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TGA key performance indicators: July 2015 to June 2016
KPI 4 Compliance and monitoring approaches are streamlined and coordinated
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 implement processes to minimise the number of formal requests for information from regulated entities by improving our business processes.
During the reporting period, we worked with the complementary medicines industry to create electronic forms that clearly communicate the requirements of each application category. This is expected to minimise the need for us to seek additional information.
Reform activities have also been introduced over this period to streamline the prescription medicine application processes and engage with sponsors prior to submitting their applications. One of the key elements was the consolidation of regulatory requests issued under section 31 of the Therapeutic Goods Act 1989 at a single stage in the evaluation process. This has reduced the number of requests sent to sponsors during the evaluation process.
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.
Other activities included:
- changes were implemented to streamline systems and processes for registering complementary medicines though the alignment of systems with OTC medicines, and reduce effort, including requests for information, by the consideration of comparable evaluations as part of applications
- streamlined post-market review processes were developed which improve the timeliness of compliance reviews for listed complementary medicines and reduce requests for information within the review process
- a pilot of a simplified pre-submission pathway for prescription medicine registration applications removes the requirement for sponsors to provide summary information to us during the pre-submission phase and then again with the submission dossier. This information is now provided once, in the submission dossier only.
4.2b Information on cooperative activities carried out with international regulators to minimise information collection from industry (such as joint GMP inspections).
We regularly share manufacturer inspection schedules with the United States of America’s Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada. This activity aims to identify opportunities for joint inspections with international regulators and therefore minimise the burden on industry. Nine joint GMP inspections were conducted during this period, with agencies including the EMA, EU member state regulators, the European Directorate for the Quality of Medicines and Healthcare (EDQM), the US FDA, Medsafe New Zealand, Health Canada and Medicines Control Council of South Africa.
Collaboration on generic medicines for the reporting period resulted in agreement of a common template for Drug Master Files, new ingredients code tables for eBusiness Services (eBS) and revised guidelines on biosimilar medicines. We also published two OTC medicine monographs that were developed with Health Canada. This will enable more OTC medicines to be processed requiring less information to be provided in the application for registration.
We also have an active role in the development of the international model for a Medical Devices Single Audit Program (MDSAP) through the IMDRF. The pilot is intended to allow 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 pilot program.
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 have strong active working relationships with major overseas regulators including the United States, Canada, New Zealand, Singapore and European countries. Information sharing with international regulators is further facilitated through participation in forums and consortia such as the International Coalition of Medicines Regulatory Authorities (ICMRA), International Generic Drug Regulators Program (IGDRP), the Australia, Singapore, Switzerland, Canada (ACSS) consortium, International Conference on Harmonisation of Technical Requirments (ICH) and the Regulatory Cooperation Initiative (RCI) with Health Canada.
Examples of collaboration and information sharing with other regulators during the reporting period include:
- chairing the ICMRA Generic Medicines Working Group that developed a draft policy paper proposing information sharing priorities for regulators on generic medicines
- chairing the ICMRA pharmacovigilance working group to progress work in three key areas:
- how to best utilise 'big data' for pharmacovigilance purposes
- increasing the rates of adverse event reporting, in particular from health care professionals; and
- linking existing systems in order to improve global pharmacovigilance warnings information sharing
- adopting the IGDRP evaluation templates for our assessment of Biopharmaceuticals Classification System-based biowaivers and Active Substance Master Files/ Drug Master Files to streamline the submission requirements for the medicines industry
- commencing a generic medicine work sharing trial with other regulators in the ACSS consortium and a leading industry stakeholder
- use of foreign review information in assessments of domestic generic drug/medicine applications. Eight generic medicine submissions and four drug master file reports were received from a foreign regulator
- undertaking desktop clearances for manufacturers in place of inspections, taking into consideration regulatory decisions by other comparable regulators. Of the 2,725 approved clearances, 2,590 (or 95%) were based on evidence from other regulatory agencies.
4.3b Collaborative work undertaken with health professionals. For example, interactions on significant medicine shortages, recall actions or safety issues.
At the request of the Council of Australian Governments (COAG) Health Council, we established a working party on medicines shortages. The working party consists of jurisdictional, professional and pharmaceutical industry representation, with the purpose of developing additional strategies to improve the management of medicine shortages. The working party developed the following recommendations for COAG Health Council consideration:
- improve awareness of the Medicine Shortages Information Initiative (MSII) and ensure the shortages are notified to the MSII in a more timely and comprehensive manner, with information kept up to date
- more proactively identify alternative sources of supply of suitable medicines
- ensure appropriate clinical advice is provided when there is a medicine shortage that will significantly affect patient care
- review procurement strategies and protocols on dealing with medicine shortages to ensure consistency in the public health sector
- notification of medicine shortages remains voluntary (with information published on shortages when a pharmaceutical company will not report the shortage).
Further activities include:
- collaboration with ACT Health and NSW Health in undertaking the "inSite" pilot project to educate health professionals about medical device adverse event reporting and encourage reporting to us
- in conjunction with ARCS Australia, several workshops for industry on activities to improve the quality of risk management plans.
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 outlines the activities undertaken to ensure that a risk-based approach is taken to our monitoring and compliance activities.
In addition to these activities, we have streamlined and coordinated compliance activities so that the circumstances and operational needs of industry are also considered. Information gathered from monitoring and surveillance activities is shared with pre market areas and inspectors. This information is subsequently used in risk assessments for activities such as proactive compliance reviews of therapeutic goods and schedules for inspections of manufacturing facilities.
A Regulatory Intelligence Section has been established to develop and implement strategic, tactical and operational intelligence capability. This intelligence capability is intended to provide intelligence led, risk-based predictive intelligence to support proactive compliance, enforcement and investigatory activity.
Self-assessed rating of performance against KPI 4 for 2015-16
We have self-assessed the result as "substantially" rather than "fully" met as TGA does not yet have a fully mature compliance and enforcement framework with graduated sanctions and penalties. While we have a sound compliance structure in place, we do not yet have a range of regulatory tools which allow us to use the full range of compliance approaches.
|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|