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Regulator Performance Framework: Self-assessment Report, July 2018 to June 2019

2018-19 Performance Reporting

20 December 2019

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KPI 4 - Compliance and monitoring approaches are streamlined and co-ordinated

Measures/metrics Evidence (performance in 2018-19)

KPI 4.1

Regulators' information requests are tailored and only made when necessary to secure regulatory objectives, and only then in a way that minimises impact.

We performed a review of regulatory letter templates during the period, amending them to provide clearer articulation of regulatory requirements, decisions, and the reasons behind the decision.

We also participate in the Medical Devices Single Audit Program, which allows agencies from Australia, Brazil, USA, Canada and Japan to collaborate and provide oversight without additional onus on industry.

Self‑assessed rating: Met

KPI 4.2

Regulators' frequency of information collection is minimised and coordinated with similar processes including those of other regulators so that, as far as possible, information is only requested once.

Whenever possible, we complement information from sponsors with information already gathered by other regulators, such as our international counterparts. One joint GMP inspection was conducted during this period, and there were four occasions where the TGA observed an international regulator on inspection to facilitate information sharing.

We undertake desktop GMP clearances for overseas manufacturers, with consideration of decisions made by comparable regulators, and share manufacturing inspection schedules with our international counterparts.

The TGA is part of an international work-sharing initiative involving Australia, Canada, Singapore and Switzerland (the ACSS Consortium). We work collaboratively through a joint-review of new active substances (chemical or biological entities). This partnership incentivises early registration of new medicines within Australia and benefits the community by improving timely access to the most recent and innovative treatment options. The ACSS partnership maximises the use of up to date international technical expertise, and ensures a consistent, contemporary approach to assessing the benefits and risks associated with the use of new medicines. This brings greater alignment of regulatory approaches, technical requirements and better use of resources, which reduces duplication and improves efficiency.

Self‑assessed rating: Met

KPI 4.3

Regulators utilise existing information to limit the reliance on requests from regulated entities and share the information among other regulators, where possible.

Wherever possible we share information with our international counterparts, and with state and territory health departments. We are also members of several forums and working groups dedicated to identifying opportunities for collaboration and increasing international synergy.

Reporting of medicine shortages was made mandatory as of 1 January 2019 to better support health professionals and assist patient care, based on the recommendations of a working group formed of sponsors, stakeholders and medical professionals.

The TGA continues to be a member of the International Medical Device Regulators Forum National Competent Authorities Report, a program that allows us to provide and receive knowledge with other regulators. For example, we have undertaken regular meetings with international regulators, states and territories, and expert working groups on breast implants and ventilators.

We continue to work with the Food Standards Australia New Zealand (FSANZ), Customs, the Australian Government Department of Agriculture, the Australian Federal Police and relevant state and territory agencies as appropriate when it is necessary to decide whether products are regulated as food or as therapeutic goods (food-medicine interface).

Self‑assessed rating: Met

KPI 4.4

Regulators base monitoring and inspection approaches on risk and, where possible, take into account the circumstance and operational needs of the regulated entity.

Our processes have been developed to ensure as little impact as possible on regulated entities during the monitoring and inspection process. The inspection timeline in based on a risk approach unless it has been identified that there may be issues with a specific facility that requires attention at a time earlier than the normal inspection calendar. Furthermore, in some cases we forgo an inspection due to our desktop assessment program.

During the period we conducted total of 264 inspections (189 domestic and 75 international) of regulated entities. 85% of international inspections received a satisfactory compliance on inspection, and 80% of domestic inspections. Further details on the GMP Inspection Program are available in the 2018-19 Annual Performance Statistics Report.

We also conducted 69 on-site audits (35 domestic and 34 international) of medical device manufacturers. 100% of international audits received a satisfactory compliance rating, while the rate was 93% for domestic audits.

We finalised 3,271 compliance cases in the reporting period, including issuing 2,489 warning letters, 9 infringement notices and 1 criminal prosecution.

Self‑assessed rating: Met

External validators agreed that we provided a coordinated approach to compliance and monitoring, and unanimously endorsed our self-assessed rating of 'met'. They also noted that our partnerships with overseas regulators, and our involvement with the Australia, Canada, Singapore and Switzerland consortium, reduced duplication and improved our efficiency as a regulator. Feedback included some suggested areas of focus for future streamlining opportunities.

Identified opportunities for improvement

Collaboration and international alignment are ongoing activities centred around continuous development, with additional countries being assessed for inclusion in our list of comparable overseas regulators. We will continue to consult with stakeholders to identify areas for improvement.

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