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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
KPI 3 Actions undertaken by regulators are proportionate to the regulatory risk being managed
|The self-assessment rating of met is based on our risk based approach to the regulation of therapeutic products. We have continued to develop risk based frameworks aimed at enhancing voluntary compliance by regulated entities. Our approach to risk is proportionate to the risk regulated. We monitor signals of non‑compliance and base intervention on compliance history.|
|Most external validators agreed with our self-assessment, noting that our regulatory framework is risk based and addresses risk similarly to other jurisdictions.|
|KPI 3.1||Regulators apply a risk-based, proportionate approach to compliance obligations, engagement and regulatory enforcement actions.||
64% increase in investigations undertaken.
Publication of laboratory results.
Publication of safety alerts, cancellations from the ARTG and destruction of counterfeit products.
|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.||
Effective prioritisation of compliance activity through the regulatory framework and Regulatory Compliance and Enforcement Plan.
Monitoring and appropriate prioritisation through the Regulatory Compliance Committee.
|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.||
Monitoring and compliance activities are informed by risk assessment, risk based prioritisation and compliance performance history including inspections of manufacturing facilities and product testing.
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.
During the reporting period 5,407 products were investigated, comprising prescription medicines (82%), complementary medicines (11%), Over the Counter medicines (1%), biologicals (0.5%) and medical devices (3%). Of the 2,978 completed investigations, 2,054 warnings were issued. 1,774 of these warnings were for prohibited importation of therapeutic goods and all of these goods were destroyed. 94% of compliance investigations involved the importation of therapeutic goods and 5% involved supply.
There was a significant increase in the number of products investigated (64%). Although we use intelligence from a range of sources, the increase was largely attributable to continued referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.
In 2016-17 forty one safety alerts were published on our website as a result of compliance action.
Our strong compliance and enforcement program ensures that products intended for supply outside of the therapeutic goods regulatory framework are removed from the market. This assists industry in maintaining product integrity and meeting community expectations in relation to the safety and quality of therapeutic goods.
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 risk management approach to compliance to identify entities at risk of unintentional or deliberate non-compliance and to collect intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. Publication of evidence relating to our compliance activities on our website through a range of reports, notices and results provide transparency for industry and other stakeholders. Our Half Yearly Performance Snapshot July to December 2016 and Annual Performance Statistics Report July 2016 to June 2017 include detailed statistics on our regulatory compliance activities.
We publish details of medicines and medical devices (including IVDs) that have been cancelled or suspended from the ARTG, including the provisions under which the cancellation or suspension was undertaken, and the grounds for each cancellation or suspension.
We received 44 recommendations from the Complaints Resolution Panel to order specific advertisers to comply with advertising requirements. Recommendations are generally resolved by taking an educative approach with advertisers. While no Regulation 9 orders (to withdraw an advertisement and publish a retraction or correction) were issued in 2016-17, we are working towards publishing the outcomes of recommendations resolved through an educative approach in the next reporting period.
Publication of Laboratory Results
The TGA laboratories test therapeutic goods to monitor compliance with regulatory requirements and to investigate adverse events, problems and complaints. The testing program is an important part of our post-market monitoring scheme and whole-of-life-cycle approach to regulation.
We use a risk-based process to determine which products are selected for testing and what tests are performed and we allow capacity to respond quickly to emerging issues in the marketplace.
In response to the Contestability Review of TGA Laboratories and the MMDR Review, in 2016-17 we undertook to publish laboratory testing results to:
- increase transparency and understanding of how our testing program contributes to regulation of therapeutic goods
- increase consumer confidence in therapeutic goods supplied in Australia
- encourage industry knowledge of, and compliance with, legislative requirements
- promote our post-market monitoring activities
- align with other regulators who publish testing results.
The Database of TGA Laboratory Testing Results was launched on 5 June 2017 providing information to the public about the 2000-plus samples we test each year. Consumers and health professionals can now clearly see which products have been tested, whether they passed or failed, and any regulatory action taken.
