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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
KPI 2 Communication with regulated entities is clear, targeted and effective
|Our self-assessment rating of substantially met is based on medical device timeframes for application audits not being met, although these timeframes are not mandated in legislation. The legislated timeframes for medical device Conformity Assessment were met in all cases.|
|The level of our consultation with industry was described as "first rate". We were also referred to as a model regulator.|
|KPI 2.1||Regulators provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience.||
Improvements to our website content, and improved compliance with accessibility requirements.
Improved guidance material published, with a particular focus on new and changed regulatory requirements.
|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.||
31 public consultations held with more than 1,600 submissions received and considered.
Considerable consultation including co-design activity where processes are being varied.
|KPI 2.3||Regulators' decisions and advice are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions.||
Continued processing of applications within target timeframes.
Launch of the MedSearch app, and continued efforts to ensure availability of therapeutic goods information.
|KPI 2.4||Regulators' advice is consistent and supports predictable outcomes.||
22 reviews of original decisions were conducted, with two (9%) being substituted.
KPI 2.1 Regulators provide guidance and information that is up to date, clear, accessible and concise through media appropriate to the target audience
2.1a Percentage of pages on the TGA website that comply with the Australian Government accessibility requirements.
We continually develop, review and update regulatory and technical guidance material to comply with Australian Government requirements and international standards for web content accessibility. Web Content Accessibility Guidelines (WCAG) requirements include the need for the content to be findable, scannable, readable and accessible. A systematic approach to maintaining content is also applied. We have continued to refine our website search platform and our standard database model through which data can be easily discovered, navigated and disseminated.
90% of TGA information on our website is WCAG2.0 compliant. The remaining content includes a large number of third party documents, for example consultation submissions, Product Information (PI) and Consumer Medicine Information (CMI) documents.
We actively monitor and review material on the website to ensure it meets WCAG2.0 compliance requirements, and is user-focused.
2.1b Improvements made to guidance documents, forms, and information on the TGA website
We have undertaken significant work in improving our guidance material with a focus on providing information about new and changed regulatory requirements, such as those resulting from MMDR reforms.
Two new labelling orders were determined in August 2016 after extensive consultation. We published guidance to help sponsors and manufacturers of medicines meet the new labelling requirements, and information for consumers and health professionals. The new requirements specify more substances that must be declared on a label if they are present in a medicine. We explained the timeframe of the new labelling requirements and listed the allergens that will be declared on labels that meet the new requirements.
Following the decision to down-schedule medicinal cannabis, we published an overview of the regulation of medicinal cannabis which explains the roles of different regulators. We also published specific information about access, manufacture and conforming with the new therapeutic goods order TGO 93 (Quality Standard for Medicinal Cannabis Products).
As part of MMDR reforms, guidance was developed on the new process to notify us of minor changes to registered medicines that did not affect safety, efficacy or quality. Existing guidance on making minor variations to prescription medicines was also updated. We published new guidance on Priority Review designation and eligibility criteria as part of the implementation of the new Priority Review pathway.
For sponsors of listed medicines, we explained how non-compliance can be avoided. The web page on compliance and education for listed medicines provides advance notice of timeframes, expectations and impacts of compliance reviews. This enables sponsors to prepare for reviews and reduces the likelihood of lost business due to non-compliance.
We provided guidance on:
- products containing folate or folic acid for sponsors
- compounded medicines and dose administration aids for medicine manufacturers
- clinical evidence for medical device manufacturers
- how to vary an ARTG entry for a biological and a medical device.
Over the period we amended or published over 51 new guidance documents.
2.1c Number of educational materials and other documents developed or updated for stakeholders (industry, consumers, health professionals). Number of downloads of these from the website and social media, and data on user satisfaction where available.
We published a range of educational material for consumers, health professionals and industry to assist with informing stakeholders about changes to therapeutic goods regulation and regulatory reform activity. Ensuring stakeholders are aware of MMDR reforms and how they impact on industry is critical to successful implementation.
