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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 2 - Communication with regulated entities is clear, targeted and effective

Measures/metrics Evidence (performance in 2018-19)

KPI 2.1

Regulators provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience.

The TGA continually reviews, develops and updates regulatory guidance to reflect current best practice, as well as to comply with Australian Government requirements and international standards for web content accessibility.

In September 2018 the TGA Facebook page was launched. This created an additional channel to educate and inform stakeholders and consumers about the role of the TGA in providing safe medicines and medical devices to Australians. During this period, we created 351 posts and gained 5,924 followers.

Twelve webinars on different topics relating to regulation of therapeutic goods were hosted by the TGA. The average webinar attendance was 148 attendees.

The TGA Advertising hub, with related eLearning and video, decision tree, guidance and new fact sheets, went live on 1 July 2018 to support the new complaints handling framework and the changes to the Advertising Code. This included specific materials for consumers on identifying non-compliant advertising and complaints processes.

The News section of the TGA website averaged 42 items per month which consisted of announcements and information updates. These were also communicated via other channels, such as social media and email subscription lists, keeping stakeholders informed of published guidance, current issues, media releases, upcoming consultations, and other relevant information.

In this reporting period 62 new guidance documents were published, and 50 existing guidance documents were updated.

During this period important updated guidelines came into effect outlining regulators responsibilities regarding a number of regulatory changes: updated exemption status for tampons, menstrual cups and disinfectants; the introduction of new legislation requiring patient implant cards and information leaflets to be supplied (including for permanently implantable devices); providing updated information on issues that are of high interest to consumers and stakeholders (e.g. the breast implant and transvaginal (urogynaecological) surgical mesh hubs on the TGA website).

Self‑assessed rating: Met

KPI 2.2

Regulators consider the impact on regulated entities and engage with industry groups and representatives of the affected stakeholders before changing policies, practices or service standards

We engage in extensive formal consultation prior to changing policies, practice and service standards, and where regulation is being amended, to ensure that industry is informed and consulted prior to implementing change.

In addition to the consultations mentioned at KPI 1, we held the following stakeholder meetings throughout the period:

  • Met with the TGACC on three occasions on the proposed amendments to the 2018 Advertising Code.
  • Held a pre-consultation meeting with peak industry association representatives and technical experts from a number of manufacturers (prescription, OTC and complementary medicines) prior to drafting the updated Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
  • Undertook targeted consultation via TIWGG for GMP Clearance process changes throughout the reporting period. This included additional consultation regarding PIC/S Guide PE009-14 and the Good Clinical Practice Inspections Pilot Program.
  • Held discussions within the Regulatory and Technical Consultative Forum regarding updating the Medical Device Incident Reporting Scheme guidance document for sponsors.
  • Held discussion with the Regulatory Affairs Working Group regarding multiple areas, including opportunities for further process reforms to the standard medicine pathways, updates for older medicines and the industry's request to have an earlier view during the evaluation process on what regulatory decisions are likely to be.
  • Held regular discussions with the complementary medicines industry working groups including Complementary and OTC Medicines Regulatory & Technical Consultative Forum (COMTECH), Consumer Healthcare Products Australia (CHP Australia), Accord Australasia, Advisory Committee on Complementary Medicines (ACCM) and Chinese Medicine Board of Australia (CMBA) regarding general interest items that affect industry and MMDR reforms.
  • We also further built our understanding of commercial sensitivities for the ingredient supply industry. We contacted more than 200 proprietary ingredient suppliers and used the information received to inform our public consultation on making more information about ingredients in medicines available to consumers.

Self‑assessed rating: Met

KPI 2.3

Regulators' decisions and advice are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions.

As detailed in the TGA's Annual Performance Statistics Report, during the reporting period 99% of prescription medicine applications and 100% of device applications were completed within legislated timeframes.

In addition to publication of recall actions in the System for Australian Recall Actions database, a detailed TGA web statement is published for certain recall actions like Hazard Alerts for implantable medical devices, consumer level recalls and any other recalls that may have wider implications for public health and safety. These web statements include additional advice to consumers and healthcare professionals regarding the recall action undertaken. During the period there were 25 new or updated web statements and these were published within one to three business days following approval of the recall action, unless there were extenuating circumstances. This timeframe allows sponsors the opportunity to commence the required action prior to it being further publicised.

We have processed 2443 applications for inclusion of medical devices in the ARTG, and also conducted:

  • 156 level 1 compulsory audits (30-day target time frame - mean 24, median 15).
  • 236 level 2 Compulsory audits (60-day target time frame - mean 99, median 85).
  • 201 non-compulsory audits (mean 99 days, median 56 days).

We also have completed 273 of 279 conformity assessment applications in this period.

We approved 5,451 applications for prescription medicines, including 38 new chemical and biological entities, 53 extensions of indications and 73 major variations. 11 of the new medicines and extension applications were evaluated as priority applications. The time for approval for each of the pathways was well within legislated or operational timelines. For major applications:

  • 38 new chemical entities/new biological entities/biosimilars approved in a median 202 working days (for standard pathway; legislated 255 working days)
  • 53 extensions of indications approved in a median 197 working days (for standard pathway; legislated 255 working days)
  • 11 medicines and indications approved via the priority evaluations pathway in a median 123 working days (operational target of 150 working days).

Five applications for registered complementary medicines were approved, and 18 variations completed.

221 new over-the-counter medicines were approved, with 938 changes to existing medicines.

Self‑assessed rating: Met

KPI 2.4

Regulators' advice is consistent and supports predictable outcomes.

We are working to ensure that all published guidance material is of a high quality, is user focussed, accessible and adheres to Digital Transformation Agency standards.

We held six SME Assist 'Meeting Your Obligations' workshops (an increase of one compared to2017-18) and two targeted information sessions on subjects relevant to specific industry groups. The workshops had a total of 417 participants (an 85% increase from the last reporting period) and feedback was overwhelmingly positive.

14 internal reviews of regulatory decisions were finalised in this period, and 5 (36%) had their decisions revoked or substituted without consideration of additional information. All internal reviews were completed within legislated timeframes.

During this period, we were party to five matters before the Administrative Appeals Tribunal. Two matters were dismissed, one was resolved, one upheld and one is ongoing. None of the outcomes were related to issues relating to quality of TGA decisions.

Self‑assessed rating: Met

External validators commended our efforts to consult with the industry on relevant and significant issues through formal and informal channels, as well as providing additional channels of communication such as the TGA Facebook page. Stakeholder comments noted that some of our communication could have been more timely, for example consultations for legislation with known sunsetting dates could have been published earlier, and emphasised that guidance material and workshops were the most valuable forms of targeted communication.

Identified opportunities for improvement

We will continue to review and adapt our services to ensure we meet industry's education needs by providing up to date, high quality and relevant content on the TGA website and relevant social media channels. We are also committed to direct communication with stakeholders, and to providing clear and consistent advice in a timely manner. We will continue to engage with industry to educate them on their regulatory responsibilities, and raise our awareness of the issues they are facing.

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