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FDA's Presence in China - A Momentous Event
After reading our article on the FDA's plans to open a new office in Beijing (story), and Genetic Engineering News' source article (article), I felt it might be interesting to give a somewhat different perspective based on our direct experience here in China.
First, this is a momentous event in China's drive to be a world power in drug development. Assuming the Beijing office is approved, and we've been told it's virtually a done deal, this will be the first time there is a major collaboration between the China SFDA and the US FDA. While this is initally focused on cGMP certification, driven by the compelling need for safe drugs by both countries, I believe the scope will expand quickly to include the drug approval process.
We're also hearing that the FDA will open two additional offices in China, including one here in Shanghai, generally regarded as the center of drug development in China. This is perceived as a good thing by all. In addition to addressing the need for additional inspections, which will also help speed cGMP certifications, having FDA staff here should give greater access to much needed US regulatory expertise.
And while lack of regulatory experience is definitely a problem now, this is changing rapidly. Most of the big pharma and many of smaller biotechs here have brought serious FDA expertise to China. For example, I met a Chinese returnee at our BioBay Investor Forum yesterday in Suzhou who had been with the FDA for 15 years. And virtually all of the CROs - clinical and pre-clinical - are rushing to shore up this deficit. I expect this problem will be largely addressed in the next two years.
Even the government controlled National Drug Evaluation Centers here (there are eight) have been given the mandate to do global quality work. We recently met with the directors of two, and one has formed an alliance with a local leading CRO that has strong US connections, and the other has already performed some pre-clinical studies that have been used for FDA submissions. Both are looking to do much more FDA work.
I have to take specific exception to the following quote in the GEN article:
- 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.
China's SFDA has very rigorous pre-clinical IND requirements for new molecular entities that have been in place for several years. They are even more rigorous than the FDA's, requiring six month toxicity studies in two species, rather than the typical one month tox in the US. And the IND approval process for NMEs in China can take anywhere from 4-6 months at best, to as long as 18-24 months, versus the US's 30 day "default approval" process.
Dr. George Haley, author of The Chinese Tao of Business, was quoted by GEN as calling the State Food and Drug Administration the "Sino-FDA." Hopefully that's a reporting error, and not an error on Dr. Haley's part. It's the State FDA. And he is also quoted as saying the "SinoFDA" [sic] is in its infancy. Technically that might be true, as it was founded in 2003, but it was essentially a reorganization and expansion of responsibilities of the State Drug Administration (SDA), which had been founded in 1998. So, with ten years of history, I would say this is more of an adolescent organization.
I also don't buy that there's any significant provincial/central government issue, especially in drug development. The central government is very powerful, and, as I was told by a Shanghai government official, if you go against it, you WILL lose.
The good news is that the central government, through its 863 Program, the 11th Five Year Plan, and other directives, has put drug development as a top priority. Dr. Qimin Zhan, Chief Scientist for the 863 program, presented plans for the 863 program at the recent BioBay Investor Forum in Suzhou, presented by ChinaBio. The 863 program funds much of the early stage development here in China, and they are planning to launch a new program similar to NIH. (I'll try to get an article out on Dr. Zhan's talk shortly.) Suffice it to say that 863 will mean China becomes one of the worldwide centers of innovative drug development.
And then there's my cardinal rule - NEVER underestimate China. Just witness the Olympics - 51 golds and the best opening ceremony ever. And a great theme song - You and Me - signalling China's intent to participate as a partner on the world stage.
What's next for China drug development? Stay tuned, as it may be the next Olympics for China.