TGA Regulatory Business Plan 2019-2020

Business plan

The TGA Business Plan is updated annually and is a central part of their activity planning and performance monitoring framework.

Late September has seen the Australian regulator, the Therapeutic Goods Administration, release their Business Plan for 2019-2020.

The plan outlines the year’s objectives and key areas the Australian regulator will be focusing on. Not surprisingly and aligning with many of the global agencies, there is a growing focus not only on the post market requirements but also stakeholder engagement.

As outlined in this detailed paper, the following Priorities are key:

  1. Product regulation and safety – through our core regulatory activity and business process improvements.
  2. Regulatory reform – including activities associated with the continued implementation of recommendations from the Review of Medicines and Medical Devices Regulation.
  3. International engagement – through activities associated with the promotion of international work sharing and regulatory convergence, as well as programs for regulatory strengthening and provision of medicines testing services in our region.
  4. Regulatory education and compliance – through education, monitoring, targeted compliance and enforcement activities and appropriate action.

As many within industry would be aware, the focus for the regulator is ensuring that all Australians have access to safe and effective products, whilst understanding that no products are without risk. Having a regulator understanding this, while being able to apply this understanding to the regulatory review cycle are two very different challenging areas and one that in some instances has been a challenge to balance.

What is evident throughout the report is that the TGA is looking to increase consumer awareness of product requirements. As can be expected, this ultimately equates to an increase in post market activities for manufacturers and importers, again increasing the resource demand on what is already a stretched requirement within industry.

All in all, providing a report such as this to stakeholders does provide a clearer understanding specifically within industry on what we can expect in the future.

If you’ve any questions on this, please be sure to reach out for a no obligation discussion on how the TGA’s approach may impact you.

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)


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