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TGA key performance indicators: July 2015 to June 2016
KPI 2 Communication with regulated entities is clear, targeted and effective
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 have an ongoing program of developing, reviewing and updating 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 required. To meet these requirements we have created a new 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.
We have also delivered a completely new website search platform to improve access to content on the website.
2.1b Improvements made to guidance documents, forms, and information on the TGA website
Guidance material is intended to lend further clarity to the regulatory processes, to assist industry and other stakeholders to understand and comply with our requirements. We continually develop and update regulatory and technical guidance material. This includes simplified navigation of our website pages.
During the reporting period, we published a range of new and updated guidance documents and material, including:
- an evaluation plan estimator for applicants who lodge applications for prescription medicine registrations. This provides estimated dates for the milestones in the registration process to aid in planning applications and was viewed 3,725 times in the reporting period
- prescription medicine guidance, such as Common Technical Document (CTD) Module 1, general dossier requirements, extensions of indications, additional trade names, non-eCTD electronic submissions, preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
- updated guidance for sponsors on evidence of Good Manufacturing Practice (GMP) compliance for prescription medicines
- revised guidance for applicants lodging prescription medicine registration applications to include information on the pre-submission pilot registration pathway, such as questions and answers and a fact sheet to aid planning
- information about changes to medicine ingredient names to align with names used internationally, including to ten pharmaceutical industry organisations, seven medications software/information industry organisations, four consumer organisations and eight government organisations.
- guidance on regulatory requirements for in vitro diagnostic medical devices (IVDs)
- revised guidance on the reduction of assessment fees for conformity assessments of medical devices (including IVDs), providing industry with greater clarity on the assessment fees that may apply
- revised forms to make it easier to collect information from sponsors, including consultation submissions, electronic forms to notify medicine shortages and online forms for clinical trial notifications and custom made medical devices.
Over the counter medicines
- a major revision of the Australian regulatory guidelines for over the counter (OTC) medicines and the TGA approved terminology for medicines, including guides on registration and change processes, CTD Module 1 for OTC medicines, mandatory requirements for effective OTC medicine applications, technical guidance, flowcharts and tools for sponsors
- an application form for sponsors to use when applying for permission to export therapeutic goods for clinical trials.
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 created various educational materials for consumers, health professionals and industry during the reporting period, including:
- two instructional and training videos: a user guide to the new TGA Business Services for industry; and information for consumers about buying medicines online
- 26 presentations for various industry events and 10 presentations for the Devices Sponsor Information Day, providing an overview of the regulatory life cycle for medical devices
- a series of educational materials to raise awareness about upcoming changes to medicine ingredient names.
Additionally, there were 13 fact sheets and frequently asked question (FAQ) documents including:
Significant downloaded or viewed materials for 2015-16 for each stakeholder group are highlighted below.
|Name of material||New or updated||Format||Publication medium||Number of views/downloads|
|Updating medicine ingredient names||New||Posters & website||TGA website & direct email||
18,525 views (Website)
|Cosmetic injections: beware of 'home based' beauty services||New||News item||TGA website||1,132 views|
|Stem cell treatments and regulation - a quick guide for consumers||New||Questions and Answers||TGA website||704 views|
|Managing the Challenges and Opportunities of Breakthrough Therapies||New||Presentation||SlideShare||434 views|
|Buying medicines and medical devices online||New||Video & webpage||YouTube, TGA website||225 views (launched on 26 June 2016)|
|Name of material*||New or updated||Format||Publication medium||Number of views/downloads|
|TGA and industry presentations - Devices Sponsor Information Day 15 October 2015||New||12 presentations||SlideShare, TGA website||9,724 views|
|The new TGA Business Services site||Updated||Video||YouTube, TGA website||1,056 views|
|Evidence of GMP compliance for prescription medicines||Updated||Webpage||TGA website||2,677 views|
|Half Yearly Performance Report Snapshot (July to December 2015) and the interactive online summary||New||Report||TGA website||1,227 (between May and June 2016)|
The information reported in the above two tables focuses on materials either developed or updated during the reporting period. However, additional materials are made available to stakeholders via the TGA website and social media channels.
These materials can be accessed by stakeholders using various media channels including our website, the TGA Australia YouTube channel and SlideShare.
Education and awareness raising activities were also conducted to support adverse event reporting by consumers and health professionals and improved reporting interfaces were implemented.
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.
Some of the activities consulted on during the period included changes to regulatory practices or requirements, reviews of business processes, reviews of standards or guidelines, and fees and charges. For each consultation an internal report is prepared which outlines how submissions have been considered and what action has been taken in response. This forms the basis for our response which is published on our website.
Examples of completed consultations during the reporting period include:
- draft guidelines outlining our expectations for clinical evaluation reports and underlying evidence to be held by medical device manufacturers as part of their conformity assessment procedures
- proposed amendments to the Poisons Standard
- proposed adoption of specific European Union (EU) guidelines in Australia for medicines
- proposal for adoption of Pharmaceutical Inspections Convention Scheme/Pharmaceutical Inspections Cooperation Scheme (PICs) - GMP standards and revisions and improved consultation process on the adoption of PIC/s guidelines
- updates to medicine advisory statements.
During the reporting period 14 formal consultations were completed. We aim to publish consultation submissions and our response on our website within two weeks following consultation with the Minister.
