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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 1 - Regulators do not unnecessarily impede the efficient operation of regulated entities

Measures/metrics Evidence (performance in 2018-19)

KPI 1.1

Regulators demonstrate an understanding of the operating environment of the industry or organisation, or the circumstances of individuals and the current and emerging issues that affect the sector.

Ongoing engagement with industry provides opportunities for us to identify and assess issues, respond to emerging risks, and introduce change to stakeholders in a manner that does not impede their functions. In addition, it allows stakeholders to provide input on key areas of policy development throughout the process. In 2018‑19 we participated in over 70 formal stakeholder forums that included industry events, regulatory workshops for stakeholders and bilateral meetings with industry groups.

Highlights included:

  • The TGA Consultative Committee and TGA Industry Forum each meeting twice during this period. Attending stakeholders used the opportunity to have input into TGA activities and discuss regulatory activities and priorities.
  • Attending, presenting and receiving feedback from the bi-monthly Medicines Australia Regulatory Affairs Working Group meetings in addition to regular targeted consultation with the Generic and Biosimilar Medicines Association.
  • Hosting four meetings of the Regulatory and Technical Consultative Forum for Medical Devices to discuss issues of a regulatory and technical nature with industry.
  • The TGA held regular stakeholder advisory committee meetings throughout 2019. These included the Advisory Committee on Medical Devices (seven meetings), including a specialist orthopaedic meeting to review data issued by the National Joint Registry; the Advisory Committee on Medicines (six meetings) which provided independent advice to the Minister for Health and the TGA on issues relating to the safety, quality and efficacy of medicines supplied in Australia; and the Advisory Committee on Vaccines which provided independent advice relating to vaccines supplied in Australia and issues relating to safe use in national immunisation programs.
  • Meeting with the TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) and TIWGG Technical Working Groups. The meetings allowed members to provide feedback on Good Manufacturing Practice (GMP) service delivery in TGA and the adoption of PIC/S Guide PE009-13.
  • Establishing partnerships with SMEs including universities, industry organisations and state and federal government agencies to deliver workshops and information sessions tailored to those new to therapeutic goods regulation.
  • The TGA was an active participant in the annual conferences of industry bodies including Complementary Medicines Australia, Medical Technology Association of Australia, Medicines Australia, and AusBiotec Pty Ltd. Attending these annual conferences allows us to develop an understanding of current and future issues and priorities of the industry.

During 2018-19 the TGA became the single body responsible for handling complaints about the advertising of therapeutic goods to the public. A new Therapeutic Goods Advertising Code was implemented and a formal advertising education program instituted. The Therapeutic Goods Advertising Consultative Committee (TGACC) was formed to support these changes, with three meetings held in the reporting period. The TGACC brings together members from industry, health care professionals and practitioners, health organisations, media and advertisers and a varied group of consumer interests.

We also met with individual stakeholders, including Consumer Healthcare Products Australia, Complementary Medicines Australia, Accord Australasia, Medical Technology Association of Australia and Direct Selling Australia, to understand the implications of proposed changes to the advertising requirements on their constituents.

Self‑assessed rating: Met

KPI 1.2

Regulators take actions to minimise the potential for unintended negative impacts of regulatory activities on regulated entities or affected supplier industries and supply chains.

We continued to comply with the best practice regulation requirements. During 2018-19 the TGA sought advice from the Office of Best Practice Regulation (OBPR) on 21 occasions as to whether a Regulatory Impact Statement (RIS) would be required for proposed reforms.

The OBPR determined one RIS was required and the TGA is in the process of undertaking the appropriate level of consultation and analysis prior to completing the RIS.

Where the OBPR confirmed a RIS was not required, prior to introducing the reforms the TGA engaged with all potentially affected parties to explore opportunities for the best outcome.

We published 31 public consultations on the TGA website, giving regulated entities the opportunity to provide input on any potential for unintended negative impacts that were not considered prior to proposed implementation.

Significant consultations undertaken included:

  • Advertising code guidance
  • Reviewing the latest Pharmaceutical Inspection Co-operation Scheme Guide to GMP products for Medicinal Products (PIC/S Guide PE009-13 and PIC/S Guide PE009-14)
  • Good Clinical Practice (GCP) Inspections Pilot Program
  • Whether the TGA should publish that a prescription medicine is under evaluation
  • TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) and the Medicinal Cannabis Industry Association
  • Medical device reforms and action plan, including the proposed establishment of a Unique Device Identifier system, and the regulation of software as a medical device.

Self‑assessed rating: Met

KPI 1.3

Regulators implement continuous improvement strategies to reduce the costs of compliance for those they regulate.

New provisional and expedited approval pathways of medicines and devices introduced in 2017-18 were embedded and reviewed for efficacy and uptake. The TGA approved 19 prescription medicine registrations that were processed via the expedited pathways, and made a further nine provisional determinations and nine priority determinations for prescription medicines. Regarding medical devices, the TGA has made 1 conformity assessment (priority applicant) designation.

In April 2019 the TGA established a team to look at emerging medical device technology. The team is conducting regular webinars (both educational and reforms based) to keep industry and consumers informed of regulatory requirements for emerging technologies. Cybersecurity guidance was published to support industry and consumers.

Twelve advertising workshops were held for regulated entities about the new Therapeutic Goods Advertising Code. These were attended by approximately 400 industry representatives. Three webinars were held to support stakeholders unable to attend in person.

In our capacity as a WHO-designated Essential Regulatory Laboratory, we supplied influenza reagents to vaccine manufacturers worldwide. The TGA has now introduced an online ordering system to streamline the process for industry.

We commenced a review of the generic medicine market authorisation process. The review identified opportunities to reduce the costs of compliance for generic medicine sponsors by reducing regulatory barriers for applicants, making regulatory requirements clearer and more transparent, and reducing Australia-specific regulatory requirements. Public consultation on the proposed reforms was held in early 2019. Implementation of the proposed reforms is expected to occur from late 2019 to June 2020.

Thirteen public consultations were conducted in relation to medical device regulation, progressing recommendations of the MMDR and seeking views on proposed enhancements. An additional four consultations were conducted by the International Medical Device Regulator Forum, of which TGA is a member. Details of all past and current TGA consultations are available on our website.

The Uniform Recall Procedure for Therapeutic Goods was amended to introduce a more flexible and cost effective method for industry to communicate its consumer level recall actions to members of the general public.

The TGA commenced the development of an online e-form to facilitate more efficient notification and processing of industry recall notifications.

Self‑assessed rating: Met

External validators acknowledged our willingness to consult with industry using both formal and informal avenues. Feedback recognised the ongoing revision of regulations and regulatory guidelines required to meet the needs of patient safety and industry. Feedback also acknowledged efforts made to increase the effectiveness of our operations, such as accepting comparable overseas regulator reports as evidence for applications. Overall, stakeholders' comments were mixed, with industry members representing some of the smaller sectors noting that they have not yet realised much benefit from the numerous reform processes we have undertaken. Stakeholders encouraged us to continue to engage early and often, including prior to formal consultations.

Identified opportunities for improvement

The TGA regularly hosts and attends both formal and informal meetings with industry and other stakeholders. These meetings provide insight into the current and emerging issues being experienced by regulated entities as well as providing transparency for industry as to the processes and constraints of the TGA. We will continue to seek feedback to improve the effectiveness of our workshops and activities. We will also use these workshops and informal meetings to seek feedback and stakeholder input ahead of publishing formal consultations.

There is ongoing work involved in reviewing and enhancing our education material for industry and consumers. We are also working to improve the support we provide to SMEs, researchers, start-ups and interested organisations to help them better understand regulatory requirements.

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