Key materials included:
- a codeine 'Information Hub' centralising information on the codeine scheduling decision
- a webpage with information specific to complementary medicines regulatory reforms
- a draft list of permitted indications and other materials to support implementation of the permitted indications reform, allowing sponsors and industry to comment and suggest additions prior to the list being finalised
- an access to medicinal cannabis flow chart explaining access pathways for unapproved medicinal cannabis products
- a landing page for the new Priority Review pathway for the registration of prescription medicines and guidance documents to assist sponsors with making an application for Priority Review designation.
The information in the following tables focuses on materials either developed or updated during 2016-17. Additional materials are made available to stakeholders via our website and social media channels.
|Name of material||New or updated||Format||Publication medium||Number of views/ downloads|
|Medicines and medical devices regulation review||New||Landing page & related content||TGA website||12,810 views|
|Medicinal cannabis products: overview of regulation||New||Web page||TGA website||6,000 views|
|SME Assist||New||Landing page & related content||TGA website||3,015 views|
|Medicinal cannabis - what's happening?||New||Presentation||Slideshare||2,594 views|
|Current manufacturing inspection trends||New||Presentation||Slideshare||1,470 views|
|Compliance and education for listed medicines||New||Web page||TGA website||1,435 views|
|Making an ACE declaration||New||Video||YouTube||473 views|
|Name of material||New or updated||Format||Publication medium||Number of views/ downloads|
|Access to medicinal cannabis products||New||Web page||TGA website||25,965 views|
|Australia's medicine labels are becoming clearer||New||Web page||TGA website||8,687 views|
|MedSearch||New||Landing page & related content||TGA website||3,155 views|
|Consumer fact sheet: Codeine-containing medicines: Harms and changes to patient access||New||Web page||TGA website||2,429 views|
|Special Access Scheme: frequently asked questions||New||Web page||TGA website||1,748 views|
|Oral probiotics indicated for vaginal conditions||Updated||Web page||TGA website||1,435 views|
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
2.2a Details of formal consultations completed during the reporting period, including evidence that the TGA has closely considered submissions from stakeholders.
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. We conduct consultations as part of our broader stakeholder engagement work.
For some change processes, such as amendments to our legislation or regulations, a consultation process is required in advance of a decision. The consultation may be part of a RIS or it may be used to inform a RIS that is developed after the feedback from the process has demonstrated a need for change. Where an issue is significant, in order to obtain valuable feedback, we may conduct a consultation absent of any formal requirement to do so. We also use the consultation process to review our existing business practices to ensure they are operating efficiently, minimise the administrative burden for industry and ensure timely approval of therapeutic goods for use in Australia.
We publish information about all formal consultations on our website including information about the scope of the consultation and timeframe, as well as background to the consultation and how to provide a submission. We review all submissions and provide feedback through our website. The submissions we receive are also published on our website.
At the conclusion of a consultation, we publish a TGA Response and Outcome Summary. The Outcome Summary provides information about our consideration of the feedback of our stakeholders, and how we aim to address their concerns or comments.
During the reporting period we engaged in 31 formal public consultations, 13 of which were undertaken to inform the implementation of MMDR recommendations. Industry feedback has informed our position in relation to upcoming changes to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.
A key area of the stakeholder survey focuses on collaboration, consultation and feedback. Consistent with the previous reporting period, these measures show more opportunities for improvement compared with other focus areas of the survey. While outcomes for these areas were not as strong overall, the results were generally more positive than negative, with evidence of year on year improvement. The strongest outcomes were in relation to the ability to proivde feedback (68% in 2016-17 compared with 62% in 2015-16), as well as a strong rise in relation to the range of feedback channels (53% compared with 46%) and opportunities to provide input into key decisions (68% compared with 62%).
2.2b Evidence of discussions with affected stakeholders before TGA processes are changed.
In addition to formal consultation processes, we continually engage with sponsors and industry groups that may be affected by changes to regulatory or business processes. We held a number of webinars to provide open communication channels for industry, encourage submissions, and invite questions about consultations in an informal setting. Further details about our conference and event participation are available on our website.
