Work summary and 2014-2015 work arrangement of the 9th general meeting of China Pharmaceutical Industry Research and Development Promotion Association

- on October 27, 2014, at the first meeting of the 10th general meeting, song Ruilin, executive chairman, member representatives: entrusted by the chairman's meeting, I will report to the general meeting the work of the ninth general meeting of China Pharmaceutical Industry Research and Development Promotion Association (hereinafter referred to as "CMPA") in the past four years, and Suggestions are put forward for the work of the year Please consider them The first part reviews the work of the past four years The four years of the ninth general meeting since 2010 are the four years of pioneering significance in the development history of the drug promotion association At the first meeting of the ninth session of the general assembly in April 2010, sang Guowei, vice chairman of the Standing Committee of the Eleventh National People's Congress and academician of the Chinese Academy of engineering, was elected president of the association Since then, the drug promotion association has opened a new era In accordance with the spirit of the CPC Central Committee and the State Council to encourage the innovation and development of the pharmaceutical industry, President sang Guowei established the tenet of "innovation, industrialization and internationalization" for the association The function of the association is to serve the representatives of innovative pharmaceutical enterprises, promote the construction of the enterprise centered production, learning and research system, and promote the war of China's pharmaceutical industry from imitation oriented to independent innovation oriented Finally, it will serve the people's health Under the guidance of the new tenet, the drug promotion association constantly innovates the internal governance structure and system mechanism, improves the ability and level of serving the member units; promotes the mutual exchange and innovative development of the member units and the whole pharmaceutical industry through holding various forums, conferences, large conferences, etc.; and jointly promotes the Chinese and foreign pharmaceutical industry through cooperation with foreign embassies, foreign industrial organizations and enterprises in China The cooperation and exchange of the industry sector will build an international exchange platform for member units; provide medical information collection, collation, evaluation and consultation services; carry out research on major medical policy issues at home and abroad with the support of relevant government departments and pharmaceutical enterprises, and provide decision-making reference for the government Through more than four years of efforts, the drug promotion association has made great progress in institutional construction, member services, public services, etc., and has initially formed a modern social organization system with reasonable structure, perfect functions, separation of government and society, clear responsibilities and rights, autonomy according to law, integrity and self-discipline In the past four years, the main work and characteristics of the drug promotion association are reflected in the following five aspects 1、 Through innovation and improvement of internal governance structure, in order to achieve the new purpose and functional orientation of the association, the association has carried out a series of reforms 1 In order to improve the work efficiency and give full play to the role of member units in the management of the drug promotion association, the association will no longer set up a Council and a standing council, and all the powers will be exercised by the general assembly to give full play to the role of the general assembly 2 In order to ensure the implementation of resolutions and decisions adopted by the general assembly, improve work efficiency, establish a chairman's meeting system composed of chairman, vice chairman and secretary general, exercise the main powers of the general assembly when the general assembly is not in session, and consider major issues of the drug promotion association Through on-site or communication, the drug promotion committee holds several meetings of its president every year to solve major problems in the development process in a timely manner 3、 In 2012, due to his age, academician Sang Guowei voluntarily proposed to no longer serve as president In order to give full play to the role and enthusiasm of member units and learn from international experience, CFDA has formulated relevant regulations and tried to implement the rotating president system: the president is elected from members for a term of one year Up to now, Chen Qiyu, chairman of Shanghai Fosun Pharmaceutical Co., Ltd and Yan Xijun, chairman of the board of directors of Tianjin Tianshili group have served as two rotating presidents The rotating president is responsible for convening the president's meeting, organizing and implementing the resolutions of the general meeting, and leading a delegation to visit and attend major activities on behalf of the drug promotion association Practice has proved that the implementation of this system has made the drug promotion association take the lead in the reform of member participation and democratic running of the association, which is of great significance for improving the activity ability and level of the drug promotion association and supported by the majority of member units 4 In order to improve the level of autonomy in accordance with the law, the drug promotion association strengthened the construction of internal institutionalization and rule of law, and formulated corresponding system documents for a series of major innovative initiatives, including the amendment of the articles of association, the establishment of the president's meeting system, the rotating president election method, membership and management methods and other normative documents 5 In order to enhance the service capacity of the drug promotion association, the construction of the Secretariat has been continuously strengthened First of all, strengthen the human resources construction of the Secretariat and establish a team to meet the development requirements of CFDA At present, there are 19 employees with an average age of 36, 10 of whom have master's degree or above, accounting for 55%; and internal functional departments such as office, finance, human resources, research department, international department and information department are set up Secondly, strengthen the standardized management of the Secretariat A series of internal rules and regulations, including financial management, fixed assets management, attendance management, seal management, writing management, certificate management, safety management and research project management, have been formulated to make the work of the Secretariat have rules to follow and step into the track of standardized management 2、 To provide services for the innovation and development of member units in order to improve the innovation ability of member enterprises, the drug promotion association serves for the innovation and development of member units by promoting the cooperation between member enterprises and local governments, scientific research institutes, organizing important meetings, etc The main contents are as follows: 1 With the support of Liaoning provincial government and Beijing Municipal Health Bureau, member enterprises, Shenyang Pharmaceutical University and Beijing Tiantan Hospital, respectively, were organized to form a strategic alliance of innovative drug R & D, production, learning and research 2 In cooperation with Sinopharm group and Fosun Pharmaceutical Group, we applied for the construction of "new drug development platform", and obtained the approval of major special project of new drug development Three , hosted the