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TGA key performance indicators: July 2015 to June 2016

14 November 2016

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KPI 3 Actions undertaken by regulators are proportionate to the regulatory risk being managed

KPI 3.1 Regulators apply a risk-based, proportionate approach to compliance obligations, engagement and regulatory enforcement actions.

3.1a Outcomes of completed investigations of alleged offences.

There were no enforceable undertakings entered into during the period.

One matter was referred to the Commonwealth Director of Public Prosecutions (CDPP) for assessment. One court outcome was finalised and published on our website along with the outcomes of other compliance actions.

Of 1,760 completed investigations, 946 warnings were issued and one matter was referred to the CDPP.

Of 2,526 products investigated, prescription medicines comprised 71%, complementary medicines 18%, OTC medicines 1.8%, biologicals 1.9% and medical devices 3.9%.

3.1b Publication of evidence of compliance activities to support the continued availability of safe, effective and high quality therapeutic goods for the Australian public.

We use a staged risk management approach to compliance that attempts to identify entities at risk of unintentional or deliberate non-compliance and collect intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

Our Laboratories Branch undertakes targeted testing of medicines and devices according to the risk they pose to the public. The outcomes of samples and products tested by type of therapeutic good and the percentage which failed is reported in the TGA Performance Statistics Report, which is published on our website. Excluding samples tested for accreditation, harmonisation and quality control, 1,696 samples of 761 products were tested. There was a failure rate of 26%, with 30% of medical devices failing, 0.5% of prescription medicines, 19% of OTC medicines and 20% of complementary medicines failing. 76% of unregistered products failed, these often being adulterated complementary medicines or counterfeit products.

We publish details of listed medicines cancelled from the ARTG following compliance reviews, including the provisions under which the cancellation was undertaken. We also publish details of cancellations and suspensions of medical devices (including IVDs).

Additionally, we publish statistics on the proportion of outcomes of inspections in terms of manufacturer performance (satisfactory, marginal and unacceptable) and the timeliness of inspections conducted within prescribed timeframes. Detailed information can be found in our Performance Statistics Report which is published on our website.

KPI 3.2 Regulators' preferred approach to regulatory risk is regularly reassessed. Strategies, activities and enforcement actions are amended to reflect changing priorities that result from new and evolving regulatory threats, without diminishing regulatory certainty or impact.

3.2a Information on the TGA's risk framework published on the TGA website, and regularly kept up-to-date.

The Therapeutic Goods Act 1989 underpins our work and outlines a risk-based regulatory framework for therapeutic goods.

Some examples of documents describing this include:

  • TGA Regulatory Framework - outlines how we regulate according to risk
  • TGA Regulatory Compliance Framework.

During the reporting period, advice was provided to the Government in response to the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation, and a budget measure was published in the May 2016 Budget. Work is currently underway to review and strengthen our regulatory framework and assessment of risk in response to the Review.

3.2b Information on activities undertaken to ensure that a risk-based approach is taken to prioritise complaints and other signals of possible non-compliance with regulatory requirements.

The Regulatory Compliance Committee monitors our compliance actions and practices. Complaints and other signals of possible non-compliance are prioritised for investigation and potential regulatory action based on the level of risk posed. Factors influencing priority include consumer safety and the risk or nature of the regulatory breach. Priority is based on factors that:

  • could significantly mislead the Australian public, particularly where there is a health impact
  • are likely to become widespread if we do not intervene
  • are of national or international significance
  • involve a new or emerging issue of concern
  • are the subject of public scrutiny and concern
  • could lead to a loss of stakeholder confidence in us or therapeutic goods.

For investigations that identify a potential safety or quality risk, testing of samples may be required. The results of testing determine if further action is required, such as a risk assessment, cancellation and/or recall. Appropriate enforcement actions (and appropriate follow-up) are implemented based on the risk assessment and investigation of post-market issues.

For safety reviews, a risk-based process has been developed for the screening and prioritisation of signal investigations. This process provides a rationale for allocation of resources and ensures we can respond to emergent safety issues. All identified issues are recorded and acted upon within a timeframe appropriate to their impact on public health. If a safety concern relating to a medicine or vaccine is identified, a range of regulatory action may be taken.

KPI 3.3 Regulators recognise the compliance record of regulated entities, including using earned autonomy where this is appropriate. All available and relevant data on compliance, including evidence of relevant external verification is considered.

3.3a Information on activities undertaken to ensure that a risk-based approach is taken to monitoring and compliance activities.

Proportionate compliance activities

We monitor the market for signals of potential non-compliance across the range of regulatory areas covered by the Therapeutic Goods Act 1989 and employ a uniform risk-based approach to determining the significance of any signals detected and the appropriate regulatory response.

We can communicate regulatory requirements and compliance expectations quickly and directly to a market-entry applicant and can deny market access to applicants who cannot demonstrate compliance with these requirements. Providing regulatory education to applicants at or before this point can help to minimise non-compliance once a product is marketed.

Scheduling of inspections based on compliance records

We employ risk-based inspection frequency matrices to guide the frequency of inspections. Manufacturer performance at inspection is categorised as satisfactory, marginal and unacceptable with further granularity provided by applying a high, medium or low risk rating. These ratings are applied when setting the date for reinspection. The matrix also takes into account product and process risks.

Before scheduling inspections, we consider emerging trends, recalls, adverse events, results of laboratory testing, feedback and inspections undertaken by other regulators and manufacturer profiles that have been updated to reflect any significant changes with the company.

Targeted complementary medicine reviews are based in part on the compliance record of the particular sponsor.

During the reporting period, the focus was on raising compliance levels of Australian manufacturers.

Product Safety monitoring

All post-market safety-related activities are undertaken using a risk-based approach under our therapeutic product vigilance framework. There were 37 products with a Risk Management Plan (RMP) identified as being a high priority for periodic safety update review, equalling one-third of products approved with an RMP evaluation. The majority of RMP evaluations were conducted for new chemical or biological entities, and applications to extend the indications of registered products.

Recalls

We use a risk-based approach to determine the classification and level to which a recall is undertaken (consumer level, retail level, hospital level or wholesale level) by considering the significance of the hazard, the channels by which the goods have been distributed, and the level to which distribution has taken place.

All recalls are risk assessed and classified into Class I, II and III which aids in the prioritising of actions. Class I and Class II actions are safety related with highest priority given to Class I issues which can result in serious injury or death to patients or users. Class II issues could cause illness, injury or result in mistreatment, but are not Class I. Class III actions occur when issues may not pose a significant hazard to health, but action may be initiated for other reasons e.g. quality related issues.

Out of the 667 recalls for medicines and medical devices undertaken during the reporting period, 130 were Class I, 463 were Class II and 74 were Class III.

Advertising

Where we receive a complaint regarding advertising it is triaged and prioritised based on the risks that the advertising could pose, primarily to public health and safety, but also our compliance activities and regulatory responsibilities.

During the reporting period, we received 312 complaints about the advertising of therapeutic goods. Where evidence of non-compliance with the legislative requirements is identified, the matter is addressed in the context of our Regulatory Compliance Framework.

Self-assessed rating of performance against KPI 3 for 2015-16
Met Substantially met Not met

Strong performance against all of the measures under the KPI

Strong performance against most of measures under the KPI Poor Performance against all of the measures under the KPI

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