TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments); or to share such work with comparable regulators to advance applications submitted in parallel.
In terms of which foreign regulators might be used, TGA says it’s currently anticipating that only those participating in the International Medical Device Regulators Forum (IMDRF), (ie. members of the management committee) would be evaluated. But for possible work-sharing agreements, TGA says it will evaluate regulators on an application-by-application basis.
Background
Currently, TGA, an active participant in IMDRF, may use assessments by overseas regulators or the bodies they designate in two ways: For conformity assessments, meaning a TGA assessment can be abridged if evidence of an assessment by an overseas regulator is submitted in support of the application (though TGA reserves the right to conduct a full assessment if it is not fully satisfied with the evidence provided), and by permitting the use of certificates issued by notified bodies located in the EU.
In practice, TGA says, EU notified bodies’ EC certificates support more than 90% of existing ARTG entries. But there are differences between Australian and EU device requirements, particularly as some devices are classified differently.
TGA notes, “Differences between Australian and overseas regulatory requirements, difference in the time when the medical device was assessed (potentially there can be significant changes in a device if some time has elapsed between the overseas and Australian assessments), post-market data including records of adverse events, and different expectations regarding safety of medical devices in Australia and overseas may result in rejection of an application for pre-market approval of a medical device even though it has been approved overseas.”
Criteria to Determine Comparable Regulators
A couple critical keys that TGA will need to consider before moving forward, according to the consultation, are: How large of a gap there is between the overseas approval and the additional information required by TGA to establish compliance within its regulations, and ensuring pre-submission discussions with other regulators if work-sharing agreements are forged.
“Criteria for assessing the comparability of an overseas regulator would be the same, whether for use of overseas approvals to support inclusion in the ARTG or work-sharing, although their application for different jurisdictions may vary. For example the information and assurance to support use of overseas approvals to support inclusion in the ARTG may be in place for a particular regulator, but that regulator may be unwilling to participate in work-sharing arrangements,” TGA says.
As far as the scope of such a framework, TGA offers the following questions: “Does the overseas regulator take into account the same or similar regulatory objectives and other factors that are prescribed in the TGA’s legislation and regulations (e.g. is the definition of a medical device substantially the same)? Does it take into account objectives that are excluded in the Australian legislation, for example additional policy objectives such as industry development or environmental protection? Does the overseas regulator provide complete (un-redacted) reports and is supporting scientific data used in assessments available if necessary?”
TGA also must consider whether an overseas regulator has a regulatory framework that applies across the life cycle of devices and has an approach for postmarket vigilance. TGA also considers whether the overseas regulator has experience in conducting product evaluations and quality management system assessments.
Depending on the outcome of this consultation and the passage of legislation, TGA says regulatory amendments will be developed sometime this year and are scheduled to take effect 1 January 2018.
Those interested in commenting on the consultation have until 30 June 2017.
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