China Council for the promotion of drugs and American pharmaceutical research and Manufacturers Association held "policy seminar on innovation and development of pharmaceutical industry" (visiting the United States and Canada series 4)

Source: on the morning of July 11, 2013, China Council for the promotion of drugs and American pharmaceutical research and Manufacturers Association (hereinafter referred to as Pharma) held the "seminar on innovation, development and policy environment of pharmaceutical industry" in Washington, D.C The meeting was attended by song Ruilin, executive chairman, Chen Changxiong, executive deputy secretary general and Wang Xin, deputy director of international affairs Pharma attended the meeting by Jennifer Osika, assistant vice president of international affairs, David Korn, vice president of intellectual property, Richard kjeldgaard, assistant vice president of intellectual property, and Patrick Brady, assistant vice president of science and technology policy The meeting discussed the development and reform of the pharmaceutical industry in the United States, the prescription drug user fee law, global synchronous development, intellectual property protection and many other issues Dr Timothy franson, Dr Gregory ENAs and Dr Yonghao Hou, three experts from fargre BD consulting company, a Pharma consulting unit, respectively made thematic reports Dr Timothy franson presented a keynote report entitled "the evolution of innovation and regulation in the pharmaceutical industry in the United States" He reviewed in detail the development of American pharmaceutical industry from the Second World War to the present, the historical changes of American drug regulatory system in various stages, the important legal system of American drug regulation and the challenges faced by the innovation and development of the pharmaceutical industry He pointed out that scientific research, regulations, political supervision and incentives are usually important factors to promote the development of the pharmaceutical industry In the past 30 years, the research and development focus of the pharmaceutical industry has been "from acute to chronic diseases, from small molecules to biological drugs, from brand drugs to mixtures" Among them, GXP rules (including GLP, GCP, GMP, GSP, GPP) and other common representatives constantly change the implementation and inspection standards For pharmaceutical companies, clear decision-making, early participation in policy research, the establishment of evidence-based key project platform, grasping patients' needs, and the realization of "action, data protection and cooperation" should be organically combined Looking forward to the future, Dr franson said that the complexity of drug development is gradually increasing and the degree of internationalization is deepening This process requires the joint participation and cooperation of global enterprises Dr Timothy franson made a second report, which detailed the drug review fee system in the United States In 1992, the U.S Congress passed the prescription drug user fee Act (PDUFA), which amended the federal food, drug, and Cosmetic Act and authorized the FDA to charge the pharmaceutical companies applying for innovative drugs The purpose of this act is to speed up the approval review of FDA's new drug applications and reduce the backlog of applications The Council has stipulated that PDUFA should review every five years to see if it meets the expected targets On July 9, 2012, President Obama signed the food and Drug Administration's safety and innovation act (fdasia), which will provide FDA with more than $6 billion in industry user fees over the next five years to fund the agency's drug and medical device review process and authorize FDA Fees are charged to pharmaceutical companies that declare generic and biosimilars and include a range of provisions to improve regulatory processes The drug review and charging system in the United States provides more resources for review agencies, improves the speed of approval, improves the approval system, and allows patients to use innovative drugs as early as possible Dr Gregory ENAs reported in detail on issues related to global synchronous development (SGD) Global synchronous development (SGD) refers to the simultaneous study of patients in all regions according to the same scheme generated by a single database, and then for the corresponding regulatory agencies to analyze and review at the same time, so as to realize the simultaneous marketing of the same drug in different regions The human drug registration requirements coordination meeting (ICH) has played a positive role in promoting SGD He pointed out that the key success factors of SGD are comprehensive support for innovation, R & D, clinical, regulatory, pricing and intellectual property Dr ENAs also made a number of specific recommendations on SGD regulatory considerations Dr Yonghao Hou presented a keynote report entitled patents and innovations in life sciences She made a detailed introduction to the relevant contents of the patent law system in the United States, the background, main contents and impact on the innovation and development of the pharmaceutical industry of the Bayh Dole act and hatch Waxman act, the approval of bio generic drugs, etc., and discussed the details and cases of relevant laws with Chinese representatives Representatives of China and the United States had in-depth discussions on relevant issues during the reporting process According to song Ruilin, the executive chairman, China's pharmaceutical industry is changing from imitation based to combination of imitation and innovation, so more and more attention is paid to the protection of intellectual property rights The cooperation between the pharmaceutical industry of China and the United States has an increasingly important impact on the bilateral relations Like many multinational pharmaceutical companies, the member enterprises of China pharmaceutical promotion association pay close attention to pharmaceutical innovation, R & D and intellectual property protection, which is also the common aspiration and pursuit of global pharmaceutical companies Finally, song Ruilin, executive chairman, introduced the preparations for the "2013 International Pharmaceutical Innovation Summit Forum" to be held by CFDA in October He hoped that through this summit, the government and industry at home and abroad would pay more attention to the pharmaceutical innovation, promote the innovative development of the pharmaceutical industry, and improve the level of health security of people around the world Meeting site between Song Ruilin, executive chairman and Dr Timothy franson of faegrebd company