SINO-EUROPE SYMPOSIUM ON TRADITIONAL CHINESE MEDICINE & HERBAL MEDICINE-MARKET OVERVIEW ®ULATION POLICY

Opening Ceremony

He Li (Vice Secretary-general of Chinese Pharmaceutical Association): Just now, I introduced the main guests.Now I will introduce the main keynote speakers and the host. The first one is from Germany Federal Medicine and Medical Devices. Among the delegates, there is also a very important person, Ms. Zhu Lihong, Senior vice president of DIA China. She is also one of the main planners of the conference; representative of Chinese enterprises includes Tasly Holding Group.

After careful planning by the organizers of Chinese Pharmaceutical Association and Medicine Information Association, as well as in-depth exchange with experts in the regulatory bodies of the two sides, industries, and academic circles, we listed topics of mutual interests at this meeting, and sent them to the speakers before the meeting.I hope that the speakers can focus on these issues of mutual interests and can do more introductions. In addition, we have set up three discussion sessions. Today's discussion session will be half an hour. And there will be sufficient time for in-depth discussions tomorrow afternoon, when the participants in the discussion will be more, and the main representative will have time to participate in the discussion. We look forward to the fruitful results of these two days meetings, which will bring us deep thinking.

Address in the Opening Ceremony

Sun Xianze (孫咸澤)

(President of the Council of Chinese Pharmaceutical Association)

Dear Mr. Chairman, distinguished guests, experts,and representatives, Good morning. Today, Chinese Pharmaceutical Association and Drug Information Association holds the Sino-Europe Symposium on traditional drugs, inviting representatives of drug regulatory bodies, academic institutions, production enterprises, both from China and the European Union(EU), having in-depth discussion on law and regulations,on traditional medicine, experiences on review and approval, drug research and development, quality control, problems and challenges, discussing the future development and cooperation, and jointly promoting the well-being of mankind. Hereby, on behalf of Chinese Pharmaceutical Association, I would like to extend my warm congratulations to the successful convening of this seminar. I would like to express my heartfelt gratitude to all the guests, delegates, and the forum partner,Drug Information Association. Fellow representatives,traditional drugs are the common wealth of all mankind and play an irreplaceable role in protecting public health.Traditional medicine is not only a unique health resource,but also a huge economic resource with potential, a scientific and technological resource with original advantages, excellent cultural resource and important ecological resources.

President Xi Jinping points out that Chinese medicine is a gem of ancient Chinese science and the key to opening the treasure house of Chinese civilization.As an outstanding representative of the Chinese nation,Chinese medicine is gradually formed in the struggle by the Chinese people in thousands of years production and life practices. And it continues to enrich itself and develop. Chinese medicine is an important means and unique resource for the Chinese nation to prevent and cure diseases and prolong life, which is not only a treasure of the Chinese nation, but also a contribution of China to the health of mankind. Everyone knows that in 2015, professor Tu Youyou, a researcher in China Academy of Chinese Medical Sciences, discovered artemisinin in Chinese medicine, which significantly reduced the mortality rate of malaria patients, and thus she won the Nobel Prize in Physiology and Medicine.That was her outstanding contributions to the global health. This year also coincides with the 70thanniversary of the founding of the People's Republic of China. In the past 70 years, especially in the 40 years after reform and opening up, China's economic development has grown by leaps and bounds, and it has become the world's second largest economy and the largest manufacturing country.The development of China's pharmaceutical industry in the past 40 years is also a microcosm. The total value of the national pharmaceutical industry has reached from 7.3 billion yuan per year before the reform and opening up, to 3 trillion yuan per year. That is to say it has increased by 410 times in 40 years. Differently, the reform of China's pharmaceutical industry is also deepening, with opening up to the outside world accelerating, the regulatory system constantly improving, and the vitality of pharmaceutical companies continues increasing. Everyone knows that we have reformed the drug review and approval system since 2015. In August 2015, the State Council specially issued the Suggestions on the Reform of the Drug Medical Device Review and Approval System. In October 2017,the General Offices of the CPC Central Committee and State Council issued the Suggestions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices. In April 2017, the State Council also issued the Suggestions on Reforming and Improving the Policy of Supply and Usage of Generic Drugs. And National Medical Product Administration was established in his round of central government reforms on drug regulatory system. By the above-mentioned series of reform measures, the reform of China's drug regulatory, review and approval system has made a major breakthrough.

First, the pace of review and approval has been accelerated. We can now do the drug review on time without backlog. Basically, an on-time review was achieved.

