China proposes new FDA rules to speed up foreign drug approvals

CFDA
China's FDA proposed major changes to its current foreign drug registration regulations, including less restrictive requirements for data submitted for new drug approvals.

China's FDA published (Chinese) a slate of suggested amendments to its foreign drug registration rules Friday, which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes.

Gone was the requirement that foreign drugmakers can only apply to start clinical trials for a drug—except for vaccines—in China after it has at least entered phase 2 testing elsewhere.

Perhaps more dramatically, the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs.

The proposed changes, just a few hundred words long, directly tackle the clinical trial requirements foreign pharmas have found too restrictive, and the companies soon moved to show their support.

“When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines,” Pfizer said in a statement to FiercePharma. “They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development.”   

Now it’s clear that when China’s FDA director Bi Jingquan promised to speed up foreign drug approvals in China a few days ago during the country’s annual congress sessions, the agency already had its plans sketched out. But why would these changes mean so much for foreign pharmas?

RELATED: China pledges to speed up approvals of foreign drugs

Previously, foreign drugs had essentially two routes to Chinese approval. One, come to China after the drug has been approved elsewhere and then conduct China-specific trials. Companies could ask for exemptions from domestic trial requirements if previous trials included large groups of Asian patients—something that's been difficult to achieve historically.

Two, use China as part of multicenter clinical trials after the drug has at least been tested through phase 1 elsewhere—potentially beginning with phase 1 all over again.

The problem with the first route is quite obvious: Marketing the drug in China has to wait until a drug goes through late-stage trials and regulatory review elsewhere, plus the arduous approval process in China, which by itself can take years to complete.

Even so, many foreign pharmas have preferred the first route, because including China in a global development project could seriously delay an EU or U.S. filing. Again, the widely criticized and slow regulatory process in China was to blame; bringing China trial sites online requires CFDA approval.

What’s more important—in what was seen as a twist to CFDA’s interpretation of its own regulations and a serious turndown for foreign pharmas—beginning in 2014, data from multicenter trials, even when China was included as a trial site, could not be directly used for a new drug application in the country. Instead, drugmakers still needed to go through clinical trial applications, though not clinical trials themselves.

Now these barriers are very likely to be removed. Together with Bi’s previous promise to speed up approval processes by hiring more staff at CFDA’s Center for Drug Evaluation and revamping the agency’s workflow, this means innovative foreign drugs could debut in China more quickly than before. And that doesn't just mean accessibility to new drugs for Chinese patients, but also means less effort and lower costs for foreign drugmakers eager to bring their meds to the fast-growing market.

Several foreign pharmas have enjoyed promising growths in China in recent years. AstraZeneca, for example, reported 10% sales growth at constant exchange rate in the country to more than $2.6 billion in 2016. It continues to build on a JV between its MedImmune unit and CRO WuXi AppTec to develop and commercialize in China a treatment for autoimmune and inflammatory diseases. The IL-6 monoclonal antibody, dubbed MEDI5117 (WBP216), in January just gained (Chinese) a CFDA approval to start phase 1 trials. Novo Nordisk’s sales in the country grew about 5.9% in 2016 to more than 10 billion Danish krones ($1.5 billion). 

The agency is soliciting public opinion for the new rule until April 20. If the proposals are approved, it’ll then be up to foreign pharmas to readjust their research and marketing strategies in China.

Editor's Note: The story has been updated to include a statement from Pfizer and corrected 2016 Chinese sales numbers from several pharma companies.