The Australian Government Release a Blueprint for TGA’s Future – How Does This Affect Your Organisation?

The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. The reforms are designed to improve the transparency and efficiency of therapeutic goods regulation and will affect almost all manufacturers and sponsors of therapeutic goods in Australia.

The government’s blueprint includes the following:

• Plans to focus on improving communication and engagement with the community with the intention of becoming a well known and understood regulatory agency.
• Plans to establish an Australian Therapeutic Goods Advisory Council which will facilitate direct public feedback and comment on TGA activities
• An intention to improve current arrangements for the regulation of therapeutic goods advertising by creating a central point for all complaints about advertising, and the development of options for further consideration.
• A plan to update and include in the regulation of complementary medicines the ‘guidelines for the levels and kinds of evidence to support indications and claims’ to increase rate of compliance with regulatory and legislative requirements.
• Medical device reforms including increased rigour of pre-market regulatory assessment of high risk devices, reclassification of load bearing joint replacements (from Class IIb to Class III), a requirement that Australian Register for Therapeutic Goods (ARTG) inclusions to specify all devices sold under each ‘kind of medical device’ inclusions, and an increase in the product information available on the TGA website.
• A commitment to maintain an emphasis on self-regulation of industry in relation to promotion of therapeutic goods.
• An indication that a modest increase in fees will apply to implement the fundamental reforms.

Whilst reforms are welcomed, there appears to be some disappointment in the failure to implement reforms to create equality in the promotion of therapeutic goods. Based on the government’s current stance, a level playing field appears somewhat out of reach for industry. It has also been said that an increase in fees is likely to be not well received by sponsors and manufacturers in Australia, with current fees already considered to be significant for smaller companies.

For manufacturers and sponsors, the reality of the reforms is here, meaning it is time to prepare your organisation to comply with the requirements or implement plans to do so. For medical device reforms, transition periods apply however it is recommended that a focus on compliance within your organisation is actioned as soon as possible.

To better understand new requirements for your organisation and for guidance regarding the most effective way to comply,  contact KD&A.