Beijing report meeting of "12th Five Year Plan" of major science and technology projects of "major new drug creation", invited academician sang Guowei, President of our society and chief technical engineer of national major new drug innovation technology projects, to make a theme report, introduced and analyzed the great challenges brought by the serious imbalance of global new drug R & D input and output, the latest trend of international new drug R & D, and the "11th Five Year Plan" of China ”During this period, the main progress of new drug development was made, and the overall goal and strategic focus of innovative drug research and development during the 12th Five Year Plan were put forward 4 The "Summit Forum of innovative drug industry alliance for cerebrovascular diseases" has been held for many times to promote exchanges among medical, industrial and academic circles Since 2010, it has held five consecutive "China Hospital Pharmacy policy forum" with China Pharmaceutical Association, taking the lead in building a platform for dialogue and exchange between clinicians and clinical pharmacists across the country, and studying such major issues as translational medicine and the status and role of pharmacists 5 Assist the member enterprises to hold the national major new drug creation achievement conference, and publicize the innovative drugs of the member enterprises, such as the target drug "exetane hydrochloride" for the treatment of non-small cell lung cancer of Beida Pharmaceutical Co., Ltd., and Kanghong Pharmaceutical Co., Ltd for the treatment of wet age-related macular degeneration (AMD), a class of new biological drugs - conbercept ophthalmic injection In cooperation with Zhejiang Beida Pharmaceutical Co., Ltd., China Council for the promotion of drugs launched a follow-up free drug use activity for all patients who had been treated with "exetinib hydrochloride" for 6 months or more As of August 31, 2014, a total of 101114 people, 404456 boxes, worth about 1.1 billion yuan, have been distributed, and 65 pharmacies have been opened as designated free drug free pharmacies This shows that the achievements of medical innovation in China can benefit the majority of patients, reduce medical costs, and provide a solid material basis for the cause of medical reform in China 6 Through various channels such as the Central Committee of the agricultural labor party, we can reflect the needs of member enterprises to encourage pharmaceutical innovation The drug promotion association has participated in the research organized by the rural labor party for many times, accompanied the leaders of the Central Committee of the rural labor party to visit member enterprises, and submitted policy suggestions to the Central Committee to encourage pharmaceutical innovation through the rural labor party 3、 Research on major medical policy issues at home and abroad Over the past four years, CCPD has successively undertaken more than 30 research projects entrusted by ministries and enterprises such as the health and Family Planning Commission, the Ministry of human resources and social security, the Ministry of industry and information technology, the State Food and drug administration, the State Administration of traditional Chinese medicine, etc., covering such topics as the basic drug system, drug evaluation mechanism, drug bidding and purchase, drug price and protection of pharmaceutical intellectual property rights, and has submitted them to the State Council, relevant departments and local governments The government put forward the Research Report and relevant policy suggestions 1 Research on the system of essential drugs The drug promotion commission has accepted three related topics entrusted by the drug administration department of the health and Family Planning Commission, including the policy framework, legislative elements and accessibility of essential drugs In view of the disadvantages and harms of the "lowest price bid winning" provision in the bidding and procurement system of essential drugs, the drug promotion committee has done a lot of work, held many enterprise and expert symposiums, formed research reports and submitted them to the leadership of the State Council, the medical reform office of the State Council, the national development and Reform Commission, the Ministry of industry and information technology, and the health and Family Planning Commission In October 2010, Li Keqiang, then Vice Premier of the State Council, made important comments on the report of the Council In 2011, the pharmaceutical promotion association led and cooperated with five other associations to draft the proposal on the healthy development of the pharmaceutical industry, calling on the pharmaceutical industry to strengthen self-discipline, integrity, law-abiding and standardized operation After the meeting, the six associations jointly wrote to the medical reform office of the State Council, the national development and Reform Commission, the Ministry of industry and information technology, and the Ministry of health, and put forward suggestions on revising and improving the "two envelope" system of bidding and purchasing of essential drugs With the joint efforts of colleagues from all walks of life, the plan and implementation plan for deepening the reform of medical and health system during the 12th Five Year Plan issued by the State Council has adjusted the relevant contents of the basic drug system For the first time, it is clearly proposed that "we should not only reduce the false high drug price, but also avoid the vicious competition of low price, so as to ensure the safety, efficiency and timely supply of basic drugs" And recognize the current situation of quality level in China's pharmaceutical industry 2 Research on drug review mechanism Whether the drug evaluation mechanism is perfect or not is directly related to the initiative of independent innovation of pharmaceutical enterprises, the development of pharmaceutical innovation and the improvement of the overall quality of drugs in China, and then to the development of China's health industry and the realization of the goal of medical reform To this end, we have kept close contact and communication with the registration department, the legal department and the review center of the food and drug administration, and cooperated with them to carry out the following three related research work: first, we have studied how to solve the problems such as the serious shortage of personnel in China's drug approval agencies, the serious backlog of review tasks, and the mismatch between the tasks undertaken and the organization structure The drug promotion committee held discussions with the relevant responsible comrades of the food and Drug Administration for many times, and organized a symposium attended by the relevant responsible comrades of the food and Drug Administration and the responsible comrades of the relevant departments and representatives of the innovative enterprises of the drug promotion committee in September 2012 The drug promotion committee specially wrote the report on improving drug evaluation mechanism and promoting the innovation and development of medical reform and pharmaceutical industry In the report, we suggest that: reform the drug review fee system; establish a conditional and time bound expert system for drug review of contract system, so as to improve the ability and efficiency of drug review The report was highly valued by the food and drug administration, the editorial office of CFDA, the Ministry of Finance and other departments The Xinhua news agency also specially asked for a draft to be reflected in the internal reference submitted to the central leadership Second, actively participate in the revision of measures for the administration of drug registration In November 2013, we held a symposium for member enterprises and invited leaders of the registration department to attend the symposium