China's hard-to-navigate drug approval system, slow processing and unfavorable intellectual protection environment have been major concerns of foreign biopharma companies, but top officials there have pledged to tackle those issues to draw more advanced foreign drugs into the market.
China is working on new measures to speed up its drug approval process, Bi Jingquan, director of China’s FDA said during comments to reporters broadcast on CCTV during the annual meetings of the country’s congress, currently in session.
He mentioned four problems—all of major concerns to foreign biopharma companies—that the agency, with the help of others, intend to improve.
In China, a foreign drug is only allowed to apply for initiating a clinical trial after it’s been tested through phase 1 abroad—but then could also be asked to go through phase 1 testing in China. Bi said this regulatory design unavoidably delays a new drug’s marketing in China.
“The system is not set up to accommodate international drugs in parallel or even near parallel development with their global timelines,” said Helen Chen, managing director and head of life sciences with L.E.K. Consulting’s China unit, in an emailed interview with FiercePharma. “The long CTA process means that including China in the global development process would likely delay an U.S. or EU filing, which companies are reluctant to do.”
The CFDA chief said that the agency is working to “eliminate unreasonable regulations.”
Intellectual property legislation is another barrier that has disheartened foreign biopharma companies, Bi said. But it is widely recognized that China’s IP legislation is in large part on par with its international counterparts—in all aspects from patent and trademark, to drug and trial data protection. As an emergent market relying predominantly on generics, the actual execution of those laws and regulations for innovative drugs is what foreign biopharma companies have always been worried about.
But to Chen’s interpretation, Bi’s comment is less about IPR directly, and more about a shorter remaining patent life caused by a late approval and launch in China. The drugs “may not enjoy as much exclusivity on the market before generics hit” because of delays in approval, Chen said.
That’s also related to two other problems Bi brought up during the press session—long approval process and outdated insurance reimbursement drug list.
The agency’s slow application processing capability has been a major complaint, not just from foreign companies but domestic ones as well. CFDA’s Center for Drug Evaluation is extremely understaffed, said Bi. Even after the agency increased the number of drug evaluation specialists to about 600 from a mere 120 during the past two years, that number is still far smaller compared with the U.S. CDE’s 5,000, he said.
But the agency has been making progress. The center has managed to reduce NDA cases’ waiting list from a peak of 22,000 in 2015 to about 8,000 last year, according to Bi.
Still, as pointed out by a congress member during the national meeting, it could take a foreign drug about 6 to 10 months before an CTA approval, a marketing authorization could take as long as 62 months, and even the shortest waiting period for that process is about 20 months.
Take GlaxoSmithKline’s HPV vaccine Cervarix for example. It was first approved in the U.S. in 2009, but it took the U.K. company until last July to get the drug approved in China. Then only a few months later, the drug was taken off the U.S. market due to “a very low market demand.” That caused domestic criticism over the CFDA's efficiency in approving foreign drugs.
In an effort to reduce those delays, Bi said the agency is looking to hire more staff, along with revamping its drug evaluation procedures.
At the same time, the agency has opened up its expedited drug review process for drugs “with significant therapeutic values.” That green channel saw 12 batches of drugs being fast-tracked for review in 2016. Some drug products by foreign companies such as Bristol-Myers Squibb, Roche, Novartis, Eli Lilly, Merck, Sanofi and Boehringer Ingelheim, benefited from that policy.
The country also just updated its National Reimbursement Drug List after about eight years. Some blockbusters like GSK’s Viread and AstraZeneca’s Iressa made the new roster. Even though inclusion in the list usually entails major price cuts, it also means a larger market in China and is seen as almost a guarantee for sales growth.
Editor's note: The story has been updated to clarify that a drug might be asked to--not must--redo phase 1 in China even after it has already gone through that phase abroad.