The blue book of pharmaceutical industry - "big data of China's pharmaceutical research and development in 40 years of reform and opening up" is the first to read!

During the Spring Festival, we launched the "WeChat medical history", "China's pharmaceutical research and development, and leisure time to read 40 years" reading activities (the specific time and content are shown below) The official account of the 40 years' reform and opening up of China's pharmaceutical research and development data has been well received by yaozh008 At the request of fans, we gathered all the contents that were released during the Spring Festival to facilitate you to take a look at the whole picture If you want to see the students, please pay attention to the official account of the drug net public (yaozh008) and reply to the blue book The following is the preface: In the past 40 years of reform and opening up, China's society and economy have undergone tremendous changes, and the development of the pharmaceutical industry has changed with each passing day: the growth rate of the industry has exceeded the growth rate of GDP for a long time, saying goodbye to the era of lack of medicine; the research and development of drugs has entered the era of strengthening innovation and pursuing high-quality drugs; during this period, China has transformed into a veritable pharmaceutical country, contributing a lot to healthy China Power: the advent of innovative drugs such as artemisinin has benefited hundreds of millions of malaria patients around the world However, compared with the United States, Europe, Japan and other pharmaceutical powers, China's pharmaceutical industry still has a large gap Although China's pharmaceutical market capacity ranks the second in the world, the global pharmaceutical industry is mainly the world of the United States and Europe Among the global pharmaceutical giants, it is difficult to find Chinese enterprises The distance between them is worth thinking about The pharmaceutical industry is a global industry No pharmaceutical giant only sells drugs in its own country, and no heavyweight drugs only sell in its own country Internationalization is the only way to develop a strong pharmaceutical country, while China's pharmaceutical industry has just started The pharmaceutical industry is a R & D driven industry, and also the industry with the highest proportion of R & D investment The R & D cost of global pharmaceutical giants is up to 17%, far higher than other industries A country with strong pharmaceutical R & D is a strong pharmaceutical industry, and an enterprise with strong R & D is a strong pharmaceutical strength and competitiveness China's pharmaceutical industry has changed from drug sales to R & D driven, and the market value of Hengrui pharmaceutical, a leading pharmaceutical R & D enterprise, has reached nearly 300 billion yuan In the pharmaceutical industry, R & D has won the world Moreover, according to the latest concept of "quality comes from design" (QBD), safe, effective and quality controlled good drugs are neither detected nor obtained only by production control The key is to consider quality assurance from the design (R & D) stage, which is the root Therefore, the book "big data of China's pharmaceutical R & D in the past 40 years of reform and opening up" is devoted to the in-depth discussion of China's pharmaceutical industry from the perspective of R & D and taking data as the starting point, exploring the ups and downs of the past 40 years in the field of pharmaceutical R & D, the experience and lessons of the past 40 years, the progress of the past 40 years and the brilliant achievements of the past 40 years Drug is a kind of special commodity, which needs registration and approval before it can be listed All the efforts of enterprises in the process of registration and approval are drug research and development Therefore, the national registration and approval policies are the baton to guide drug research and development In the 40 years of reform and opening up, we try to sort out the change process of drug R & D supervision, and fully show the development trend of drug R & D through the impact of data perspective policies on R & D Looking back on the 40 years of reform and opening up, the medical policy has gone through a long and tortuous process from imperfect to relatively perfect What we have achieved today is precisely based on the accumulation of history As Xu Jinghe, deputy director of the State Food and drug administration, said, "problems are the voice of the times and the driving force of change If we study the history of world drug regulation, we will find that it is a history of problems The history of problems is the history of change, the history of growth and the history of progress Before the reform and opening up, the country didn't realize the particularity of drugs Although there were relevant systems, they were not implemented In 1963, the Ministry of health, the Ministry of chemical industry and the Ministry of Commerce jointly issued several provisions on Drug Administration (Draft), which is the first comprehensive regulation on Drug Administration in China and establishes the management principles of new drug products; in 1965, the Ministry of health and the Ministry of chemical industry jointly issued the Interim Measures for the management of new drug products (Draft), which is the first drug new product management office implemented in China Law It can be seen from the issuing units of the above policies (Ministry of health, Ministry of chemical industry, Ministry of Commerce and national science and Technology Commission) that the management of drugs in China has not yet established a system and is still in the stage of multi management Not only that, these drafts have not even been implemented yet, and China has entered the stage of Cultural Revolution During this period, "new drugs" and "new products" came out one by one, without clinical trials or approval of drug administration departments... in 1978, the reform and opening up, the pharmaceutical industry ushered in a new development opportunity, towards a long way of scientific supervision This year, the State Council approved and transmitted the regulations on Drug Administration (for Trial Implementation) issued by the Ministry of health, which is the first truly implemented drug administration method in China In 1979, the Ministry of health and the State Administration of Medicine jointly issued the measures for the administration of new drugs (for Trial Implementation) in accordance with the relevant provisions of the regulations on the administration of drug administration, with a total of 16 contents, which comprehensively stipulated the classification, scientific research, clinical, identification, approval, production and management of new drugs New drug research and development in China began to enter a new era (but this document has more serious drug approval