AusBiotech has provided an online response to the Medicines and Medical Devices (MMD) First Report Stakeholder forum, which considered the review of medicines and medical devices regulation.
In early August, AusBiotech represented the industry at the three invitation-only forums that focussed on medicines, medical devices and unapproved products, and the practical implications of the approach proposed by the first report of the Review.
A call for comments from AusBiotech members on the Stage One Report helped inform the online submission that provided additional feedback to the Medical Devices Forum.
Overall, the Review’s first report has been well received by industry and is viewed as positive overall. AusBiotech and its members have expressed qualified support for the expedited pathway for assessment of novel medical devices for inclusion on the ARTG.
AusBiotech cautioned that, by their very nature, novel products are less well understood and therefore potentially pose a greater risk to public health than devices known to the TGA.
One approach that may minimise the risk to the public is to ensure that innovators accessing the expedited approval path are identified early and supported through the regulatory process. In some cases, it may be possible to transfer some of the regulatory oversight to the post-market domain (e.g. through post-market clinical studies and monitoring).
AusBiotech recommended that the Department of Health consider an assessment of the benefits of post-market monitoring across all three approval pathways as part of its current focus on the accelerated pathway.
A proposed move by the Review Panel to delegate the approval of devices to an ‘Advisory Committee’ could slow the process and therefore mean that the proposed ‘accelerated pathway’ is no better than alternate pathways, depending on the final outcome. This would obviously reduce its uptake.
AusBiotech is not convinced of the need for this recommendation and is concerned that it may be have unnecessary consequences. The proposal to establish an Advisory Committee on Medical Devices ought to be given further serious consideration before proceeding.
AusBiotech supports the general thrust of the report to provide as much flexibility and access to third party review as possible.
AusBiotech also expressed the concern of members over the focus on one particular recommendation, and ‘minor’ Pathway 3 in isolation from the primary Pathways 1 and 2 that have the bulk of activity.
Further comments from AusBiotech members can be addressed to National Programs Manager, Dr Mick Blake (mblake@ausbiotech.org) or Chief Industry Affairs Officer, Lorraine Chiroiu (lchiroiu@ausbiotech.org).