Three targeted consultation forums were held to 'co-design' complementary medicines reforms. The forums included large, medium and small sponsors, industry peak bodies, manufacturers and consumers. Discussions assisted in shaping the content of our public consultation paper and ensured transparency in the development of reforms.
Affected stakeholders, including medicine sponsors, healthcare practitioners and other government bodies were consulted in the review of safe use of flexible intravenous fluid bags. This input informed the decision that new labelling requirements were not an appropriate regulatory measure. Instead, educational material was prepared to inform practitioners of risks and to highlight existing label advisory statements.
The NSW Poisons Information Centre (as representative of all six Australian centres) and potentially affected sponsors were consulted as part of the review and re-making of the ministerial standard Child-resistant packaging requirements for medicines.
We presented ARCS webinars on:
- Expert review of medicines and medical devices regulation (December 2016) outlining proposals for implementation of several recommendations from the Review of MMDR relevant to prescription medicines
- including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, and the use of overseas assessment reports
- Update on PI reformatting - have your say (May 2017) including information on our project to reformat PI documents.
We actively engage with medical device peak industry bodies formally and informally. We hold quarterly meetings of RegTech. A key focus of RegTech in 2016-17 was the transition to the new IVD framework for commercial and in-house IVDs. Guidance material was developed in response to stakeholder consultation and we collaborated with RegTech members to prepare material for a biennial Medical Devices Sponsor Information Day to help industry understand and engage with medical device regulation.
We involved industry representatives in user testing activities for the new online application form for Conformity Assessment; outlined common errors with medical device applications (and clinical evidence) with key industry bodies so they could share this information with their members; and discussed with peak industry groups a project to enhance post market monitoring and analytics for medical devices.
Priority Review pathway
As part of the Government's Response to the Review of Medicines and Medical Devices Regulation, we developed and implemented a Priority Review pathway on 1 July 2017. The Priority review pathway benefits our different stakeholders by:
- providing consumers and healthcare professionals with faster access to new medicines
- providing sponsors with a predictable and transparent pathway to formalise the expedited registration process.
In October 2016, we consulted publicly on the proposed eligibility criteria and designation process for both Priority Review and Provisional Approval. We received 33 submissions, which showed broad stakeholder support for the proposed approach, with suggested modifications to the eligibility criteria; timeframe for lapsing the designation; and publication of designation decisions.
Stakeholder feedback informed the policy position and changes to the Therapeutic Goods Regulations 1990. The eligibility criteria were revised to ensure alignment with similar approaches taken by overseas regulators while meeting the Government's objectives for the expedited pathways.
We received direct feedback from an industry workshop in November 2016 and also eight submissions in response to targeted industry consultation on the Priority Review designation and registration processes conducted in late 2016.
We worked collaboratively with industry to develop our flexible Priority Review business process, with a target timeframe of 150 working days. Industry feedback informed the supporting guidance material which reflects the details of the pathway. The guidance is an evolving document that can be updated to address or clarify new issues as they arise.
KPI 2.3 Regulators' decisions and advice are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions
2.3a Information for consumers, health professionals and industry on the basis for the TGA's decision making, including any work to improve the quality of our decision making.
In response to the MMDR review, the Therapeutic Goods Act 1989 has been amended to provide review and appeal rights for persons who apply to have a new ingredient permitted for use in listed complementary medicines. The legislative amendments increase transparency of our administrative processes, improve procedural fairness and remove barriers to business.
The published guidance documentation on the Priority Review pathway and the Orphan Drug program includes details of how TGA delegates will make decisions regarding eligibility for these designations and how they will be published on our website. This provides transparency of these new processes for sponsors to consider before making an application.
Information on post-market regulatory decisions detailing the basis for the decision are published on our website, including details of medical devices (including IVDs) that have been cancelled or suspended from the ARTG, the provisions under which the cancellation or suspension was undertaken, and the grounds for each.
