China possesses a fourth population in the world and has one of the largest drug markets round the world. China is expected to be the fourth largest pharmaceutical market by 2010 as the average annual growth rate of China market has been above 15% since 1978. In 2008, the total pharmaceutical market size (including API, checimical finished product, biological product, and Traditional Chinese Medicine, and medicinal Instrument) in China was around USD 100 billion, and the chemical finished product market size was around USD 30 billion.
China pharmaceutical regulations are still under way to be streamlined and going to be more consistent with international standards. Previously, one of the major concenn from the global pharmaceutical companies is that the lengthy approval process in China. Now days, it changes better and better, followed by the major revision in Oct, 2007, the On-site Inspection for Drug Registration was introduced on May 2008, and the newly regulation of "Special Drug Review Approval Process" & Re-registration of Imported Drugs was introduced in Jan 2009.
Since the reform and open door policy implemented by Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2006, sales of imported drugs have shared one fifth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of such drug market. To enter such a lucrative drug market, the first obstacle faced by overseas pharmaceutical manufacturers and producers is how to file the application for their imported drug registration with Chinese pharmaceutical authorities. In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency.
Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has been become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market. In despite of since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and become increasingly compatible with international standards, in turn, its ongoing consolidation will eventually contribute to a healthier market environment.
In China, like in other Western countries, the pharmaceutical authority ---- SFDA requests applicant to submit complicate and reliable materials for application of imported drug registration. Therefore, to achieve a successful application and approval for imported drug registration in China, overseas pharmaceutical manufacturers and producers must understand the more depth and detailed regulations on registration application for various imported drugs.