We demonstrate our performance against this KPI in three different areas, as described below.

For this reporting period, website statistics are split into two separate time periods because we upgraded our reporting software in November 2014. There is a difference between how the reporting software captures and analyses the data and therefore there is not a direct correspondence between the new metrics and visitor numbers reported in previous periods.

N/A = not applicable. This webpage was created during the current reporting period.

1. Several TGA speakers may have presented at a single forum.

Market research on our stakeholders

Consumers, health professionals and industry are surveyed annually to measure whether there are improvements in stakeholder understanding of our role. The next survey will be conducted in late 2015 and therefore no new data is available for this period.

TGA stakeholder consultation

1. We aim to publish consultation submissions and the TGA response (where appropriate) within two weeks of noting or advice from the Assistant Minister for Health, where applicable.
2. Submissions and responses to one consultation were published during the reporting period.
3. N/A = Not applicable. This survey is conducted on an annual basis.

Stakeholder satisfaction with TGA consultation processes decreased during this reporting period due to shorter timeframes provided for consultation responses, and reduction in advanced notice of consultations due to the unavailability of the consultation forecast during the conduct of the Expert Review of Medicines and Medical Devices Regulation.

TGA customer service

The Regulatory Assistance Section (RAS) is our first point of contact for enquirers approaching the TGA. Under the TGA's customer service standards, the RAS aims to respond to voicemail messages within two working days, and to respond to emails (either through a direct response or referral to regulatory areas for appropriate action) within five working days.

Figure 1 Regulatory Assistance Section performance

Enquiries received by the RAS are separated into levels depending on how the enquiry is managed:

• RAS responded with input: enquiries that require more than one transaction to finalise, where a response sent by RAS includes input from other regulatory/business areas.
• RAS responded: enquiries finalised by the RAS without needing advice from other areas as the information is publicly available or a similar enquiry has been responded to in the past with appropriate clearance.
• Referred to business areas: Enquiries that are transferred to other work areas for follow up and response.

There were 1955 voicemail messages received during this period. This is an increase from the previous period as a result of staff turnover and training, however the RAS responded to 100 per cent of email and voicemail enquiries within the specified timeframes during the reporting period.

The TGA customer service standards specify that feedback will either be answered or acknowledged within 5 working days and, where feedback requires further investigation by the TGA, the acknowledgement will provide notification of this and associated timeframes for response.

The TGA makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia. This KPI provides evidence about whether we are enabling timely access to therapeutic goods for the Australian public.

We aim to ensure that all of the applications for market authorisation of therapeutic goods are processed within target timeframes. There are different targets in place for the time taken to make a regulatory decision, depending on the type of therapeutic good. Some of these targets are specified in the legislation. Timeframes exclude 'hold times' where the TGA is awaiting a response from an applicant following a request for information, and includes any time for committee consideration.

1. Data for new and change applications were reported differently prior to 2014. The data reported are the total number of applications completed during the reporting period and the percentage that were completed within target timeframes. Further details of the different types of applications for non-prescription medicines are available in the Australian Regulatory Guidelines for Non-prescription Medicines. The different application types for non-prescription medicines are:
   • N1: an application submitted as a 'Clone'
   • N2: an application which complies with an over-the-counter medicine monograph
   • N3: a new application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4
   • N4: an application for a 'generic' medicine where the medicine:
     • is included in Appendix X of the Over-the-counter Application Categorisation Framework (but which is not a level N1 application) and/or
     • includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher level of assessment and/or
     • requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data.
   • N5: an application for a new product that is an extension to a 'Generic category' product or an application for a product containing a new chemical entity as an active ingredient.
   • C1: quality and non-quality changes - self assessable requests and safety related requests
   • C2: quality changes or non-quality changes - no safety and efficacy data required
   • C3: umbrella branding - higher level of assessment or non-quality changes - safety and efficacy data may be required
   • C4: non-quality changes - data are required.
2. There were no approvals for this application type during the reporting period.
3. These data are for a single application.
4. There were three applications approved, which were different dosage forms of the same product line. Thus, the average time for completion of the three individual applications is divided by 3 for reporting purposes.
5. The audit period commences when the sponsor is notified that the application is selected for audit. Previously, due to certain limitations the target timeframe in this report was calculated inclusive of the 20 working days period from when the application is made (application fee paid) during which time the TGA may select the application for auditing. The figures for the last 6 months (January - June 2015), the report refers to the actual audit time, i.e. excluding initial 20 working days prescribed under the legislation.
6. The figures for non-compulsory audits do not include applications for reclassification of total or partial shoulder, hip, or knee joint replacement medical devices. These applications are not subject to the agreed target timeframe.
7. The January-June 2014 figure incorrectly includes numbers for Joint Implant Reclassification applications that are not subject to the agreed target timeframe. The correct figures are: there were 225 non-compulsory application audits processed in January to June 2014, of which 32% were completed within the 30 TGA working day target time frame.
8. The intricate nature of these audits vary considerably and during this reporting period the majority of audits undertaken were of significant complexity.

This indicator demonstrates whether TGA's work supports the continued availability of therapeutic goods on the Australian market that are safe, effective and of high quality. The success of many of these measures is underpinned by reporting of adverse events by consumers, health professionals and industry.

3.1 Product cancellations

Figure 2 Cancellations by the TGA of products following a compliance review

The number of listed medcines cancelled in the July-December 2014 reporting period is higher than comparative periods due to a single sponsor of 36 products failing to comply with a notice requiring information about the goods.

