Big Pharma, rejoice: China aims to speed up approvals for new meds

Print 19 August 2015
Emily Wasserman / FiercePharma

Relations between China and foreign drugmakers have been thawing for a while, with the country announcing late last year that it would toss out restrictive price caps and streamline drug approvals for U.S. companies. Now, China is throwing multinational drugmakers another bone with plans to reduce lengthy approval times for innovative drugs.

Companies can now apply to speed up approvals for much-needed new meds--including those for AIDS, cancer and rare illnesses--as long as their prices aren't higher in China than in the originating country or comparable markets, according to guidelines set out by China's State Council seen by Bloomberg. The country is also loosening its belt on clinical trial regulations for new drugs. Under the new policy, foreign companies can run clinical trials in China at the same time as overseas trials, and use data from international clinical trials to apply to bring their meds into the country.

That's a big win for multinational companies, which once had to jump through more hoops to bring their meds to market. In the past, foreign companies could only apply to import a drug to China after it had been approved and marketed in another country, the Bloomberg article notes. And drugmakers also had to run trials on Chinese patients before they got a marketing OK.

The move comes as welcome news to foreign drugmakers, which have struggled to get their meds approved in the country. China's restrictive approval process has resulted in a backlog of new drug applications, with 21,000 awaiting review and approval with a staff of just 120 to sift through them, Wu Zhen, vice minister of the China Food and Drug Administration, told the news outlet.

But the country wants to reverse that trend, shooting to eliminate its backlog of drug applications by the end of 2016, according to guidelines seen byBloomberg. "Our attitude is very clear, we welcome innovative drugs to China, to come early, the sooner the better," Zhen said, according to Bloomberg.

Still, multinational companies could face an uphill battle as they bring their drugs to market. Growth in China's pharma market "slowed meaningfully" in Q2, Bernstein analyst Tim Anderson said earlier this month, falling to 4.6% growth from 15.1% in Q1. Companies have blamed the slowdown on everything from government cost cuts to restrictive policies toward volume growth. But a shift to lower-priced--typically local--generics could also be taking its toll, Anderson wrote in a note to clients.

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