2.3b Percentage of pre‑market applications and post-market activities processed in target timeframes.
Detailed statistics on processing of pre-market applications and post-market activities and associated timeframes are provided in the TGA Annual Performance Statistics Report 2016-17 which is available on our website.
The percentage of pre-market applications processed within their respective timeframes were:
- 100% of prescription medicine applications (new chemical entity, fixed dose combinations, extension of indications and generic medicines)
- 100% of new over-the-counter medicine applications
- 100% of medical device conformity assessment applications
- 100% of medical device (including IVD) inclusion applications not selected for audit
- medical devices (not-IVD) - 59% of non-compulsory audits, 80% of Level 1 compulsory audits and 24% of Level 2 compulsory audits
- IVD medical devices - 80% of non-compulsory audits and 77% of compulsory audits (mTFR).
In relation to post-market activities, 95% of medical device incident reports were processed within target timeframes.
2.3c Publication of information for health professionals, consumers and industry when medicines are registered and/or new information arises on therapeutic goods.
We regularly issue news updates, tweets and public notices for consumers, health professionals, industry and the community. When published on our website, ARTG entries include, where applicable, the approved PI and CMI documents. We also launched MedSearch™, an app designed for use by the general community and health professionals which provides easy mobile access to PI and CMI documents for medicines.
|Type of information||Number|
|Australian public assessment reports (AusPARs)||51|
|Expert advisory committee meeting statements||21|
|Scheduling advisory committee interim and final decisions||12|
|New Chemical Entities (NCE) approvals||34|
|Extension of Indications (EOI) approvals||51|
|Web statements: recalls/medicines safety alerts/suspensions||
Medicines - 78
Medical devices - 47
|Medicines Safety Updates||5|
|Medical Devices Safety Updates||6|
|Early warnings - potential safety issues||2|
|Medicine shortage web statements||6|
The searchable database known as the System for Australian Recall Actions (SARA) provides consumers, healthcare professionals, sponsors, wholesalers, hospitals and retailers with access to information about recall actions undertaken in Australia. In 2016-17, SARA published 632 recall actions which included 32 medicine, 598 medical device and 2 biological recall actions.
A graduate group in the Department of Health developed the MedSearch app – taking the product information search capability available on the TGA website and recreating it for iOS and Android mobiles. The app allows health professionals and consumers to quickly search for and retrieve product information, including scientific information about medicines and using medicines safely and effectively. The MedSearch app also includes extra features, such as the ability to add results to a favourites list for easy access.
The availability of the MedSearch app means that medical professionals and consumers can access up to date PI and CMI anytime and from anywhere. This app significantly enhances the availability of information to assist with using medicines safely, effectively and in line with their intended purpose.
KPI 2.4 Regulators' advice is consistent and supports predictable outcomes
2.4a Percentage of substantive regulatory decisions subject to internal review, for which the original decision is revoked and substituted, without consideration of additional information.
We estimate that we make more than 34,000 regulatory decisions per year. In 2016-17 only twenty-two formal regulatory decision reviews were conducted including two (9%) for which the original decision was revoked and substituted without consideration of additional information. Both of these were in relation to Special Access Scheme (SAS) Category B applications.
All internal reviews were completed within the prescribed legislated timeframes.
2.4b Outcomes of matters referred by sponsors to the Administrative Appeals Tribunal (AAT), including where TGA decisions are upheld, and where the outcome is indicative of an issue about the quality of the decision.
In 2016-17, we were party to ten matters before the Administrative Appeals Tribunal. Of the ten matters, three applicants seeking review of the original decision withdrew their appeal. One matter was resolved by way of consent orders. One matter progressed to hearing and the TGA's original decision was upheld by the tribunal. In relation to a further matter that went to hearing, the AAT had not handed down its decision by the end of the reporting period. The remaining four matters were before the AAT at the time of preparing this report. None of the outcomes that eventuated indicated any issue relating to the quality of TGA decisions.