Regulatory Focus™ > News Articles > TGA Opens Consultation on New-to-Market Communication Proposal

TGA Opens Consultation on New-to-Market Communication Proposal

Posted 14 May 2013 | By Ansis Helmanis

Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk communication scheme.

A new-to-market risk communication scheme is intended to signal to people using therapeutic products that a particular product is new, or newly available for a particular use.  For example, in the EU, a small black triangle is placed next to the name of new medicines. Criteria could be used to determine which products should be included in the scheme.

For medicines, these criteria might include:

  • All new chemical entities
  • Previously registered active ingredients for which registration is sought in a new indication, or for a new route of administration, combination or dose form
  • Newly registered biological medicinal products
  • Newly registered vaccines

For medical devices, these criteria might include:

  • The product is a new class IIa or above home use medical device, or an implantable class IIb, class III or active implantable medical device; and
  • A TGA evaluator considers that it has a sufficiently different or uncertain benefit-risk profile to warrant inclusion in the scheme; or
  • One of the TGA's expert advisory committees has advised the TGA to include a product; or
  • The product has previously been included in the ARTG and inclusion is now sought for a new intended purpose

Criteria would also be needed to select biological and in vitro diagnostic medical devices for inclusion, if a scheme was to be implemented and covered these types of therapeutic products.


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