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TGA key performance indicators: January to June 2015

Version 1.0, August 2015

3 September 2015

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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.

7.1 Participation in international harmonisation activities
Good Manufacturing Practice inspections

Contributed to a review of Pharmaceutical Inspection Cooperation Scheme (PIC/S) strategies and policies, as the basis for mutual recognition of decisions on Good Manufacturing Practice (GMP) inspections.

Continued regular sharing of inspection schedules with the United States of America's Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and Health Canada, with a view to identifying opportunities for joint inspections.

Conducted nine joint GMP inspections with other regulatory agencies, including the EMA, European Union (EU) member state regulators, the European Directorate for the Quality of Medicines and Healthcare (EDQM), the US FDA, Medsafe New Zealand, Health Canada and the Medicines Control Council of South Africa.

International Medical Devices Regulators Forum (IMDRF)

National Competent Authorities Report Exchange Program: In March 2015 updated guidance was published on the exchange of reports about serious public health issues between IMDRF members.

Regulated Product Submission: Comprehensive Tables of Contents (ToC) have been established for in vitro diagnostic (IVD) market authorisation and non-IVD market authorisation. Planning for further piloting of the ToCs is underway, with a focus on the development of supporting documents. The pilot plan was publicly released as an IMDRF information document.

Software as a Medical Device (SaMD): Draft guidance was released for consultation on the application of existing, standardised and generally accepted quality management system practices to SaMD.

Medical Device Single Audit Program (MDSAP): An assessment and decision process for the recognition of MDSAP Auditing Organisations has been developed. Two guidance documents are currently under development-guidance on regulatory authority assessment methods of auditing organisation's processes and medical device regulatory authority audit reports. The TGA is actively participating in the MDSAP pilot, including the auditing organisation assessment process.

Medical Device Patient Registries: Work commenced on work items for integrating device registries, Unique Device Identification and innovative tools for medical device evaluation.

Adverse event coding for medical devices: Work commenced on the development of common terminology and code related to adverse events involving medical devices.

International Generic Drug Regulators Programme (IGDRP)

Continued participation in the pilot IGDRP-EU Decentralised Procedure and EU Centralised Procedure for the evaluation of generic medicine applications.

Incorporated the IGDRP evaluation templates for TGA assessment of Biopharmaceutics Classification System-based biowaivers and Active Substance Master Files/Drug Master Files. The working groups are now reviewing their mandates and workplans for the next direction in work sharing.

As the IGDRP Secretariat, the TGA developed a website for the IGDRP's public face, finalised the Terms of Reference for the next two years of the group and established a new working group to address IT business needs for the IGDRP and its working group.

International Coalition of Medicines Regulatory Authorities (ICMRA)

Participated as a member of the ICMRA Interim Management Committee where, among other things, regulators established a clear strategic framework to clarify the role of the ICMRA and better articulate its value-add across global initiatives.

As the project lead, finalised the draft protocol for sharing information between ICMRA partners to allow for worksharing, particularly in relation to the pre-market authorisation for generic medicines and data requirements for mutual recognition of GMP inspections.

Direct collaboration with other regulators

Generic Medicines

Continued collaboration with Health Canada, the Health Sciences Authority of Singapore and Swissmedic to develop simplified information sharing programmes to facilitate work sharing for assessment of Drug Master Files (DMF) in each country. Finalised DMF quality assessment report template, which is currently being used by all four agencies.

Facilitated communication with selected generic companies for a pilot project to support genuine worksharing between the four agencies, which is based on the EU Decentralised Procedure. Project likely to begin in March 2016 (based on available submissions that meet the criteria).

Continued information sharing with Health Canada in the area of pre-market assessment of generic medicines as business-as-usual through the routine exchange and utilisation of evaluation reports.

Orphan Medicines

Continued to monitor opportunities to enhance collaboration and information sharing regarding assessment of orphan medicines with other regulators.

Collaborative arrangements

Finalised new collaborative arrangements with Medsafe (New Zealand) and the Paul Ehrlich Institut (Germany) that allow for sharing of a broad range of confidential information to support our regulatory functions and underpin future collaborative activities.

Continued work to finalise new collaborative arrangements with Swissmedic, the French Agency for the Safety of Health Products (ANSM) and US FDA to enhance collaboration and information sharing, including the exchange of information such as assessment reports on orphan drugs.

Continued discussions with European regulators to enhance confidence in medical device assessments completed in Europe.

7.2 Collaboration and work-sharing with other regulators
Collaboration and work-sharing with other regulators Jan - Jun 2015 Jul - Dec 2014 Jan - Jun 2014
Exchange of bioequivalence reports1 to support generic prescription registration 12 17 0
Number of monographs developed with Health Canada to support non-prescription medicines registration2 2 0 0
Number of desktop clearances for manufacturers undertaken in place of inspections, taking into consideration regulatory decisions by other comparable regulators.3 2144 1941 1481

Work sharing and single inspections under the Medical Devices Single Audit Program (Pilot MDSAP).

As it is still in pilot phase, inspections under the MDSAP are yet to commence.4

N/A N/A N/A
Number of post-market signals for prescription medicines received from international regulators during the reporting period to trigger appropriate early warnings. 0 1 0
  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.
  3. 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
  4. Approximately 95-98% of overseas manufacturer clearances are issued via desktop assessments that take into account overseas regulatory decisions.
  5. 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.
  6. N/A = not applicable.

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