China may relax trial requirements for new drugs, allowing foreign data

The CFDA says drug and device quality falls short of top international levels.

China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices.

It’s the latest in a string of regulatory initiatives implemented by Chinese authorities that could be a boost for international biopharma companies as well as Chinese patients, who sometimes have to wait six or seven years after launch in Western markets for drugs to be launched in China, according to a Reuters report.

The country’s huge and increasingly affluent population is facing an ever-growing burden of chronic diseases like cancer and diabetes, and the government has been under pressure to improve access to healthcare and new medicines. The latest wide-ranging set of proposals (in Chinese)—announced yesterday—recognizes that China is lagging behind other countries when it comes to approving new drugs. It’s approved 100 innovative new drugs in the last five years, around a third the number in developed markets.

China is in the midst of a big overhaul of its regulatory regimes governing healthcare products, reforming rules covering the development and manufacturing of drugs to bring the country closer in line with international standards. Earlier this year, for example, it pledged to do away with a ponderous certification system for clinical trial sites in a bid to encourage domestic clinical research. At the same time, it said it would adopt a “no response within 60 days means approval” approach to clinical trial applications, similar to the 30-day system used by the U.S. FDA.  

The China Food and Drug Administration (CFDA) suggested at the time that admitting foreign clinical data could be in the cards. As it stands, CFDA now requires phase 3 trials of at least 200 patients for chemical drugs and 300 patients for biologics, but the new measures would allow data from overseas patients to count toward that tally.

The CFDA has, however, been criticized for allowing a big backlog of pharmaceutical marketing and clinical trial applications to grow, and implementing a scheme to encourage new drug filings will likely only exacerbate that problem in the near term. And the new proposals don’t include a timeline for implementation.

China’s pharmaceutical market, which reached $108 billion last year, is now the second-largest in the world, according to BMI Research, and is predicted to reach nearly $118 billion this year despite the braking effect of imposed rice reductions. In July, the Chinese government added 36 new drugs to the National Drug Reimbursement List, implementing price controls on a raft of drugs used in pediatrics, cancer, hepatitis and renal and cardiovascular disease.