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Great Stall of China

Regulartory paperwork further slows drug approval

Patience is a necessity for pharmaceutical companies seeking to bring drugs to market in China. Last year, the six-to-eight-year drug lag these firms have had to contend with was lengthened another two years. “A lot of products were asked to queue in the line again to get the approval for clinical trial stage,” says Joseph Cho, who heads RDPAC, an association of 40 multinational R&D-based pharmaceutical companies working in China. The extension was unexpected. “We say it is a shock, not a surprise,” he relates.

Since being recognized in 2005 as a nonprofit by the Chinese government, RDPAC has developed into a lobbying voice for improving China’s pharmaceutical R&D environment. According to its website, the organization is “committed to securing patients timely access to innovative drugs”—a formidable task, particularly in China. As of early January 2015, the group reports that at least 34 applications from multinational drug companies have been delayed by a new step in the drug-approval process. And in addition to these global firms, says Cho, “The domestic companies who are focusing on their own R&D products are facing the same challenges.”

RDPAC is working hard for change, but has had limited success so far. The real challenge is getting the ear of the right high-level decision makers. “Policy making in China is so fragmented, so we are facing different ministries and sometimes they come up with different ideas about how things should be done,” says Cho. At RDPAC’s March 2014 meeting with China’s State Food and Drug Administration (CFDA), officials revealed the government’s rationale for the added two years. “They think they have been making mistakes in the past, and they just want to do the right things,” he explains. 

Indeed, the CFDA is playing catch-up with the pharmaceutical R&D industry. Whereas in the past it reviewed mainly generics, since China joined the World Trade Organization in 2001 the agency has seen an enormous increase in the registration of innovative medicines. “Now they have their own R&D pipeline from China and around the world,” Cho says. “They need to be able to cope with the advancement of the pharma R&D here. That is a very huge challenge.”

Last year, the CFDA announced the recruitment of 20 new Center for Drug Evaluation employees, adding to its existing staff of 80 overworked reviewers, and earlier this year they announced the addition of 53 reviewers. In May, CFDA deputy head Yin Li announced plans to outsource some of the reviewing to third-party organizations.  Even so, its capabilities don’t compare to the FDAs in other countries like the United States.  

As the agency struggles to get through the backlog of approvals and pick up the pace, Cho says foreign pharma is increasingly frustrated. “I think the sudden change of practice is making the lives of our R&D people and regulatory people on the ground and at headquarters frustrating. A lot of investments are being affected by these uncertainties here in China.”

Illustration by Nicolet Schenck

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