The TGA has invited comment on the proposed accelerated pathways for medical devices and Australian conformity assessment bodies for medical devices, announced as part of further consultations on elements of the Medicines and Medical Devices Review (MMDR).
Since the release of the MMDR and the Australian Government’s release of its response, the TGA is progressing with the policy, design and implementation of the accepted recommendations. Four relevant consultations are currently underway for the medicine sand medical devices industry.
Industry is invited to comment on these proposals for implementing the MMDR review recommendations through AusBiotech and/or via the relevant consultation pages on the TGA website:
- Designation of Australian Conformity Assessment Bodies for Medical Devices – Implementation, see https://www.tga.gov.au/consultation/consultation-designation-australian-conformity-assessment-bodies-medical-devices-implementation; and
- Accelerated Assessment of Medical Devices – Priority Review Pathway – Implementation, see https://www.tga.gov.au/consultation/consultation-accelerated-assessment-medical-devices-priority-review-pathway-implementation.
Both these consultations close on 11 January 2017.
Also open at this time, closing on 12 December 2016, are the consultations on:
- The proposed expedited pathways for prescription medicines eligibility criteria and designation process, https://www.tga.gov.au/consultation/consultation-expedited-pathways-prescription-medicines; and
- The proposed criteria to identify comparable overseas regulators (CORs) for prescription medicines – which will potentially be applied to biologicals (cell and tissue therapies). The consultation details and the proposed criteria for CORs can be found at: http://www.tga.gov.au/consultation/consultation-criteria-comparable-overseas-regulators
The MMDR has prompted 16 consultations, which will be rolled out by March 2017. The full schedule can be found at: https://www.tga.gov.au/implementation-reforms-public-consultation-forecast?mc_cid=cfa82211db&mc_eid=1852e38ea6
AusBiotech members are invited to contribute to AusBiotech’s submission, by contacting Deputy CEO, Lorraine Chiroiu (lchiroiu@ausbiotech.org/ 0429 801 118) or National Programs Manager, Helen Arthur (harthur@ausbiotech.org, 0419 914 191) prior to respective TGA closing dates.