AusBiotech response to Review of Medicines and Medical Devices Regulat
1 Sep 2015
AusBiotech has provided an online response to the Medicines and Medical Devices (MMD) First Report Stakeholder forum, which discussed 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 on 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 and a welcome approach in most aspects. 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 do devices that are 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 Federal Department of Health include in the current focus on the accelerated pathway, an assessment of the benefits of post-market monitoring across all three approval pathways.
A proposed move by the Review Panel to delegate the approval of devices to an 'Advisory Committee', depending on the finer detail of this aspect, may slow the process and therefore mean that the proposed 'accelerated pathway' is no better than alternate pathways. This would obviously reduce the uptake of the service. AusBiotech is unconvinced of the need for this recommendation and benefits that might be derived from it, and is concerned that it may be have unnecessary detriments. 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 which is consistent with acceptable standards of rigour of review.
AusBiotech also expressed members’ concern regarding 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).