Therapeutic Goods Administration - new structural arrangements

28 June 2010

The Therapeutic Goods Administration (TGA) will officially launch a new organisational structure on 1 July 2010. This new structure will support the TGA's delivery of appropriate, consistent, effective and efficient regulation into the future.

This is the first time the TGA has comprehensively reviewed and implemented changes to the organisation of its services since it was established in 1989. Over this time the TGA has developed a robust regulatory framework, well-suited to the products regulated. However, in the face of rapid industry evolution, the TGA, along with most international regulators, must adapt to meet the challenges of the 21st Century.

The TGA's offices will be arranged in three groups, based on their area of regulatory oversight:

• Market Authorisation Group;
• Monitoring and Compliance Group; and
• Regulatory Support Group.

The new structure has been designed to ensure that the TGA continues to fulfil its public health mandate of safeguarding public health through the effective and timely regulation of therapeutic products.

This approach will ensure seamless interaction between our different regulatory streams, providing the opportunity for the TGA to build upon existing knowledge, while also improving cohesiveness of regulatory activity across the organisation.

An opportunity created by this restructure will be the ability to reduce duplication of common services, supported by a more strategic approach to the use of information technology to support the regulatory operation.

The TGA has already implemented several reforms aimed at enhancing the transparency of regulatory decision making. Notably, the publication of Australian Public Assessment reports (AusPARS), detailing the risk benefit analysis undertaken by the TGA in deciding to regulate new prescription medicines. Similarly, since November 2009 the TGA has published Product Information and Consumer Medicines Information on its Internet site.

The implementation of the new structure is being carefully managed to ensure that current regulatory services are maintained, and you should notice no significant impact on your access to the TGA's business systems and regulatory services during the transition to the new structure.

Importantly, the TGA's main contact points will remain as they are at this time. Please continue to liaise with your current TGA contacts for any day-to-day business needs.