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TGA key performance indicators: July 2015 to June 2016
KPI 1 Regulators do not unnecessarily impede the efficient operation of regulated entities
KPI 1.1 Regulators demonstrate an understanding of the operating environment of the industry or organisation, or the circumstances of individuals and the current and emerging issues that affect the sector.
1.1a Number of TGA participations in industry formal stakeholder forums, including meetings and working groups and feedback received on TGA presentations.
Within the reporting period we participated in 81 formal stakeholder forums that included attendance and participation at industry events, hosting regulator workshops for stakeholders, staff speaking engagements and bilateral meetings with industry groups.
Examples of these interactions included:
- four stakeholder workshops in Sydney, Melbourne and Canberra in October and November 2015 to consult on communication strategies for implementing changes to medicine ingredient names. The workshops were attended by representatives from the pharmaceutical and medical software industries as well as by health professionals, consumers and other relevant government agencies
- bilateral meetings with nine peak industry bodies to discuss key policy issues, the fees and charges proposal for 2016-17, as well as several other subject specific meetings with each body
- in cooperation with medical device peak bodies, an information day for medical device sponsors in Canberra on 15 October 2015. Nearly 200 people from the medical device industry attended the event, which provided information on the regulatory life cycle for medical devices. Industry feedback indicated this was successful, and there has been significant traffic for the presentations posted on our website following the event (9,724 viewings)
- in cooperation with the Australian Self Medication Industry, presentations at multiple training seminars for advertisers designed to improve awareness and understanding of the legislative requirements that apply to the advertising of therapeutic goods
- regular working groups with industry (e.g. Regulatory Affairs Working Group with Medicines Australia and the Generic and Biosimilar Medicines Association - 9 October 2015 and 6 April 2016) to discuss inter alia the predictability and timeliness of the prescription medicine registration process through the provision and discussion of performance data
- participation in meetings with stakeholders in August 2015 (prescription medicines and medical devices) and December 2015 (complementary medicines and advertising) to explore industry priorities and issues relating to the Expert Panel Review of Medicines and Medical Devices Regulation.
Feedback from these interactions, including the above educational seminars and events, has resulted in other smaller face-to-face workshops, as well as increased participation in online education webinars.
1.1b Information on informal interactions with industry and how they are able to build understanding, for example ad hoc meetings between senior TGA staff and industry on specific issues and educational seminars for TGA staff on industry business activities.
We regularly engage with industry to provide guidance on a range of regulatory matters. During the period, these interactions included:
- convening discussions and providing support to sponsors on potential safety and performance issues
- working cooperatively with industry stakeholders by:
- providing direction on actions required for the finalisation of transition for joint replacement medical devices from class IIb to class III medical devices
- hosting informal meetings to discuss changes to the prescription medicines registration process. Discussions included shortening the pre-submission timeframes and minimising data requirements
- holding workshops in Sydney, Melbourne and Brisbane between November 2015 and February 2016 to inform stakeholders on the introduction of a new online submission system for Clinical Trial Notifications (CTNs)
- providing updates to laboratory stakeholders on the transition period for in-house in vitro diagnostic medical devices (IVDs) and advice on how to comply with regulatory requirements
- undertaking user testing of the web-based interfaces for the Special Access Scheme and Adverse Event Management System
- conducting Australian Public Assessment Reports (AusPARs), pre-submission pilot, and TGA Stakeholder 2015-16 surveys.
During these interactions our staff had the opportunity to improve their knowledge of emerging technologies, innovative products and priorities for the regulated industry. These activities also provided industry with an opportunity to increase its understanding of our regulatory requirements.
KPI 1.2 Regulators take actions to minimise the potential for unintended negative impacts of regulatory activities on regulated entities or affected supplier industries and supply chains.
1.2a Evidence of continued compliance with our practice of engagement with industry before a regulation impact statement (RIS) is finalised, to minimise the potential for unintended impacts on regulated entities and product supply.
We engaged with industry stakeholders prior to finalising RISs relating to the International Harmonisation of Medicine Ingredient Names and the Annual Charge Exemption Scheme, along with two sunsetting regulatory instruments that were remade with no changes. For more information see KPI 6.2a. This ensured that any unintended negative impacts were minimised.
KPI 1.3 Regulators implement continuous improvement strategies to reduce the costs of compliance for those they regulate.
1.3a Progress towards implementation of the Australian Government Digital Transition Policy.
Digital record keeping means that the majority of an agency's records will be created, stored and managed digitally and, where possible, incoming paper records will be scanned so that new paper files are not created.
Over the period, 75% of submissions for medicines, devices and biologicals were provided in electronic format. This figure has increased from 72% in June 2015.
A number of initiatives assisted in our transition to digital processes such as:
- the cessation of paper files project which will cease the production of paper-based files
- commencement of the pilot for an internationally standardised structure for conformity assessments for medical devices, known as the Table of Contents pilot
- coinciding with the implementation of electronic Common Technical Document (eCTD), we mandated requirements for industry to cease the production of physical data. This improved the quality of the e-submissions and validation process, and helped to streamline the assessment process
- other business improvement projects e.g. electronic form for minor variations to prescription medicines.
1.3b Progress of the strategies being implemented under the business improvement program and other specific projects aimed at reducing compliance costs for industry.
We have implemented a number of initiatives aimed at reducing compliance costs for industry. We launched the TGA Business Services website (enabling the regulated industry to view and pay invoices, maintain contact details, check the status of applications and respond to requests for additional information) and implemented paperless processes for three quarters of product billing and industry assistance functions (e.g. invoice requests, request for credit notes, write-off approvals).
Further initiatives included:
- we commenced receiving and managing eCTD submissions in addition to non-eCTD electronic submissions for prescription medicine applications. 100% of Category 1 applications (to register a new prescription medicine, other than an additional trade name, or make a variation to an existing medicine), were received electronically. The submission of hard copy dossiers for Category 1 applications is no longer required, resulting in significant savings for industry and the Department in avoided printing and storage costs
- a new corporate Ingredients Repository - a centralised source of ingredient and proprietary ingredient information, referenced by most systems at the TGA. In addition to being easier to maintain (through the auto-population of client details from a validated source), the new Ingredients Repository will improve the Ingredient Summary documents available via our eBusiness Services (eBS) public portal and reduce enquiries from industry stakeholders seeking clarification or additional information
- the ability to more easily develop smartforms through the acquisition and implementation of an eForm development tool
- the commencement of a new adverse event management system which, when completed, will improve processes and reporting
- the new Annual Charges Exemption (ACE) scheme, which has replaced and improved the previous low value turnover (LVT) scheme to exempt goods from annual charges on the basis of low sales turnover, took effect from 1 July 2015
- a pre-submission pilot pathway for prescription medicine applications was introduced in February 2016. The pilot aims to reduce the regulatory burden on industry by removing the need to provide summary information prior to lodgement of a submission for new prescription medicines
- development of policy and implementation design activities ahead of public release of the Government’s response to the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation.
|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|