Challenges and prospects in Chinese pharmaceutical regulatory environment

Abstract

Background China’s pharmaceutical market is growing at a healthy pace. This is due to potential rising per capita income, an increasing elderly population, urbanisation demographics and more access to health care. Methodology The methodology used is a comparative study on the basis of original empirical research. More specifically, the part of examination facts and regulation has been written by conducting empirical research on current international and national resource concerning the subject from books, various guidelines, rules and regulation, articles, published reports and internet. Results Generally the regulatory environment in China has been considered as an very challenging one. From regulatory perspective, CFDA regulations have not been stringent enough nor has it been robust enough to create a quality supply of medications, with (1) concerns in the subject matter, quality comparison between international regulatory standard and usually accepted local products and manufactures set standards; (2) a timeline for regulatory assessment and authorization of new drugs which is much longer in comparison to most countries; (3) less number of regulatory reviewer which has led to a backlog of earlier application. The journey to reshape China from ‘made-in-China’ to ‘discovered-in-China’ is highly challenging. (4) Complications with local protection, corruption and a lack of transparency. The directives from Government has recognized the need for significant system-level transformations for streamlining the pharmaceutical regulatory environment. Conclusion Continuing on the route of reform is promising that all Chinese citizens is eventually having access to safe, effective and high-quality medications in affordable price. These reformations are encouraging and promising not only for China’s health care system, but also for global Pharmaceutical industry and that’s the reason, now many big Pharma companies are considering China as a prime focus. The companies need to make use of the new opportunities, accessible to experience the benefit of faster time-to-market, and cause rewarding growth prospect for both domestic/ multinational companies.