3.2 Medical device incidents

Figure 3 Triage and investigation of medical device incidents

Due to the complex nature of some investigations, it is not expected that all investigations would be completed within the 90 day target. For example, delays can occur while waiting on input from third parties.

3.3 Other post-market activities

1. This indicator relates to complaints about the advertising of therapeutic goods that are received via the Complaints Resolution Panel.
2. In this period, compliance with the advertising requirements was achieved without issuing a formal Regulation 9 Order.
3. The target timeframe for initial review of Class I and II recalls is two working days.
4. There were no actions relating to recalls for biologicals during the reporting period.
5. There were no actions relating to safety issues identified through targeted or random review during the reporting period.
6. The target timeframe for risk assessment and triage of safety signals for medicines, biologicals and medical devices is 30 days.

This indicator measures whether we are able to attract, develop and retain a professional workforce that can respond to current and emerging regulatory needs.

1. Sixteen positions were advertised during this period, eight of which were filled before 30 June 2015. These positions include positions that were advertised internally within the Department of Health, within the Australian Public Service, and some specialist positions that were open to eligible members of the community.
2. Ad hoc messages are also sent directly to staff outside these two channels as the need arises.
3. TGA weekly editions are not published during the peak holiday periods after Christmas or over the Easter period. We use other internal communication methods, such as the TGA Daily, to maintain continuity of internal communications.

Figure 4 Surveys of staff satisfaction with the TGA and the work they do

TGA staff are surveyed annually. The previous indicator titled "percentage of staff that agree that the work they do is important for public health" is no longer measured in the staff survey and therefore has been removed from this report.

*Of the 506 survey respondents in 2015, 29% of TGA staff provided a neutral response to this survey question.

TGA's activities are primarily cost recovered from industry. However, the TGA received appropriation funding in 2014-15 for aligning Australia's and New Zealand's regulation of therapeutic goods. The function of administering compliance frameworks for controlled drugs was transferred to the TGA Group of the Department of Health in August 2014 and continues to be funded from the departmental appropriation. As a result, TGA now has multiple funding sources for its activities. These activities contribute to Outcome 7 'Health infrastructure, regulation, safety and quality' and Outcome 9 'Biosecurity and emergency response' in the Department of Health's Portfolio Budget Statements.

This indicator on our financial performance shows that we are within the target budget range when compared to budget.

Note: target budget variance is ±5%.

Revenue for the full year was in line with budget overall although annual charges were below budget due to the transition arrangements for the new Annual Charges Exemption scheme and a higher rate of Low Value Turnover applications received during the year. Offsetting this were above-budget application fees and additional appropriation for administering compliance frameworks for controlled drugs.

Expenditure was below budget, mainly in employee expenses due to lower than budget staffing levels and no change in staff pay rates from last financial year.

1. N/A = not applicable. Financial audits are undertaken annually, at the end of June.
1. Unmodified means that the auditor expressed an opinion that financial statements were presented, in all material respects, in accordance with applicable financial reporting framework.

1. A decision on access to information must normally be advised within 30 days of receipt of the freedom of information request. However, this timeframe may be varied in certain defined circumstances by TGA or the Information Commissioner.
2. The Australian Government's Digital Transition Policy aims to move all Government agencies to digital recordkeeping. This is an average figure across various product streams on applications and submissions. TGA's target is 100% by December 2015. Compliance is as high as 99% for two of the submission types at 30 June 2015.
3. Zero (0) Regulation Impact Statements were completed in this period.
4. Six (6) Cost Recovery Impact Statements were completed in this period.

TGA has strong active working relationships with most major overseas regulators. These relationships help us safeguard public health in Australia through harmonisation, information sharing and cooperation.

Many of our efforts towards international cooperation are achieved by collaboration with international regulators through formal forums and consortia.

1. We continue to monitor this opportunity for work sharing, particularly regarding some aspects of the biopharmaceutic assessment report in circumstances where the bioequivalence studies submitted to Health Canada and TGA are performed at the same clinical sites and the bioanalysis is done by the same bioanalytical laboratory.
2. Opportunities for harmonisation efforts in other related areas continue to be explored, including Biopharmaceutic Classification System-based biowaivers.
2. In the period January - June 2015, we jointly developed monographs for dextromethorphan in oral antitussive preparations, and docusate sodium and/or sennosides in oral laxative preparations
3. Approximately 95-98% of overseas manufacturer clearances are issued via desktop assessments that take into account overseas regulatory decisions.
4. We continue to participate in the development of documentation for MDSAP pilot policy and procedures. We intend to incorporate outputs from audits performed by auditing organisations into our business processes to reduce duplication of audits and cost to sponsors.
5. N/A = not applicable.

Internal reviews are undertaken when someone affected by a decision requests a review of the decision by the TGA under Section 60 of the Therapeutic Goods Act 1989. In some cases, external review of TGA decisions by the Administrative Appeals Tribunal (AAT) is requested.

1. The data reported are the number and percentage of decisions subject to internal review.
2. Additional information was provided to the internal review delegate in all four cases where the initial decision was revoked or revoked and substituted. All internal reviews during the reporting period were completed within target (legislated) timeframes.
3. Three matters referred by sponsors to the AAT were decided during the reporting period. This figure includes substantive regulatory decisions:
   • to not include products on the Register
   • to remove products from the Register
   • to grant or revoke a manufacturing licence or conformity assessment certificate.