On this page: a) Annual charges exemption scheme | b) Review of medicines and medical devices regulation

a) Annual charges exemption scheme

The annual charges exemption (ACE) scheme replaced the low value turnover (LVT) scheme on 1 July 2015 following a review of the operation of the LVT which included a public consultation and Regulatory Impact Statement.

The ACE scheme is more equitable, reduces red tape for business and provides administrative efficiencies for the TGA. It recognises that TGA's post-market monitoring costs are incurred for products that have been placed into the market and allows sponsors to enter their products in the ARTG in advance of their marketing with no annual charge (until turnover commences). For more information on the ACE please visit: Annual charge exemption scheme.

When the ACE scheme was introduced the TGA undertook to monitor the impact of the new scheme on the therapeutic goods industry. In December 2015 a preliminary assessment of the financial impact of the ACE scheme on industry sponsors across a range of business areas showed, at that point in time, a forecast increase of $2.5 million or 5 per cent in annual charges in 2015-16 under the ACE scheme. The preliminary assessment report is available on the TGA website.

At the time of undertaking the preliminary assessment the ACE scheme had been in operation for only a few months (July 2015 to October 2015), and the full impact and effectiveness of the ACE scheme will not be known until it has been in operation for a minimum of 2 years. The impact of the introduction of the ACE scheme will continue to be monitored as the scheme matures and changes will be made, as required, to ensure appropriate cost recovery for each sector.

b) Review of medicines and medical devices regulation

An independent review of medicines and medical devices regulation was announced on 24 October 2014. The aim of the review 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.

In its two staged report (stage 1 released on 31 March 2015 and stage 2 released on 31 July 2015), the review panel provided the Government with 58 recommendations. In summary, the report recommended:

• 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 for products in the ARTG;
• improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products;
• expanding the pathways by which sponsors can approve an ingredient for use in a listed medicine, and for marketing approval of a listed complementary medicine;
• enhancing the transparency and predictability of processes and evidence requirements associated with ingredient approvals and complementary medicine marketing approvals;
• improving and clarifying the interface and synergies between the market approval of therapeutic goods and advertising requirements that ensure consumer protections are balanced with the availability of information for consumers and health professionals to make informed spending and health decisions; and
• enhancing and streamlining the advertising framework to facilitate and maximise compliance and the management of complaints.

In 2016-17 the TGA will manage a comprehensive reform agenda based on the 2016-17 Budget measure "improving the Regulation of Therapeutic goods in Australia".