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Regulator Performance Framework: Self-assessment Report, July 2016 to June 2017
KPI 4 Compliance and monitoring approaches are streamlined and coordinated
|The self-assessment rating of substantially met is based on our maturing compliance and enforcement framework. We have established an intelligence team, and are improving our investigations and enforcement capability, while working towards better regulatory tools to provide a robust sanction and penalty regime.|
|Our external validators provided mixed views on our self-assessment rating, noting that enhanced compliance and enforcement powers need to be coupled with improved compliance and monitoring systems.|
|KPI 4.1||Regulators' information requests are tailored and only made when necessary to secure regulatory objectives, and only then in a way that minimises impact.||
Improved guidance provided to assist with initial provision of information.
Voluntary compliance encouraged by seeking information through informal mechanisms.
|KPI 4.2||Regulators' frequency of information collection is minimised and coordinated with similar processes including those of other regulators so that, as far as possible, information is only requested once.||
Streamlined and coordinated approach to capturing compliance information.
Working towards international convergence.
Sharing manufacturing inpsection schedules with international regulators and joint GMP inspections.
|KPI 4.3||Regulators utilise existing information to limit the reliance on requests from regulated entities and share the information among other regulators, where possible.||
Chairing and coordinating the Medicine Shortages Working Party.
Driving collaboration between Commonwealth, state and territory bodies.
|KPI 4.4||Regulators base monitoring and inspection approaches on risk and, where possible, take into account the circumstance and operational needs of the regulated entity.||
Enhancing post market monitoring to support a wider range of product approval pathways, making products available earlier.
KPI 4.1 Regulators' information requests are tailored and only made when necessary to secure regulatory objectives, and only then in a way that minimises impact
4.1a Information on activities undertaken to minimise the need for, or number of, requests for information to sponsors under the relevant legislation.
We continually identify ways to improve our processes to minimise the number of formal requests for information made to regulated entities. We have improved the way we communicate with sponsors of new registered complementary medicines and new ingredients for use in listed medicines. We encourage sponsors of complementary medicines and new listed medicine ingredients to attend pre-submission meetings before submitting applications. This has allowed us to provide tailored advice and clarify the regulatory requirements.
When conducting compliance reviews, we encourage voluntary compliance by seeking information through informal mechanisms. Previously we issued formal notices to commence compliance activity. We now work to gather information we hold prior to contacting sponsors. This saves time for both sponsors and the TGA.
Our Investigation Unit undertakes informal liaison with sponsors when preparing responses to safety-related issues and requests information under the Therapeutic Goods Act 1989 only when necessary. This liaison typically reaches satisfactory outcomes and formal requests for information are rare.
We have developed a new Clinical Evidence Guideline for Medical Devices which provides robust regulatory guidance that clearly communicates pre and post market requirements. This guidance was developed by working with the medical devices industry to pre-empt queries and address areas of confusion and to provide greater clarity and consistency for our own evaluators.
We are continuing to reform our business practices and data storage to make information more accessible and minimise the impact on sponsors from information requests in cases where we may already hold the required information.
KPI 4.2 Regulators' frequency of information collection is minimised and coordinated with similar processes including those of other regulators so that, as far as possible, information is only requested once
4.2a Refer to KPI 1.3 – (Progress of business improvements, and other specific projects, so that sponsors will only need to provide some information to the TGA once).
Initiatives to collect information from sponsors, including the new TGA Business Services site, are captured under various business improvement programs as outlined in KPI 1.3b.
4.2b Information on cooperative activities carried out with international regulators to minimise information collection from industry (such as joint GMP inspections).
We are heavily engaged in the international regulatory community. Our strong relationships allow us to capitalise on the learnings of other therapeutic goods regulators and to lead regulatory improvement.
We regularly contribute to a system of sharing manufacturer inspection schedules with the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), Health Canada and Pharmaceutical Inspection Cooperation Scheme (PIC/S) participating authorities. This activity identifies opportunities for joint inspections with international regulators and minimises burden on industry. We continue to focus on collaboration with other regulators to develop internationally recognised policies and share information that will reduce industry burden through harmonisation of regulatory requirements.
Nine joint GMP inspections were conducted in 2016-17 with agencies including the World Health Organization, the United Kingdom's Medicines and Healthcare Products Regulatory Agency, Health Canada and the US FDA. We contributed to the review of PIC/S strategies and policies as part of the participation in PIC/S working groups, aiming for mutual recognition of decisions on GMP inspections. We also continued to collaborate with Health Canada under the Regulatory Cooperation Initiative program focusing on joint inspections and desktop assessment processes.
We have an active role in developing the international model for a Medical Devices Single Audit Program (MDSAP) through the International Medical Device Regulators Forum (IMDRF). The program allows MDSAP recognised auditing organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the multiple regulatory authorities participating in the program.
As part of the TGA's program of pharmacovigilance activities, we regularly engage with other international regulators. Discussions are held with the International Post-Marketing Surveillance Teleconference, which is held bimonthly with the US FDA, Health Canada, New Zealand's MedSafe, the Health Sciences Authority Singapore and Swiss Medic and is co‑chaired by the TGA. We also participate in teleconferences with New Zealand's MedSafe to discuss current safety issues and share information. As part of the International Coalition of Medicines Regulatory Agencies we are involved in exchanging experiences and knowledge about the use of health data sets and social media in safety monitoring. In some circumstances these information-sharing activities can help to minimise the need to collect certain information from industry.
