AusBiotech advocates post-market monitoring in review of medicines and medical device regulation,

AusBiotech, the representative body for the Australian biotech industry, has responded to the Medicines and Medical Devices (MMD) stakeholder forum, discussing the review of medicines and medical devices regulation.

The review’s first report has been well-received by the industry and is generally seen as positive in most regards. AusBiotech warned that by their nature novel products are less well-understood and therefore a greater potential risk to public health than devices known to the Therapeutic Goods Administration (TGA).

It proposed early identification of innovators accessing the expedited approval path and supporting them through the regulatory process as a way to lower the public health risk. AusBiotech also suggested it could be possible to transfer some regulatory oversight to the post-market domain. It recommends that the Department of Health include an assessment of the benefits of post-market monitoring across all three current approval pathways.