Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need.
The 2014 Decree 650 reforms in China dramatically tightened CFDA’s regulatory controls. Most controversially, China moved to require all devices not specifically exempted to be supported by direct clinical trials in China unless the manufacturer could show equivalence to already approved devices. The standards for equivalence were set so high that in practical terms it’s only possible to demonstrate equivalence to an already approved earlier variant of the device from the same manufacturer.
In May 2017, a series of announcements CFDA suggested the pendulum has started to swing backwards.
CFDA first announced a “Third wave” of exemptions for Class II and III medical devices. This was followed by publication of the first separate list of 130 IVDs exempted from clinical studies in China.
Then CFDA published draft policy documents Circulars 52 and 53 which if implemented could dramatically streamline clinical evaluation for some devices.
Practice Updates and More Audits
Circular 53 addresses the present practices for clinical trials in China. There are proposed adjustments to ethics processes including moving to a lead site primary ethics review with other sites accepting the findings without a second review. This is similar to a model successfully trialed in Australia and the US in recent years.
Another significant change is that CFDA is proposing to abolish certification requirements for clinical study facilities. This has always been a tricky area, not least in that CFDA has never published a list of approved device trial centers but instead relied on the approved list of pharma sites! IF adopted, in future a notification to the CFDA will allow clinical institutes to conduct a clinical study if they meet objective criteria(yet to be specified).
CFDA is also proposing to conduct more on-site audits of clinical study projects – with studies failing audits leading to registration refusals where applications are supported by the study.
Most importantly, Circular 53 proposes that CFDA accept international clinical data which has been used to support regulatory approvals outside of China. There are two caveats though. First the trial must pass an on site CFDA audit – so it’s difficult to see how historical data could be used. Second is the proviso that the manufacturer must show these data are applicable to the Chinese population – which may be too big a barrier for many, but at least the door has been cracked open.
Postmarket Clinical Follow Up
The concept of expediting devices which meet urgent clinical need by allowing postmarket follow up is gaining favour in China. This practice is well established in major western markets and now in China, CFDA’s Circular 52 proposes a form of conditional registration contingent on postmarket trials being reported to CFDA later in order to convert to full registration.
Yet again China has picked what it sees as useful international practices and seeks to apply them in a uniquely Chinese context. The consultations have already closed – it remains to be seen how far these reforms will go.
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