To complement the database and provide context for the published test results, the TGA website was updated with new content about testing of therapeutic goods. A new series of Tweets was also launched on Twitter with the hashtag #TGAlabs and includes interesting information and hyperlinks to relevant pages on the 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. We use a Regulatory Compliance and Enforcement Plan and Risk Compliance Plan to guide the prioritisation of investigations and risk management activities. These plans ensure consistent decision making in relation to regulatory activities and are published on our website. We also publish a Scheduling Policy Framework, which provides information on risk assessment in the scheduling process for medicines.
We publish information in relation to risk profiles and our compliance activity to encourage voluntary compliance with the regulatory framework. This ensures that sponsors and others are aware of the risk based considerations that inform decision making throughout the life cycle of a product.
A risk based approach is being implemented as part of the Government's response to the Expert Panel Review of Medicines and Medical Devices Regulation. Reforms to the regulatory framework consider where reducing the level of pre-market assessment can occur while maintaining consumer protection. Where necessary, decreased pre-market activity will be balanced by increased post-market activity. Examples of adopting a risk based approach include allowing low risk variations to medicines to be made by notification where changes do not impact on safety, quality or efficacy, and allowing access to products of acceptable risk which are not listed on the ARTG via notifications.
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.
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, in accordance with our Regulatory Compliance Framework and regulatory responsibilities. Over the period we received 432 complaints about the advertising of therapeutic goods.
Further information is available at KPI 3.3.
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.
We undertake a range of regulatory activities across the organisation and apply a risk based approach as we regulate all stages of the product life cycle. We review risks associated with monitoring and compliance and streamline activities to minimise impact on regulated entities.
We employ risk-based matrices to guide the frequency of inspections of manufacturing facilities. Manufacturer performance at inspection is categorised as good, satisfactory, marginal and unacceptable with further granularity provided by applying a high, medium or low risk rating for the type of products being manufactured when setting the date for reinspection. Manufacturers with a strong history of compliance performance and lower risk are inspected less frequently. Those with poor compliance performance are rated higher risk and are inspected more frequently.
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 significant changes.
In consultation with industry, we have acknowledged the benefit of recognising manufacturers who consistently achieve a good outcome by implementing a modified reinspection regime. In conjunction with this new risk matrix, consistent achievement of a good outcome is also recognised by reduced scope reinspections, with inspectors spending less time onsite depending on the risk rating achieved.
We also use a risk based approach to determine the classification and level (consumer, retail, hospital or wholesale) to which a recall is undertaken 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 or III which aids in prioritising recall actions. Class I and Class II actions are safety related. The highest priority is given to Class I issues which can, or have, resulted in serious injury or death to patients or users. Class II issues are those which could cause illness, injury or result in mistreatment. Class III issues may not pose a significant hazard to health, but action may be initiated for other reasons e.g. quality related issues.
Of the 632 recalls for medicines, medical devices and biologicals undertaken during the reporting period, 119 were Class I, 462 were Class II and 51 were Class III.
All post-market safety-related activities are undertaken using a risk based approach. In accordance with our pharmacovigilance guidelines, mechanisms are used to monitor the safety of therapeutic goods, including:
- evaluation of Risk Management Plans, which describe how sponsors will monitor and mitigate known and potential safety concerns
- for medicines, regular review of adverse events reported to the Adverse Drug Reaction System
- communications with international regulatory agencies and Australian state and territory health authorities
- reviews of literature.
When a potential safety signal is identified for a therapeutic good it is prioritised for further investigation and follow-up action depending on the level of risk. Other areas of the TGA are notified and may undertake proactive compliance reviews of therapeutic goods or inspections of manufacturing facilities.
In 2016-17 we completed a voluntary pharmacovigilance Inspection Pilot Program. This involved inspection of participating sponsors' pharmacovigilance systems including records of adverse events and reports made to us. Following the success of the pilot, implementation of a full program is underway.
We use a risk management approach to select and prioritise products for testing by our laboratories. A risk assessment tool considers particular product groups against 16 risk sources to identify those with the highest relative risk. The proposed testing plan is independently reviewed annually to ensure it is appropriate, risk based and addresses priority areas.