　China's pharmaceutical product market has huge capacity and rapid growth. The dividends of the reform policy of the drug review and approval system are beginning to appear, and the attraction to pharmaceutical companies is self-evident. After China joins ICH, the differences with international technical requirements will continue to shrink or even disappear. The path for companies to include China in the global development plan in the development of innovative drugs will be smoother, and it will surely further improve the development and registration of innovative drugs in China. It can be expected that in the near future, more innovative drugs will be launched in China to better meet the public's drug demand.