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Submissions received and TGA response: Nomenclature of biological medicines

23 January 2018

We thank those who responded through submissions to the July 2017 public consultation paper Nomenclature of Biological Medicines.

A total of 34 submissions were received from sponsors and healthcare professionals supplying innovator and biosimilar medicines, individuals, government agencies, academic institutions, consumers, healthcare and other professional bodies.

All submissions that gave permission to be published on the TGA website are available below in PDF format. The TGA response is also below.

Submissions

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TGA response

Submissions received in response to the consultation showed broad stakeholder support for additional mechanisms to collect information to allow investigation into adverse events for biological and biosimilar medicines. Stakeholders' feedback informed the Government's decision to maintain the existing naming convention for biological and biosimilar medicines, that is continue using the Australian biological name (without a specific identifier suffix) and strengthen our adverse event reporting. While submissions expressed differing views, our position:

  • is supported by most respondents either as a stand-alone option or as an initial approach with a future move towards adopting a barcode system similar to the European Union (EU);
  • will improve the identification of biological medicines in the reporting of adverse events;
  • aligns with EU and World Health Organization (WHO) approaches for nomenclature of Biological Medicines;
  • does not add unnecessary regulatory burden and avoids the complexity and potential confusion that would be associated with introduction of a suffix-based system with retrospective coverage;
  • does not adversely impact the Australian Government's Biosimilar Awareness Initiative and policy to encourage uptake of biosimilar medicines;
  • does not adversely impact Australian Medicines Terminology and Australia's National Digital Health Strategy including initiatives to provide access for patients and health care providers to reports on medications through My Health Record;
  • complements the Australian Government's recent extension to funding to improve national real-time prescription monitoring using the Electronic Recording and Reporting of Controlled Drugs system for reportable S8 (and selected S4) medicines; and
  • supports quality use of medicines including safe prescribing and dispensing practice.

Implementation will involve making the product's trade name, as well as the non-proprietary name, a mandatory field when reporting an adverse event to TGA in order to provide product specificity. We will also continue our efforts to strengthen education about and reporting of adverse events. No new labelling requirements and associated costs will be imposed.

Further information on implementation, including updating the guidance document Regulation of biosimilar medicines, will be made available on the TGA website in the coming months.