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Laura Bush was editor in chief of BioPharm International.
Many companies acknowledged that Western regulatory standards are tougher than those in China.
Considering an issue from afar, it is easy to have a opinion. As the matter approaches, however, it often seems more complex. Two recent experiences forced me to look more closely at topics I had previously discussed in this column.
At this time last year, following the November 2006 elections, I celebrated the stem cell vote. Stem cell research was a pivotal issue in races all over the US, and overwhelmingly, people voted in favor. I exulted in the good news: Americans believe in technology and progress.
This year, New Jersey posted a ballot question to provide $450 million in public funding for stem cell research. Now that the issue had arrived in my own state, I had to question my values. Money, it turns out, was the key concern. As the state struggles to pay teachers' pensions and the governor considers pawning off a toll highway because we need the cash, pouring so much state money into stem cell research felt ill advised. The majority appeared to share this view, because the initiative was defeated.
A recent trip to China gave me the opportunity to re-evaluate another matter I had discussed a few months ago. In August, I questioned whether the Chinese government's execution of Zheng Xiaoyu, the corrupt head of its State Food and Drug Administration, was a gesture for the West or truly a sign of change. A trip to the API China–Interphex China exhibit, held November 13-15 in Shenzhen, provided the opportunity for a closer look.
A walk through the show floor revealed an incongruous mix of GMP manufacturers of active pharmaceutical ingredients—some proudly displaying enlarged copies of approval letters from the US FDA—and suppliers of traditional Chinese medicine whose booths were filled with vials of mysterious powders and tangled roots. Although those supplement makers were presumably targeting only the domestic market, their presence signals that many players do not yet make hard distinctions between regulated and non-regulated industries.
On the other hand, I spoke to several Chinese API manufacturers who have passed manufacturing inspections by US or European regulatory authorities. Such companies were frank in acknowledging that Western quality standards are much higher than Chinese requirements. They noted, though, that Chinese regulations are getting tougher. They also acknowledged, at least for injectables, that although they could meet foreign standards for APIs, they were not yet ready to meet foreign standards for finished pharmaceutical products. Indeed, in conversations with Western industry experts at the show, the need to ramp up Chinese cleanroom technology and expertise was a common thread. Those Western experts, however, all seemed pretty confident that it is only a matter of time before the Chinese industry gets up to speed. The best local companies too, can see the competition strengthening around them. "Two other companies from our province just passed a US FDA inspection," noted one manager.
Thus, this closer examination led me to believe that the Chinese pharmaceutical industry and its regulation are indeed slowly rising to international standards, albeit unevenly and gradually. That, of course, is the way things change everywhere.
Laura Bush is the editor in chief of BioPharm International, firstname.lastname@example.org