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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
KPI 1 Regulators do not unnecessarily impede the efficient operation of regulated entities
|We met KPI 1 by undertaking extensive formal and informal consultation and participating in industry events. We implemented business improvements based on feedback we received through consultation with industry, resulting in less impost on industry in meeting regulatory requirements.|
|Most external validators concluded that our consultation activity demonstrated a good understanding of the operating environment of industry and allowed industry to provide formal feedback on matters of importance.|
|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.||
Over 100 formal stakeholder events and numerous informal events.
Increased our online engagement through webinars.
|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.||
Significant engagement through finalising two Regulation Impact Statements (up-scheduling of codeine and medicine labelling).
|KPI 1.3||Regulators implement continuous improvement strategies to reduce the costs of compliance for those they regulate.||
Improved performance against the Australian Government Digital Transition Policy.
Launch of initiatives that provide regulation clarity to stakeholders.
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.
Engagement with industry provides opportunities for us to identify and assess issues, respond to emerging risks and introduce change to stakeholders in a manner that does not impede their function. In 2016-17 we participated in over 100 formal stakeholder forums that included attendance and participation at industry events, regulatory workshops for stakeholders and bilateral meetings with industry groups.
We increased our online engagement through webinar meetings, providing a more accessible platform to engage with industry stakeholders irrespective of location. Six webinars were presented in response to topics requested by industry and on key consultations, with attendance ranging between 25 and 125. This improved our understanding of industry views. Feedback on these forums from industry participants and healthcare professionals has been consistently positive.
We are implementing a series of reforms to address MMDR recommendations and have undertaken consultation to inform tangible improvements in our regulatory practices, balancing industry needs with our responsibility to ensure the safety and efficacy of therapeutic goods. An example included a webinar to discuss the proposal to reformat Product Information (PI) documentation with feedback from over 70 industry participants influencing changes to the proposed new format of PIs. Industry lauded the success of these events and, based on this positive feedback, we are planning to increase our webinar engagement in future.
In late 2016, we held an information session and workshop with industry representatives on the proposed eligibility criteria and designation process for the Priority Review and Provisional Approval pathways and the Priority Review registration process. This was also an opportunity to discuss related reforms such as the Orphan Drugs program, the proposed Black Triangle Scheme, and changes to notifications for variations of prescription medicines. We held a further workshop in early 2017 focusing on the Provisional Approval pathway that involved industry, health professional and consumer representatives. These workshops assisted in developing the policy and business processes for the Priority Review and Provisional Approval pathways. Industry advice has informed many components of the projects, including development of guidance documents, changes to legislation, and the development of new fees.
We engaged in public and targeted consultation with industry on the development of the expedited pathways for prescriptions medicines and an e-Form for minor variations to prescription medicines. Three information sessions regarding the e-form for minor variations to prescription medicines were held to assist industry with navigating the new form and providing feedback on improvements to the e-form which we subsequently implemented.
We delivered 10 presentations and workshops to explain proposed complementary medicines reforms and inform stakeholders about timelines for reform projects well in advance of implementation.
We actively engaged with industry on the decision to up-schedule codeine from February 2018. In 2016-17 we coordinated six meetings of the National Coordinated Codeine Implementation Working Group, comprised of representatives from state and territory health departments and peak professional bodies representing consumers, pharmacists and health professionals. The Working Group agreed to a communication and engagement strategy and developed stakeholder education material for dissemination. We also held a forum in May 2017 to provide industry product sponsors with information on the up-scheduling changes and the implications for their current stocks.
We facilitated quarterly meetings with medical device peak bodies via the Regulatory and Technical Consultative Forum (Reg Tech) to prioritise and discuss issues of concern and propose solutions, including opportunities to improve current regulatory practices and compliance. Industry consultation and advice aided preparations for an information day for medical device sponsors. We held six workshops for sponsors of medical devices to provide education on their roles and post-market responsibilities. Industry feedback was positive and will inform future educational materials.
The TGA-Industry Working Group on Good Manufacturing Practice met three times in 2016-17. Members provided feedback on a range of Good Manufacturing Practice (GMP) issues including development of the Licensing and Certification Guidance document and GMP Clearance Guidelines which provide clarity on our regulatory processes.
Annual bilateral meetings were held in February 2017 with nine peak industry bodies to present our financial performance and discuss fees and changes proposals for 2017-18.
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 strive to maintain an open and transparent relationship with industry through frequent and informal engagement. Further information is available at KPI 2.2a. These interactions provide our staff with opportunities to enhance their knowledge of emerging issues, technologies, products and priorities. By maintaining an open dialogue with regulated entities we are better able to tailor our formal consultations and public information to address areas of concern.
