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TGA presentation given at the ARCS Pharmacovigilance Interest Area meeting, 17 November 2015

Presentation: Exploring information exchange opportunities between Industry and the TGA

27 November 2015


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Warren Arndt and Richard Hill, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration
  • Presented at: ARCS Pharmacovigilance Interest Area meeting, 17 November 2015
  • Presentation summary: The TGA is undertaking the AEM project as part of a wider business improvement programme. This presentation provided a brief overview of the project objectives and implementation plan.


Exploring information exchange opportunities between Industry and the TGA

Dr Richard Hill and Warren Arndt
Pharmacovigilance and Special Access Branch

ARCS PV Teleconference, 17 November 2015

Slide 1 - Contents

  • TGA's Business Improvement Programme
  • Background
  • Adverse Event Management project
  • What's next?
  • How to register
  • Questions and Answers

Slide 2 - TGA's Business Improvement Programme

The TGA is currently undertaking a programme of reform to ensure that it remains adaptable to both industry and community expectations.

A Business Improvement Programme (BIP) has been established within the TGA to improve the efficiency and effectiveness of the services provided by the TGA.

The programme includes significant Information and Communications Technology (ICT) improvements that will support the needs of both the TGA and the stakeholder community, now and into the future.

The TGA has started an Adverse Event Management (AEM) project under BIP to improve the current business systems and processes.

Slide 3 - Background

  • The TGA has separate systems for the collection and processing of adverse event reports.
  • The Adverse Drug Reaction System (ADRS) is used for medicines and vaccines.
  • The Incident Reporting and Investigation Scheme (IRIS) system is used for medical devices.

Slide 4 - Adverse Drug Reaction system

  • ADR data collection began 1964
  • The ADRS system uses:
    • Lotus Notes interface for data entry
    • Oracle data repository
  • There are over 350,000 individual reports in the database.
  • These reports have been received from sponsors, health professionals, state and territory government and consumers.

Slide 5 - Volume of medicine and vaccine reports

Origin of adverse event reports received by the TGA (2010-2014)

Graph showing the number of adverse events reports to the TGA, yearly since 2010. Sponsors provide over 50 percent of reports, followed by state and territory governments at approximately 30 percent

Sponsors provide over 50 percent of reports, followed by state and territory governments at approximately 30 percent

Slide 6 - How reports are received in ADRS

  • Email*, fax and mail
  • Telephone i.e. via Adverse Medicine Event Line (NPS) - consumers
  • Online forms on TGA website
    • Unregistered users
    • Registered users
  • ADRS Web Service

* Includes emails with E2B structured xml files

Slide 7 - Adverse Event Management project


The scope of the AEM project includes all therapeutic products (medicines, vaccines, biologicals and medical devices) for the following activities:

  1. The collection and processing of adverse event and problem reports
  2. The analysis of information to detect safety signals
  3. The review of safety signals identified from adverse event data and other information sources
  4. Associated reporting requirements to support the above activities

Slide 8 - Adverse Event Management project

Key business objectives

  • Improve the data quality, exchange and reporting of adverse event information
  • Streamline the processing of adverse event information
  • Reduce the regulatory burden for mandatory reporters of adverse event information
  • Improve the signal detection and management capabilities

Slide 9 - Adverse Event Management project

Expected benefits

  • Improved user experience for reporters of adverse event information
  • Efficiency gains in processing adverse event reports to handle the continual increases in volume
  • To ensure all reports are collected and stored in a structured format that aligns with international standards to support data exchange, intelligence and analytics
  • Improved and more efficient detection and processing of safety signals

Slide 10 - Proposed reporting formats

  • System to system transactions
  • Online forms on TGA website
    • Unregistered users
    • Registered users
  • Email, fax and mail
  • Telephone

Slide 11 - System to system - E2B/HL7

  • ICH E2BM working group developed a guideline to facilitate the standardisation of the data elements for the transmission of individual case safety reports (ICSRs).
  • ICH then developed a standard (E2B R2) for the electronic transmission of ICSRs which used standard generalised markup language (SGML) and a document type definition (DTD) describing the data elements and their relationships.
  • E2B R3 is the latest standard based upon an HL7 ICSR model that is capable of supporting message exchange for a broad range of products.

Slide 12 - E2B/HL7 cont.

  • E2B R3 uses an 'ICH-subset' of the data elements within the ISO/HL7 27953- 2:2011 standard
  • The ISO/HL7 27953-2:2011 standard is based upon ISO N545 and HL7 ICSR Release 1 and 2
  • HL7 ICSR standard supports the exchange of data and other safety reporting requirements such as adverse events and product problems associated with the use of therapeutic products
  • ISO/HL7 27953-2:2011 uses HL7 V3 messaging

Slide 13 - What next?

The TGA would like to understand the current and planned capabilities of your adverse event management systems in terms of exchanging adverse event information. For example, are you exchanging adverse event information in the E2B R3 format with overseas regulators?

This information will assist us in developing reporting formats under AEMS which meet our stakeholder needs.

We would also be interested in working with you to identify other potential benefits e.g. self service capability which you believe could add the most value to your organisation.

Slide 14 - How to register

  • You can register your interest in participating in the AEMS project by emailing your details to
  • The provided details should include:
    • Your name
    • Organisation
    • Email address
    • Phone number

Thank you in advance for your time and contribution, we highly value your support during this process.

Slide 15 - Questions and answers


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