John Balzano is quoted in a BioWorld MedTech article regarding the decision by Chinese regulators to accept data from clinical trials conducted outside China for approvals of new drugs and medical devices. “In general, this statement is part of a long-term effort by the government and the China Food and Drug Administration that has been ongoing since 2015 to build a more efficient system of device regulation,” says Balzano. “From the types of documents that have come out, it is fairly clear that China’s priorities are encouraging innovation and meeting unmet medical needs, as well as ensuring that reviews of device applications happen in a more timely manner.” He adds, “It is unclear at this point how this system of accepting foreign data will work for devices, including what the criteria will be. It is difficult to determine how much of an impact this will make on the number of foreign devices approved and the timeline of a device application, which can be over a year.”
“[The CFDA] has established clinical trial exemption catalogues that can permit certain included devices to be approved in China without a trial, and it has seen the passage of an amendment to the device framework regulation earlier this year that should permit an easier accreditation process for medical device trial sites,” says Balzano. “It will take time to determine how these new structures work in practice and whether they are having the effect of encouraging innovation. Much of that will depend on the concrete details of implementation.”
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