TAIPEI, Taiwan – When Taiwan and China signed the Economic Cooperation Framework Agreement (ECFA) in June 2010, the two politically opposed sides pledged to remove some of the barriers that have kept them separated since the end of the Chinese civil war of 1949; economically, if not politically. That agreement has implications that go beyond regional economics. Because of the ECFA, Taiwan may be slowly positioning itself to become an important gateway into the immense market of China for overseas drug companies.

Following on from ECFA, the Cross-Strait Cooperation Agreement on Medicine and Public Health was signed in December 2010, with both sides pledging to accept each other's clinical data in the drug approval process. That means, on paper at least, that the China Food and Drug Administration (CFDA; previously known as the SFDA prior to a restructuring in March 2013) would allow a Phase III trial to go ahead based on data from a Phase II trial previously conducted in Taiwan and approved by Taiwan's regulatory body, the TFDA. And, if successful, approval for marketing in China would follow on as well.

It's an attractive prospect for global pharmaceutical companies as it presents the best of both worlds: access to the huge market of China, while taking advantage of Taiwan's clinical trial infrastructure.

GlaxoSmithKline plc, of London, as one of the biggest investors in clinical development in Taiwan, is following developments closely. GSK Taiwan general manager Thomas Willemsen explained the attraction of Taiwan as a clinical trial location. "Taiwan has a fantastic infrastructure, with very well educated doctors," he said. "And the proximity of the medical centers is good: close to doctors and patients, which makes it easier to recruit. And what could be even more important for Taiwan in the future as a developer is the proximity to China and the ethnic similarities."

Willemsen also said that if Taiwan's well-regarded medical centers become accepted and accredited by China, pharma companies would be flocking to the island to conduct trials.

"Trials in Taiwan are so much cheaper. The approval timelines from IRBs [institutional review boards] is a couple of months. In China, it can take a year," he said.

"If data are accepted for Phase III in China, then you don't have to do a Phase I and II again, so that's the benefit. Or, you could even do proof-of-concept trials here, meaning that you would have less risk doing a trial in China, because you already know the concept works in Chinese people," he added.

However, progress toward that goal is moving at glacial pace. With representatives from the TFDA having met with the CFDA in Chengdu, China, in December 2012 to hash out some of those issues, Gau Churn-Shiouh, executive director of Taiwan's Center for Drug Evaluation – the technical arm of the TFDA – lamented the slow speed of talks during a panel discussion at the recent Taiwan Trials 2013 conference in Taipei.

"We are waiting on the conclusion of the December meeting. The meeting minutes are still being considered by the CFDA. Maybe they'll confirm them in one or two months," she said.

Taiwan Tests the Harmony Waters

To jump-start the process, Taiwan's Department of Health has designated a group of select companies with drugs nearing market approval – the so-called Cross-strait Drug Project – to test the scope of that cooperative agreement.

Project members include drug development companies Medigen Biotechnology Corp. and TaiGen Biotechnology Co. Ltd., both of Taipei, and both with drugs in Phase III trials in Taiwan and China. Their experience in the months to come will be a useful window into the process for overseas pharma companies.

Medigen is taking drug candidate PI-88 for postsurgery-stage liver cancer through a multisite Phase III trial in Taiwan, Korea, Hong Kong and mainland China, with a total of about 500 patients enrolled. Phase II trials were conducted earlier in Taiwan. Theoretically, if the global trial is successful, a new drug application (NDA) can be submitted in China. However, it's by no means certain.

"There is a possibility we will get approval in three countries at the same time [Taiwan, Korea and China]. But up until now, we have still not received a firm confirmation from China, so it's still a bit unknown," said Stanley Chang, Medigen's CEO.

TaiGen is set to announce very soon what CEO Hsu Ming-Chu said will be a first under this cooperation framework: a joint NDA filing for its nonfluorinated quinolone antibiotic Nemonoxacin.

"It will be a first under ECFA, a combined NDA for Taiwan and China," Hsu said, also speaking at the Taiwan Trials 2013 conference. Hsu stressed, however, that Nemonoxacin had already undergone Phase I and Phase II trials in China; the milestone here is that the NDA combines data from Phase III trials in both countries, with approval by both the CFDA and TFDA expected at around the same time.

It's a small step toward full cross-strait data acceptance, but a step nonetheless.