2.2b Evidence of discussions with affected stakeholders before TGA processes are changed.
In addition to the formal consultation process, we engaged with sponsors and key industry groups that may have been affected by planned changes to regulatory or business processes.
Some examples of topics discussed with affected stakeholders include:
- development and implementation of changes to the prescription medicines process, specifically the pre-submission pilot for new chemical entities and new generic medicines
- introduction of requirements for medicine label advisory statements
- introduction of a revised fee structure for OTC medicine applications
- updates to the Australian Regulatory Guidelines for OTC Medicines, including changes to mandatory requirements and a reduction of target times for processing applications that comply with an OTC medicine monograph
- introduction of a legislative instrument with a single list that specifies the ingredients available for use in listed medicines.
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.
Information on pre market and post-market regulatory decisions detailing the basis for the decision are published on our website, including:
- ARTG entries: a publicly available online database of information about approved therapeutic goods that can be supplied in Australia, as well as those that have been suspended or cancelled
- AusPARs: information about the evaluation of a prescription medicine and the considerations that led us to a decision
- a list of Australian medicines manufacturers that have been issued with a GMP (manufacturing) licence
- the System for Australian Recall Actions: an online, searchable database containing information about recall actions for therapeutic goods
- outcomes of investigations into complaints about advertising
- outcomes of court actions relating to therapeutic goods.
During the reporting period, improvements to the quality of our decision making were implemented, including:
- updated decision letter templates to provide more consistent information to applicants regarding the legal provisions available to sponsors to review our decisions
- a program to seek ongoing feedback and provide training to internal review delegates.
A public subscription service is available and provides for automatic email notification of updates to the ARTG, safety-related alerts, revised guidelines, medicine shortages alerts, and other notices.
2.3b Percentage of pre-market applications and post-market activities processed in target timeframes.
Applications for market authorisation of therapeutic goods are processed with reference to target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good being considered. Some of these targets are specified in the legislation. Timeframes exclude 'hold times' where we are waiting for a response from an applicant following a request for information, and include any time for committee consideration.
During the reporting period, 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)
- 99% 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) - 66% of non-compulsory audits, 67% of Level 1 compulsory audits and 15% of Level 2 compulsory audits
- IVD medical devices - 53% of non-compulsory audits and 72% of compulsory audits (mTFR).
In relation to post-market activities, 100% 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. Some of the publications issued during the reporting period included:
- six editions each of the Medicines Safety Update and the Medical Devices Safety Update, providing health professionals with practical information about safety issues
- 109 web statements regarding safety alerts, shortages, reviews, early warnings or recalls affecting prescription medicines or medical devices.
In the TGA Stakeholder Survey 2015-16, overall reaction to education and publication activities was positive. Standout satisfaction ratings were achieved for the TGA update and TGA guidelines with 95.1% and 94.8% of users rating them useful to extremely useful in their roles respectively.
In November 2015 we launched the TGA Twitter channel to improve our information sharing on social media.
Some specific examples of information published on our website include:
- new prescription medicines and new or extended indications to currently registered products (including a subscription alert)
- AusPARs: reports include information about the evaluation of a prescription medicine and the consideration that led us to a decision
- CMI and PI documents for registered medicines (including any updates)
- a list of new or extended uses or new combinations of registered prescription medicines which is updated monthly
|Type of information||Number|
|Australian public assessment reports (AusPARs)||74|
|Expert advisory committee meeting statements||19|
|Scheduling advisory committee interim and final decisions||15|
|New Chemical Entities (NCE) approvals||35|
|Extension of Indications (EOI) approvals||18|
|Web statements: recalls/medicines safety alerts/suspensions||
Medicines - 68
Medical devices - 36
|Medicines Safety Updates||6|
|Medical Devices Safety Updates||6|
|Early warnings - potential safety issues||3|
|Medicine shortage web statements||4|
1 The publication of new or extended uses for prescription medicines commenced in January 2016.
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.
Internal reviews are undertaken when a person whose interests are affected by an initial decision requests reconsideration of the decision by the Minister under section 60 of the Therapeutic Goods Act 1989.
The decision maker reviewing an initial decision may confirm the initial decision, revoke the initial decision or revoke the initial decision and substitute a different decision.
We make more than 34,000 regulatory decisions every year. During the reporting period, we made decisions on 19 applications for internal review of regulatory decisions. Of these, five initial decisions (26%) were revoked, or revoked and substituted. However, in all five cases, additional information was made available to the internal review delegates that was not submitted at the time of the original application.
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.
During the reporting period nine matters were referred to the AAT and four of these matters were completed. Of these four, three applicants withdrew their application for a review. In the fourth case the applicant came to an agreement with us about the issues that were before the AAT, based on additional information that was obtained by the applicant after the appeal was lodged to the AAT. Both parties applied for, and were granted, consent orders to reflect the terms of that agreement.
For those matters that have been finalised, none of the outcomes of the AAT review were indicative of an issue about the quality of the initial or reviewable decisions made by us.
Self-assessed rating of performance against KPI 2 for 2015-16
The performance rating of "substantially" met is based on medical device timeframes not being met.
|Met||Substantially met||Not met|
|Strong performance against all of the measures under the KPI||
Strong performance against most of the measures under the KPI
|Poor performance against all of the measures under the KPI|