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Cost recovery implementation statement: Blood, blood components and biologicals (human cell and tissue therapies), From 1 July 2015
Version 1.0, July 2015
Reform of business processes
The TGA has continued to work on a series of reforms to improve understanding of the regulatory processes by its stakeholders; significantly enhance post-market and surveillance capabilities and enhance public trust in the safety and quality of therapeutic goods. For blood, and biologicals, these reforms aim to:
- Provide more information on the regulatory framework so that stakeholders understand regulatory processes and requirements
- Improve the usability, accuracy and consistency of guidelines
- Improve the management of adverse event reporting in support of consumer safety
- Promote the distribution of therapeutic goods safety information so that consumers are alert to warning signals
- Align recall procedures including communication of alerts to the public and health professionals
- Develop technology to support business processes
The TGA reports to stakeholders at six monthly intervals on our progress in delivery against a set of agreed performance reporting KPIs. The KPIs have been endorsed by the Australian Therapeutic Goods Advisory Council following consultation with the TGA-Industry Consultative Committee. For more information on the TGA's KPIs please visit TGA key performance indicators.
The KPIs are high-level indicators for the TGA's overall performance against our broad strategic intent. Within that matrix of KPIs is a requirement for measuring whether 'business operations are consistent and meet agreed service and timeliness standards'. Measures of specific business activities will continue to be documented in our half-yearly performance reports.
These reports are provided to members of the TGA-Industry Consultative Committee to enable us to report on specific parameters of relevance to industry stakeholders and to enable stakeholders to provide performance feedback. They provide detailed quantitative information about our performance on the timeliness of business activities as well as information for industry about the volumes of work performed by the TGA.