Second, the consistent evaluation of the quality and efficacy of generic medicines was solidly promoted.I have noticed that the EU, the United Kingdom and the United States and Japan are doing this work. And we have made breakthrough in 3 years. By the end of 2018,19 batches of 參考文獻 preparations have been released,reaching 1,151 specifications, and 126 product-standard generic medicines have passed the consistency evaluation.China-listed drug catalogue was released.

Third, the pilot of the medicine listing permit holder system has made breakthroughs, in 10 provinces and cities,laying a solid foundation for the full implementation of the medicine listing permit holder system.

Fourth, National Medical Products Administration officially became a member of IRCH in 2017 and joined its management committee last year. That progress will greatly promote the integration of China's medicines registration with the international community, and make a big step for the import registration of the original medicines and the participation of local original medicines in international registration, promoting the development of China's pharmaceutical industry into the fast lane.

The Chinese government attaches great importance to and strongly supports the inheritance and development of Chinese medicines, adhering to the integration of Chinese and Western medicines as an important part of health career. The development of Chinese medicines has been listed in the national development strategy. In 2016,the State Council issued the Outline of the Strategic Plan for the Development of Chinese Medicine from 2016 to 2030, which made deployment for the development of Chinese medicine in the next 15 years. In July 2017,

Law of the People's Republic of China on Chinese Medicine began to implement, providing a sound policy environment and legal guarantee for the development of Chinese medicine. The Chinese government has established an inter-ministerial joint conference system for Chinese medicine in the State Council to coordinate and promote the development of Chinese medicine from a higher level.

Of course, we also see that due to differences in culture, history and religious background, the scientific connotations of the traditional medicine theory systems of various countries have not been widely accepted and understood by modern society, and there is insufficient communication between traditional medicines and modern medicines. The inheritance and innovation of traditional medicines is also a common challenge faced by our countries.

President Xi Jinping pointed out that it is necessary to deeply explore the essence of the treasure house of traditional Chinese medicine, to promote the integration of production, education and research, to promote the industrialization and modernization of Chinese medicine,and to let Chinese medicine go global. Efforts should be made to achieve creative transformation and innovative development of TCM health and wellness culture,which pointed out the direction for the development and innovation of traditional Chinese medicine. The innovation of traditional Chinese medicine should be based on inheritance, driven by innovation, giving full play to the leading role of traditional Chinese medicine in treating diseases, and in the synergistic function in the treatment of major diseases, in the core function by disease rehabilitation.

The potential and vitality of Chinese medicine resources should be inspired and released, promoting modernization and internationalization of traditional Chinese medicine, and improving the regulatory policies,management systems, evaluation and standard systems that are consistent with the characteristics of traditional Chinese medicine, and better serving the construction of healthy China and economic and social development.

We have noted that EU countries have leading advantages in life sciences, biotechnology, and systems biology and also have rich experience in the supervision and application of herbal medicine. By this meeting, we hope that regulatory bodies, academic institutions and the industries can learn more about supervisory methods of each other's traditional drugs, and development level,creating a platform for dialogue between China and the West, expanding cooperation in traditional medicine.

Second, it is hoped that by the complementary advantages, the current multidisciplinary methods and technology will be applied to research and promote the modern Chinese medicine products that meet the needs of the international market. Mechanism of traditional Chinese medicine therapy could be more clearly elaborated on, so that Chinese medicines can go to the international market.

Third, it is hope that by cooperation with EU countries in traditional and new drug research,development and registration, international standards and norms of traditional drugs could be developed, which will be recognized and accepted by the international community. And traditional medicine industry will continue to expand.

Fourth, we hope that we could build international communication system of traditional drugs in a coordinated manner, with multi-channel, multi-level and multi-modal.

Dear delegates, distinguished guests, China Pharmaceutical Association was established in 1907,whch is one of the earliest academic groups established in China in modern times. For more than 110 years,Chinese Pharmaceutical Association has been committed to the prosperity and development of China's pharmaceutical science and technology. In the field of Chinese medicines, Chinese Pharmaceutical Association established 5 specialty committees of traditional Chinese medicines and natural medicines, including those of traditional Chinese medicines and natural resources, traditional Chinese medicine resources,clinical pharmacology, traditional Chinese medicine clinical evaluation, rational Chinese medicine oncology drugs and clinical evaluation. China Pharmaceutical Association will give full play to its advantages of platform and resources, jointly promoting international exchanges and cooperation in the field of traditional medicine with the countries in the world, continuously strengthening the combination of modern science and traditional Chinese medicine such as life sciences and biotechnology etc., utilizing international scientific and technological resources to strengthen the inheritance and innovation of traditional medicines, accelerating the traditional medicines going to the world, letting Chinese medicines and other traditional medicines play a greater role in promoting health, and making great contributions to preventing human beings from facing major diseases and improving human health. Finally, I wish this symposium a complete success, thank you all.