Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Impact of China's regulatory reforms on business operations in Chinese pharmaceutical market: Perspectives and Challenges for multinational pharmaceutical companies ***

Sofia Dust (Abschlußjahr: 2018)

Summary
Language: English
As the second-largest in the world, China's pharmaceutical market is one of the most promising market for multinational pharmaceutical companies. Not only due to its population size but also a rapidly aging population, rising per capita incomes and greater access to healthcare enhance the appeal of China's market to overseas companies.
However, China’s drug regulatory system has been considered as a highly challenging one with heavy backlog of applications for both drug approval and clinical trial registration due to the complexity and lengthy of the review and approval process, the volume of applications and understaffing of reviewer who are responsible to process these applications. To improve the process of drug review and approval, Chinese government recognized the integration of the Chinese clinical study into international multi-center clinical trial in the 2002 issued 'Drug Registration Regulation'. The major drug registration reforms begun in 2015 with the announcement on several policies regarding review and approval of drug registration. China's efforts to reform the drug and medical device review and approval system culminated in the issuance of a central government directive in the end of 2017. This issuance is followed by a flood of CFDA implementation measures in a timely manner.
Besides the changing environment in China’s drug regulatory system, major changes also take place in the environment of China’s state market regulatory administration. Following widespread discontent at the healthcare situation in China due to rapid growth of drug expenditures which has contributed to serious burdens for patients as well as to combat the perverse incentives created by the 15% mark-up policy, China´s central government officially issued significant reforms in 2009 with the goal to provide affordable and equitable healthcare for all. Since 2015, an ongoing series of reforms concerning regulation of Chinese pharmaceutical expenditure have been revised or developed, resulting in far-reaching impact on the pharmaceutical market in China.
In this master thesis, the changing environment of both China’s drug regulatory system and China’s state market regulatory administration are described. Here, the main focus is keeping on the impact of the announced reforms on multinational pharmaceutical companies’ business operations in China, with a special emphasis on the opportunities and challenges with which the companies may be faced.
Pages:49