On December 18th, General Secretary Xi Jinping attended the meeting celebrating the 40th anniversary of reform and opening up and delivered an important speech. The general secretary mentioned that "40 years of practice fully proved that since the Third Plenary Session of the 11th Central Committee of the Party, our party has united and led the people of all ethnic groups to develop The path, theory, system, and culture of socialism with Chinese characteristics are completely correct, and the party’s basic theory, basic line, and basic strategy that have been formed are completely correct."
　　
　　As an important part of the national economy, my country’s pharmaceutical industry has always maintained a relatively rapid growth rate, which is much higher than that of GDP. In 1978, the Third Plenary Session of the Eleventh Central Committee of the Party established the ideological line of "emancipating the mind and seeking truth from facts", thus opening the prelude to my country's reform and opening up. This year marks the 40th anniversary of reform and opening up. Looking back on the glorious course of 40 years, the rapid development of the pharmaceutical industry has benefited from the continuous deepening of reform and opening up.
　　
　　Regulations and Regulations
　　
　　 In the past 40 years of reform and opening up, the construction of my country's drug management legal system has undergone a transition from management law to regulatory law, and then to governance law.
　　
　　In 1978, the State Administration of Medicine was established, and the "Regulations on Administration of Medicines (Trial)" was implemented, opening a new chapter in the unified administration of medicines; on September 20, 1984, the seventh meeting of the Standing Committee of the Sixth National People's Congress deliberated and approved The “Drug Administration Law” was established, laying the foundation of my country’s drug administration; in 1985, the former Ministry of Health formulated and issued the “New Drug Approval Measures”, and unified approval and management of new drugs was implemented nationwide; in 1988, the former Ministry of Health promulgated my country’s first “Drugs Production Quality Management Standards", the drug production link has since entered the era of legalized supervision; in 1998, the State Drug Administration was established.
　　
　　Based on this, in the following 20 years, relying on the "Drug Administration Law", "Drug Administration Law Implementation Regulations" and other laws and regulations, my country has gradually established a relatively complete legal system framework; at the same time, it has covered the entire life cycle of the administration of drugs. Regulations and a quality management standard system for full-process control have also been established and perfected.
　　
　　Drug Development
　　
　　In 1978, the sales revenue of my country's pharmaceutical industry was about 7.3 billion yuan. In 2017, this value was 2.53 trillion yuan, an increase of about 346 times over 1978; the export scale of the pharmaceutical industry increased from US$280 million in 1978 to 2017 The year’s 60.8 billion U.S. dollars, an increase of 217 times, the import scale increased from 40 million U.S. dollars to 55.88 billion U.S. dollars, an increase of 1397 times.
　　
　　 After the Third Plenary Session of the Eleventh Central Committee, the development of my country's pharmaceutical industry has gradually entered the "fast lane". In the early ten years of reform and opening up, Class 1 new antimalarial drugs and related products represented by artemisinin have made great contributions to global malaria prevention and control; in the following 20 years, my country has successively developed 78 kinds of products with independent intellectual property rights. Innovative drugs; during the "Twelfth Five-Year Plan" period, a total of 210 innovative drugs in my country have been approved and more than 110 new chemical generic drugs have been listed.
　　
　　 represented by icotinib, apatinib, conbercept, etc., a large number of blockbuster new drugs with significant clinical value have been approved for marketing in my country, ushering in a new era of innovative drugs in China. Recently, the first class 1.1 new drug Roxastat Capsules, the first global research and development in China, was approved for marketing in China. This new drug will provide more convenient and safer treatment options for patients with renal anemia in China. At present, the drug is not yet on the market in other countries, which also shows that the Chinese market is increasingly important in the global pharmaceutical market.
　　
　　At present, China's raw material drug production market share and the number of biosimilar research and development are ahead of other countries in the world. China has become the largest pharmaceutical innovation base in Asia, and the number of new drug research and development companies it owns ranks TOP3 in the world. China's clinical trials are launched. The number is ranked TOP4.
　　
　　 In 2015, my country's pharmaceutical market accounted for 10.8% of the global market, surpassing Japan to become the world's second largest pharmaceutical market. In 2017, the former State Food and Drug Administration officially became a member of the International Technical Coordination Committee for the Registration of Drugs for Human Use (ICH), and China has taken another historic step on the road to the internationalization of drug R&D and registration. After joining ICH, the pace of my country's drug review and approval reform will also accelerate.
　　
　　 On July 19, 2018, the "2018 Fortune Global 500 Ranking List" was officially released. A total of 13 pharmaceutical companies worldwide were on the list, with China Resources and China National Pharmaceutical Group occupying two positions. In the international market, Chinese local pharmaceutical companies hold more than 430 US ANDA approval document numbers, and are looking for high-quality assets to buy and buy globally. Chinese pharmaceutical companies have become an important force in the international capital market in recent years.
　　
　　Medical Insurance Coverage
　　
　　 Around 1978, there were about 170,000 domestic medical and health institutions, and the overall medical standards were poor. Minor illnesses basically depended on the burden, while serious illnesses basically depended on procrastination, especially in remote areas where there was a shortage of doctors and medicines.
　　
　　In September 1978, the World Health Organization listed my country as a model for the implementation of primary health care in developing countries in the "Almaty Declaration"; Medical institutions implement reform policies that encourage income generation and self-development, which is called the "first year of medical reform" in my country.
　　
　　In December 1998, the State Council issued the "Decision on Establishing a Basic Medical Insurance System for Urban Employees" to promote the basic medical insurance system for urban employees across the country; during the five years from 2003 to 2017, the "Opinions on Establishing a New Rural Cooperative Medical System ”, “Guiding Opinions on the Pilot Program of Basic Medical Insurance for Urban Residents”, “Social Insurance Law of the People’s Republic of China”, “Guiding Opinions on Carrying out Major Illness Insurance for Urban and Rural Residents”, “Notice on Accelerating the Promotion of Major Illness Insurance for Urban and Rural Residents”, "Guiding Opinions on Further Completing the Settlement of Basic Medical Insurance Medical Expenses for Medical Treatment in Different Places", "Opinions on Fully Implementing Major Illness Insurance for Urban and Rural Residents", "Notice on the Implementation of the Pilot Program for the Combined Implementation of Indian Childbirth Insurance and Basic Medical Insurance for Employees", etc. After the announcement, my country's medical insurance system has been gradually improved.
　　
　　In March 2018, the newly formed National Medical Security Administration, as an agency directly under the State Council, integrated a number of departmental responsibilities: the Ministry of Human Resources and Social Security’s basic medical insurance and maternity insurance responsibilities for urban employees and urban residents, and the National Health and Family Planning Commission The responsibilities of the new rural cooperative medical system, the responsibilities of the National Development and Reform Commission for the price management of medicines and medical services, and the responsibilities of medical assistance for the Ministry of Civil Affairs.
　　
　　As of 2017, the number of domestic medical and health institutions has increased to 987,000, and the level of medical care has been qualitatively improved. Thanks to the coverage of medical insurance and the structural optimization of the total national health expenditure, the proportion of personal health expenditures of Chinese residents has declined trend. In the same year, the number of domestic residents covered by my country's basic medical insurance exceeded 1.35 billion. The urban and rural residents' major illness insurance system established on this basis covered 1.05 billion people. The rate of reimbursement of compliance medical expenses for patients with serious illness increased by an average of about 12%. In October 2018, the "National Essential Drugs Catalog (2018 Edition)" was officially released. The number of drugs included in the medical insurance catalog increased to 685, the coverage continued to expand, and the reimbursement ratio continued to increase. The catalog was officially launched on November 1. Implement.