The Australian Senate Community Affairs Committee has recommended that parliament pass amendments to the Therapeutic Goods Act to implement reforms arising from the Sansom review.
The amendments will pave the way for some key changes including
- Some welcome streamlining in areas including special access submissions
- Clarifications around some advertising.
- A broadening of default standards to include European and US pharmacopoeia as defaults alongside the long standing recognition of the British Pharmacopoeia. This is most relevant to medicines but also impacts some devices.
- Establishment of Australian Conformity Assessment Bodies
This last one is the big change. And it will take some time to see how this works out in practice. TGA currently recognizes CE certificates in lieu of direct TGA assessment. however there are a couple of issues there:
- The continuing requirement for a desktop review for higher risk CE marked devices through Application Audits
- The need for re-harmonization as European requirements evolve with the replacement of the Directives with the new Medical Device and IVD Regulations.
Ideally, if TGA is able to accredit 3rd party assessors, then they should be able to get out of the Application Audit business altogether. Application audits can add 6 months or more to a device approval and this promises some substantial time savings if it’s done right. In practice, it’s expected that Australian Conformity Assessment Bodies would be local offices of the established European Notified Bodies. This is already the case in Canada and Japan for example. Again there’s a need to keep an eye on European developments as all Notified Bodies need to be re-designated under the new European Regulations and it’s widely accepted that there will be far fewer Notified Bodies at the end of that process – down from the current 70+ to maybe less than 20. There’s no point in having a Conformity Assessment Body established uin Australia if they can’t also offer CE marking. So TGA needs to place its bets carefully…
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