Foreign companies seeking to market novel medical technologies in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape.
Under the agreement, the China Food and Drug Administration will accelerate reforms of its regulatory review and approval system, including eliminating a device approval backlog within two to three years. The agreement was announced last month at the conclusion of the U.S.-China Joint Commission on Commerce and Trade meeting in Chicago.
Excessively long timelines for getting innovative drugs to market in China is problematic for devicemakers and deprives Chinese patients of important healthcare options and benefits, the U.S.-China Business Council says. According to industry sources, it has taken some companies as long as eight years to get their products on the market.
The trade deal should ease entry for all foreign devicemakers, not just those in the U.S.
Among the expected reforms are measures to allow experimental devices to be tested in China while they undergo clinical study in other countries, which should shorten the device’s time to market, and clinical trial waivers for applications based on multiregional studies that include data from China, provided the applications comply with technical review requirements.
Negotiators also agreed on language reinforcing plans to expand the list of devices that are exempt from clinical trials in China if they are substantially equivalent to a predicate device — much like the U.S. 510(k) premarket pathway.
AdvaMed praised the deal, saying it would speed products to market strengthening regulatory systems to ensure safety and efficacy.
According to the U.S. Department of Commerce, U.S. companies exported more than $2.7 billion worth of medical devices to China in 2013. — Jonathon Shacat