Chinese Government Initiatives
The Good Clinical Practice (GCP) regulations was formally issued in 1999 by the Chinese FDA (SFDA) and revised in 2003 after the new Drug Administration Law (2001) and the new Drug Registration Procedure (2002) went into effect. Chinese government spends more than $600 million annually on biotech research and development. Local governments support construction of research centers for innovation efforts. Large multinational pharmaceutical companies, such as Roche and Eli Lilly are considering locating R&D centers in China.
SFDA regulatory approval
SFDA is the regulatory body for drug and medical device approval. Drug, biological products, and medical device registration for product distribution must conduct clinical trials in China, and test articles to be used in clinical trials must be submitted to the National Institute of the Control of Pharmaceutical and Biological Products (NICPBP) for technical data and the specification verification prior SFDA registration approval. Both IND and NDA application use same process which includes pharmaceutical and biological products.
SFDA Drug Approval Process
Cost of clinical trials in China
Average cost of a clinical trial in China is about 10-25% of what similar trial will cost in the US depends on nature of product, market price, sale and time frame, medical procedures, bio-sample tests, drug importation tax, transportation cost, customs fees (drug, laboratory kits, printed materials, medical devices) custom duty, insurance coverage, and other factors.