rights The local government still has the right to approve new drugs The drug administration law of the people's Republic of China came into force on July 1, 1985 For the first time, China has established the drug administration system in the form of legislation Before that, the rules and regulations of the State Council or government departments were adopted, which is also the concrete embodiment of our country's legal society in the field of medicine In 1985, the Ministry of health also promulgated the measures for examination and approval of new drugs in accordance with the drug administration law and implemented them simultaneously Since then, the approval management of new drugs has entered the stage of legalization In 1999, the State Drug Administration was established, and the authority of drug approval and registration was centralized from the local to the State Drug Administration In 2002, the measures for the administration of drug registration was issued, and unified standards were implemented nationwide Drug supervision has become a relatively independent and perfect institution and system, opened a new chapter in drug research and development, and stimulated the vitality of enterprises But at the same time, due to the immature understanding of drug registration and the loose supervision of registration, the enthusiasm of drug registration of national pharmaceutical enterprises is high According to statistics, in 2005 and 2006, the drug audit center undertook more than 20000 drug registration applications, and in 2005, the number of chemical drugs and traditional Chinese medicine applications exceeded 10000 It was not until the verification of drug registration in 2007 that the verification of the authenticity of drug declaration materials was strengthened, and the 2007 version of "measures for the administration of drug registration" was issued to strengthen the supervision Only in this way, the fanatical "enthusiasm for registration" of enterprises was curbed and the steady development stage was entered However, the nonstandard and untrue drug research and development has not been really solved At the same time, the backlog of drug review and approval is serious, which affects the enthusiasm of drug innovation It was not until July 22, 2015, when the clinical trial verification, the State Council issued the opinions on reforming the review and approval system of pharmaceutical medical devices, and launched the consistency evaluation of generic drugs that the curtain of the new pharmaceutical policy was opened With China's accession to the ICH in 2018, China's pharmaceutical research and development began to fully integrate with the international community The progress of the new policy in the research and development field in the past three years is fundamental What has changed is not only the quality of drugs itself, but also the concept and concept of pharmaceutical people What has been removed is the accumulated criticism Looking back on history is not to remember the past, but to see more clearly the footprints of history, the trend of development, to answer the current doubts, and to make clear the direction shown This book systematically reviews the changes of drug R & D regulatory agencies and policies in the past 40 years through the first articles of Association - drug regulatory chapter; reform is inseparable from opening up; the second chapter is dedicated to how to open up the door of our country in the field of medicine, introduce and go abroad; the third, fourth and fifth chapters are respectively combed for chemical drugs, traditional Chinese medicine and biological drugs, with strong data, rich charts and direct It shows the R & D process of these three kinds of drugs in the past 40 years; the sixth chapter is dedicated to the core work of drug R & D clinical trials; the seventh chapter analyzes the overall situation of drug R & D in China in recent years, combs the ranking of R & D strength of enterprises, sets an example and encourages the backward Finally, the appendix "China's pharmaceutical R & D milestones" summarizes the relevant policies and events of pharmaceutical R & D annually for readers to consult At the same time, we have combed the drug registration laws and regulations over the years into a "list of Chinese drug registration laws and regulations over the years" Readers can go through time and space to understand the historical changes Of course, the reform and development in the field of pharmaceutical research and development is still on the way, and pharmaceutical research and development is only a part of the pharmaceutical industry and the whole social economy, which cannot be separated from the development of the overall environment However, I hope that the field of pharmaceutical research and development is not only in it, but also to lead the development of China's pharmaceutical industry and become a model of China's innovative development, so that China can realize the transformation from a big country of generic drugs to a big country of innovative drugs as soon as possible, and from a big country of pharmaceuticals to a powerful country of pharmaceuticals Maybe we don't have the absolute authority and integrity to master the information, maybe our opinions are biased, but fortunately we have the love and passion for the pharmaceutical industry, the rich data resources of pharmaceutical intelligence network, and the wisdom and sweat of all authors At the same time, with the strong support of many experts and leaders, this book is able to meet the readers, so that readers can fully understand the 40 years of zigzag development process and data of pharmaceutical R & D, and better understand the significance and direction of pharmaceutical R & D reform Here, thank you for the rich data resources provided by yaozhi.com, thank you for your hard work, thank you for the support of experts and leaders! Due to the time span of 40 years, limited by the resources obtained, as well as the hasty compilation time, there may be many errors and deficiencies Please understand and tolerate more, and welcome your criticism and correction in the message area at the end of the article This paper is excerpted from the book "big data of China's pharmaceutical research and development in the past 40 years of reform and opening up", which was initiated and compiled by yaozhi.com and China pharmacy Xu Jiaqi, director of the national drug review center, served as the honorary editor in chief Zhang Yilong, former director of Chongqing drug administration, and Professor Tao Lu, vice president and doctoral supervisor of China Pharmaceutical University 。 As part of the book's upcoming publication, as part of the fan welfare, we selected some chapters for the first time during the Spring Festival holiday, and released it on WeChat official account (yaozh008) If there is any mistake or omission in the content, you are welcome to leave a message for correction~