We are on the Permanent Forum on International Pharmaceutical Crime management committee. This international enforcement forum protects public health through the exchange of information on crimes and trends and ideas to foster mutual cooperation.
KPI 4.3 Regulators utilise existing information to limit the reliance on requests from regulated entities and share the information among other regulators, where possible
4.3a The use of information from, or in collaboration with, other regulators; for example, development of processes for sharing with international regulators, the number of product evaluation and inspection reports shared.
We maintain active working relationships with overseas regulators through participation in forums and consortia and we continue to expand our international network. Through the MMDR reforms, we are exploring opportunities to increase efficiency and reduce duplication by reducing assessment times for therapeutic goods and streamlining assessment processes between countries.
In 2016-17 we focused on maximising efficiencies in the assessment of therapeutic goods by continuing the generic medicine work sharing trial with other regulators in the Australia, Singapore, Switzerland, Canada (ACSS) consortium. We designed and shared assessment documentation for Complementary Health Products with ACSS and initiated work sharing opportunities for assessing new chemical entities with Health Canada.
We also worked towards streamlining formal information sharing between medicines regulators. The International Generic Drug Regulators Program (IGDRP) has undertaken a number of activities to promote collaboration and convergence amongst international regulators. We actively participate in working groups to align regulatory requirements internationally and minimise duplication for industry, such as:
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Reproductive Toxicity Working Group
- International Pharmaceutical Regulators Forum Cell Therapy Working Group
- ACSS Generic Medicines Working Group.
We undertake desktop GMP clearances for overseas manufacturers in place of inspections, taking into consideration regulatory decisions by comparable regulators. Of the approved clearances during the reporting period, 92% were based on evidence from overseas regulatory agencies.
Formal processes for the use of international reports in the assessment of complementary medicines and ingredients for use in complementary medicines were designed in 2016-17 and will be implemented in the coming year. In the long term, this work will benefit industry by providing additional flexibility in the data that can be provided in support of applications.
We have continued to develop our work sharing arrangements with other international regulators for new chemical entities, generic medicines, pharmacovigilance and adverse events reporting under ICMRA. We also completed a pilot work sharing project with Health Canada in Periodic Safety Update Report evaluation.
Our involvement in IMDRF working groups on: Improving the quality of international medical device standards for regulatory use; Adverse Event Terminology; Good Regulatory Review Practices; Software as a Medical Device; Review of the National Competent Authority Report Exchange Program; and Regulated Product Submissions will enable consistent global standards, minimising the burden on Australian industry.
4.3b Collaborative work undertaken with health professionals. For example, interactions on significant medicine shortages, recall actions or safety issues.
The TGA chairs the Medicine Shortages Working Party with state and territory health departments, health professional bodies and industry associations to facilitate better communication relating to medicine shortages and dissemination of timely information. We also participate in quarterly meetings with the US FDA, Health Canada, the UK MHRA and the EMA to exchange information on current medicine shortages and processes to minimise their effects and ensure awareness of global shortages that may affect Australian health professionals.
We contact industry regarding medicine shortages to obtain current and accurate information about product inventory. This information is required to assist in answering enquiries from health professionals. We continue to work with industry to provide information on medicine shortages through the Medicine Shortages Information Initiative on our website. We have approved the supply of alternative medicines to health professionals where there is a significant medicine shortage.
Further interaction with the Medicines Shortages Working Party is anticipated following departmental resolution of strategic issues.
We collaborated with ACT Health and NSW Health in undertaking the medical device incident reporting and investigation scheme (IRIS inSite). The IRIS inSite program works closely with health facilities to improve awareness amongst health professionals about medical device adverse event reporting. The program has had a positive impact on the frequency, rate and quality of reports received and consequently our ability to safeguard therapeutic goods in Australia.
The TGA's Chief Medical Adviser works closely with the Commonwealth's Chief Medical Officer, the Clinical Director of the Australian Commission on Safety and Quality in Health Care and the Chief Health Officers of the states and territories to ensure a consistent approach to problems which may develop with medicines and devices.
KPI 4.4 Regulators base monitoring and inspection approaches on risk and, where possible, take into account the circumstance and operational needs of the regulated entity
4.4a Refer to KPI 3.3 – Information on activities undertaken to ensure that a risk-based approach is taken to monitoring and compliance activities.
KPI 3.3 provides detail of the activities undertaken to ensure we use a risk based approach to monitoring and compliance activities. We continue to work towards greater cohesion across compliance and monitoring functions, and the maturation of our intelligence function.
Further activities have been undertaken as part of the MMDR reforms which included enhancing post-market monitoring for medicines and medical devices. The program will deliver a range of new and enhanced post-market monitoring capabilities to enable us to proactively minimise, detect and address medicine and medical device safety issues. The capabilities span data analytics, international work and information sharing, adverse event reporting, and compliance. It will provide us with better information about emerging safety issues.