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Submissions received: Strengthening monitoring of medicines in Australia

1 September 2017

The TGA would like to thank respondents who provided submissions in response to the March 2017 public consultation paper, Consultation: Strengthening monitoring of medicines in Australia.

A total of 46 public submissions were received from the pharmaceutical industry and their representative organisations, health professionals and their representative organisations, consumer groups and individuals.

The submissions that gave permission to be published on the TGA website are now available below in PDF format. However, submissions that contained sensitive personal information and/or did not address the initiatives being consulted on have not been published, even where the respondent gave their permission to do so.

A separate public consultation paper sought comments on the implementation of a Provisional Approval pathway for prescription medicines. Submissions received in response to this consultation process can be found here.



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TGA response

Feedback has been considered from the 46 submissions received and from additional targeted consultation held with pharmaceutical industry and their representative organisations, health professionals and their representative organisations and consumer groups. The majority of respondents provided broad support for the proposals on which they commented, noting that not all proposals were relevant to all respondents. Changes as a result of this public consultation process are summarised in the Outcome Summary below.

Given the level of support expressed for the proposals TGA is now working with key industry, health professional and consumer groups to implement the proposals and communicate the changes and educate impacted stakeholders. This includes further information on process details for the initiatives consulted on being included in guidance documentation to be released on the TGA website as they become available.

Outcome Summary

Change Table 1: Summary of changes resulting from public consultation: Strengthening monitoring of medicines in Australia
Current situation Proposed changes Benefits
Pharmacovigilance Inspection Program (PVIP)

Sponsors are required to submit information to the TGA regarding pharmacovigilance activities.

The TGA currently has no formal process in place verifying that sponsors maintain appropriate records or report adverse events as required.

Legislative changes have been made to allow the TGA access to sponsors’ premises to inspect their pharmacovigilance records.

The PVIP will ensure sponsors are meeting their pharmacovigilance record keeping and reporting requirements.

The program will provide greater assurance to the Australian public that medicine safety reporting is closely monitored.

Risk Management Plan (RMP) Compliance Monitoring

Sponsors are responsible for undertaking the activities set out in the RMP. They may be required to undertake additional pharmacovigilance or risk minimisation activities. Reports regarding these activities are intended to be provided to the TGA for monitoring purposes. However, the TGA has no proactive mechanism for monitoring the compliance of sponsors with their RMP requirements.

The TGA will implement a system of compliance monitoring for medicines with an RMP, including all provisionally registered medicines.

This will include a database to track RMP requirements. Sponsors will be contacted if high priority activities appear to have not been completed within agreed timeframes.

The TGA will be able to proactively monitor sponsors compliance with their RMP. This will enable early identification and remediation of non compliance.

Black Triangle Scheme

There is no current mechanism to alert health professionals and consumers that a medicine is newly registered, or has had a significant change in the indications for which it is approved.

The TGA will require certain newly registered and provisionally registered medicines, and some with new indications, to display a black triangle symbol on the relevant medicines information.

The symbol is intended to prompt health professionals and consumers to report any adverse effects. The symbol will remain on the medicine for a period of five years.

The symbol will highlight that the medicine is newly registered, or is now indicated for use in a significantly different population or for a significantly different condition.

Text accompanying the symbol will advise health professionals and consumers to report any adverse events (side effects) associated with the use of the product.

Product Information (PI) Reformat The current PI format is unique to Australia and does not present the critical clinical information in a readily accessible format.

The PI will be reformatted to:

  • Bring the clinical information (e.g. indications, contraindications, precautions for use and dosage and administration instructions) to the front of the PI
  • Align closely with the format of the New Zealand Data Sheet and European Summary of Product Characteristics.

Bringing the clinical information to the front of the PI will improve the usability of the document and increase its usefulness as a risk minimisation tool.

Aligning the format with international regulators reduces the regulatory burden.

Adverse Events Management System (AEMS) The current system for receiving adverse events (Adverse Drug Reporting System [ADRS]) is not compatible with international systems.

Implementation of a new IT system to streamline the way sponsors, health professionals, state and territory health departments and consumers submit adverse event reports electronically to TGA.

For sponsors, the same electronic reporting standards as those used for reporting adverse events to overseas regulators will be used.

The new system will make it easier for:

  • sponsors to meet their mandatory reporting requirements following alignment of the data standards
  • TGA to share more complete adverse event data with World Health Organisation (WHO) and thereby facilitate international regulatory collaboration and make a stronger contribution to international pharmacovigilance endeavours.