Lack of Government Control
“It’s more than lip service, and the issue is complex,” pointed out George T. Haley, Ph.D, author of the Chinese Tao of Business and business professor at the University of New Haven. “People don’t really understand the way things work in China. We think there’s a central government, but that government is finding it impossible to control anything in the provinces.”
That lack of control is causing China to “let go of the small and hold the large,” Dr. Haley elaborated. Therefore the small and medium-sized businesses that constitute much of the API industry are regulated by municipal or provincial governments. This has led to discrepancies because the supply chain is fragmented.
“Look at the pet food scandal,” Dr. Haley remarked. “The company responsible was being protected by the local government. The central government found it impossible to track the problem because the company, officially, had closed.
“The offending company was discovered by a reporter who talked with a taxi driver who talked with a trucker who spoke of deliveries that were still being made to the closed plant.” Obtaining such information is one of the presumed goals of FDA’s anticipated presence in China.
Another challenge for China is its historical lack of a rigorous pharmaceutical regulatory environment. “There’s never been a preclinical submission process in China,” reported Chris Perkin, president of preclinical services for Canada and China at Charles River Labs (www.crl.com). The reason is that until recently, most Chinese medications were based upon natural products, according to Perkin.
Because meticulous regulatory guidance has been absent in China, biopharma companies operating there today often find it necessary to train key staff members in the West. That helps ensure that the rigors of GLP and GMP environments are understood and increases the likelihood that the necessary steps will be taken to ensure that the final product is as per the FDA’s requirements.
“China has a reform movement and a version of the FDA—the Sino FDA—that is working with the U.S. to adopt similar regulatory controls,” Dr. Haley noted. The Sino FDA is in its infancy but is poised for rapid growth.
Currently, it is allowing itself to be guided by the standards accepted by industrialized nations. The SinoFDA is requesting training and guidance. “The FDA has conducted training courses since at least 2004,” according Perkin. For the time-being, therefore, the FDA has some influence in shaping China’s pharmaceutical regulatory policy as it strives to attain world-class standards.