In 2016-17, our informal interactions included:
- hosting meetings with industry to discuss changes to the scheduling of poisons and medicines and remaking of the Poisons Standard legislative instrument
- participation in a Complementary Medicines Regulatory Obligations Seminar, where four presentations were delivered to sponsors, manufacturers and regulatory affairs consultants on regulatory requirements and upcoming reforms to the regulatory framework for complementary medicines
- allowing sponsors extra time to update ARTG records in response to a compliance project for complementary medicines with biomarker indications, thereby reducing likely losses incurred by sponsors
- meetings to discuss licensing and certification of manufacturers and GMP clearance applications submitted by Australian sponsors
- a workshop with the Association of Regulatory Clinical Scientists (ARCS) on Risk Management Plans and pharmacovigilance in June 2017
- participation in an industry forum in May 2017 about the codeine re-scheduling decision.
We provided support to sponsors on potential safety and performance issues with respect to medical devices, including:
- facilitating regular industry presentations on device regulation which gave staff the opportunity to improve their knowledge of emerging technologies, innovative products and industry priorities
- ongoing updates to laboratory stakeholders on the transition period and regulatory requirements for in-house IVDs
- user testing of new web-based interfaces for Conformity Assessment applications
- provision of assistance to sponsors on the regulatory framework for medical devices via the medical device information line
- meetings with the Australian Red Cross Blood Service to discuss changed inspection frequencies, licensing of mobile sites and implementation of eSignatures on GMP licences.
In August 2016 we hosted an exhibition space at the ARCS Scientific Congress, attended by over 900 delegates from the therapeutics industry and clinical research organisations. This platform provided an informal opportunity for face-to-face engagement with industry representatives and clinical scientists who made ad hoc enquiries relevant to the regulation of therapeutic goods, and to gather input on the regulatory issues that impact on businesses.
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.
In 2016-17 we prepared two RISs, one on the up-scheduling of codeine and the other on medicine labelling. Both of these were found to be compliant by the Office of Best Practice Regulation. We engaged with industry stakeholders prior to finalising the RISs to ensure minimal impact on regulated entities and product supply. The RIS for the re-scheduling of codeine was supported by independent economic modelling conducted by KPMG.
Over the last 10 years stakeholders have alerted us to concerns about labelling and packaging of medicines, including the contribution of naming, labelling and packaging practices to the safety and quality use of medicines. A number of consultation processes have focussed on these concerns, most recently the Transparency Review, the Labelling and Packaging of Medicines Review and the Round Table on Safer Naming, Labelling and Packaging of Medicines.
On 9 August 2016, we announced new requirements for the presentation of information on medicine labels. The new requirements aim to make Australian medicine labels clearer and more consistent and consequently help to avoid medication errors. The new medicine labelling standards require greater prominence and consistent location of information on active ingredients, and specify new allergens to be declared on medicine labels. A four year transition period was provided to allow industry to adopt the label changes with minimal compliance costs.
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.
The Government's Digital Transition Policy plays a key role in supporting digital transformation initiatives and driving e-government. Digital recordkeeping 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.
We are well advanced with the transition to digital processes. During 2016-17 an estimated 90% of submissions for medicines, devices and biologicals were provided in electronic format. This figure increased from 75% in June 2016 and is expected to increase again in the next year. This created efficiencies related to unnecessary duplication, storage costs, easy access to information, and improvement in the delivery of services and response times.
The following initiatives assisted our transition to digital processes:
- internal education to reduce the creation of physical files to meet Digital Continuity 2020 targets
- completion of four digitisation projects
- development of the Prescriptions Medicines minor variation e-form
- completion of the Information and Records Management Strategy.
These initiatives have facilitated end to end digital work processes which provided more mature and efficient services, enabling better productivity and responsiveness to industry.
1.3b Progress of the strategies being implemented under the business improvement program and other specific projects aimed at reducing compliance costs for industry.
During 2016-17 we implemented a number of initiatives through the Business Services site, aimed at reducing compliance costs for industry. These included:
- development of a new online Conformity Assessment application form for medical devices for implementation in 2017-18
- implementation of a new Conformity Assessment Certificate Repository which will facilitate the automatic generation of certificates at the conclusion of a Conformity Assessment application
- development of a new Adverse Event Management System (AEMS) to support both medicines and medical device adverse events, which will be launched in the next reporting period
- launch of a Prescription Medicine Minor Variation e-Form to permit electronic lodgment of forms and supporting evidence for minor variations in prescription medicines.