Rumors: SFDA to Speed INDs / US FDA OK with China Data

publication date: Sep 29, 2007

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author/source: Greg B. Scott

This definitely falls into the rumor category, but we have both of these items on good authority, so we believe they are true.  But time will tell.

First, the SFDA is announcing on October 1 that it will shorten the IND approval time from the current eight to twelve months, to a target of four months.  As you know, the SFDA is still in disarray since the execution of the former head of the SFDA and the imprisonment of several of his chiefs for bribery.  We've been hearing that even twelve months has been optomistic for most approvals.  This has slowed the entry of drugs into trials, and even the number of IND applications is said to have slowed, as companies look elsewhere for faster progress. 

But the SFDA has recognized that it must improve this or risk sabotaging its own objectives of becoming a world leader in drug development by 2010.  So, once again it appears to be ready to take swift action to correct the problem, and break the log jam in its clinical trial process.

The second rumor has to do with using China-only data to file for IND in the U.S.  To our knowledge, there is no precedent for this, although there has been some use of China data as an adjunct to U.S. data, which the FDA has accepted.  The FDA has also accepted China data, but required some tests to be re-performed in the U.S.  We are being told that, for the first time, a company has filed for an IND using all-China data and that the FDA has stated that it is prepared to accept this. 

If this is the case, this will open up the use of China-based CROs to perform all of the pre-clincial studies for U.S.-bound drugs, saving them 70% to 80% of the costs of doing the studies in the West.  Unfortunately there are only a few CROs in China capable of producing FDA-quality data at this point, with the best know including BioDuro, Bridge and HD Biosciences.  But others will likely ramp up quickly once there is a demand.

The next logical step will be for the FDA to allow all-China data for clinical trials.  This will be a huge boon for U.S. biopharmaceutical companies, not only in cost savings, but in speed.  It is significantly easier and quicker to recruit patients in China, and there are also a much larger population of naive patients to draw from.  We've heard of trials of thousands of patients being completed in 12 to 18 months.

BioDuro and Fountain Medical are rapidly establishing clinical trial facilities and services to position themselves for the expected growth as U.S. biopharmaceutical companies gain confidence in the use of China data for their trials.

These two events - the reduced time to SFDA IND approvals, and the acceptance of China study data by the FDA - would be huge steps in propelling China's biotech industry forward in the next few years.

See other articles on China CROs.