TGA Releases Self-Assessment July-June 2018

21 December 2018 | Grant Bennett | Chief Executive Officer


As a final gift to members of the regulatory profession (or anyone who has an interest in bringing product to the Australian market), the Therapeutic Goods Administration (TGA) announced the release of their 2017-2018 Regulator Performance Framework Self-assessment Report in the last week of December.

The framework for these KPI’s has been developed by the Australian Government to measure the ongoing performance of the TGA. The Framework comprises six key performance indicators (KPIs) summarised below:

1. Regulators do not unnecessarily impede the efficient operation of regulated entities
2. Communication with regulated entities is clear, targeted and effective
3. Actions undertaken by regulators are proportionate to the regulatory risk being managed
4. Compliance and monitoring approaches are streamlined and coordinated
5. Regulators are open and transparent in their dealings with regulated entities
6. Regulators actively contribute to the continuous improvement of regulatory frameworks.

Through the 2017-2018 period, the report indicates that overall, the agency was successful in meeting their KPIs. In one instance, being that of the regulator being open and transparent in dealing with their regulated entities, it was indicated that this was substantially met where there was some concern raised around the change in operating procedures for handling external enquiries had led to reduced clarity. In all other cases, the KPI was met. What is evident throughout the report, is the agency has stepped up its awareness programs for both industry and consumers through regular consultations, workshops, webinars and improvements to the website. As education continues, the industry can expect an increase in its compliance requirements into the future. We’ve already been seeing this through increase post market and marketing surveillance.

Whether you agree with the results from the assessment or not, what is clear, is that the regulator is engaging closely with industry and are continuing to identify ways to improve their services.

If you need support with any of your regulatory needs, be sure to reach out to us for an obligation free discussion.

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