FDA Regulations: New Drugs and Generic Drugs

Who Should Participate?

• Managers, technical staff for QA and QC, and operators of pharmaceutical companies
• Managers and staff in all levels of government Food and Drug Administrations
• Administrators and researchers in medical schools, pharmacy schools, biomedical research and academic institutions
• Administrators, doctors, and nurses of clinical sites who are conducting or about to conduct clinical trials

Objectives

With the development of Chinese pharmaceutical industry, competition in pharmaceutical market is heating up. The profit rate of generic drug is about 4% - 10% in China, while the correspondent index is about 30%-60% in global market. Many leading pharmaceutical companies in China are paying more and more attention to global of generic drug market.

According to data collected by one of the most authoritative pharmaceutical and health statistical organizations, IMS, the sales of the global pharmaceutical market was 400 billion in 2002, while the figure was 6 billion in Chinese market. China, with 1/5 of the world population, only accounts for 1.5% of the global market. Whereas, United States, with 5% of the world population, accounts for nearly 50% of world market share. Generic drug accounts for half of it and its sales reached 100 billion U.S. dollars in 2002. It is obvious that U.S. market is the mainstream pharmaceutical market. If a product is recognized by the U.S. FDA , it is relatively easier to be accepted by regulatory bodies of other countries.