Newsroom.

AusBiotech, last week, represented the industry at invitation-only forums, held by the Deregulation Branch of the Federal Department of Health to discuss the first report on the review of medicines and medical devices regulation, which was released on 31 March 2015.

The Review, conducted by an independent Expert Panel, makes 32 recommendations in its first report covering six main areas:

Principles for regulation;

1. Pre-market approvals;
2. Post-market monitoring;
3. Access to unapproved therapeutic goods;
4. Structure; and
5. Broader reviews

The recommendations include:

• Expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances;
• Identifying comparable overseas regulators using transparent criteria;
• Enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements in respect of products in the Australian Register of Therapeutic Goods; and
• Improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products.

The three forums – medicines, medical devices and unapproved products - were held to provide an opportunity for feedback from stakeholders and to discuss the practical implications of the proposed approach.

The full report can be found at:
Review of Medicines and Medical Devices Stage One Report 

The aim of the Expert Review (announced in October 2014) was to examine the TGA's regulatory framework and processes with a view to identifying: Areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and Opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

Comments from AusBiotech members on the Stage One Report can be addressed to National Programs Manager, Dr Mick Blake (mblake@ausbiotech.org) or Chief Industry Affairs Officer, Lorraine Chiroiu (lchiroiu@ausbiotech.org).