What makes a comparable overseas regulator?


As the TGA implements detailed consultation on elements of the Medicines and Medical Devices Review (MMDR), comment is now sought on proposed criteria to identify comparable overseas regulators (CORs) for prescription medicines – which will potentially be applied to biologicals (cell and tissue therapies).

The Federal Government has estimated that with the use of overseas reports from CORs, the MMDR reforms have the potential to reduce medicine assessment times by up to three months.

The consultation is open now and closes 12 December 2016.

The MMDR review also recommended that the TGA better utilise opportunities to work-share with CORs to improve efficiencies in review processes, develop a more streamlined entry for applicants to enter multiple international markets and potentially enable earlier access to medicines for Australian consumers.

The TGA is specifically seeking feedback on:

  • The proposed two-step process for identifying suitable opportunities for collaboration; and
  • The individual criteria for identifying a COR (Stage 1) and considerations that are taken into account when a submission or assessment report is received (Stage 2).

The TGA says the criteria outlines key factors that need to be addressed to best realise the envisaged benefits of formal international collaboration. As these criteria are finalised, detailed guidance on how they will be applied to the work-sharing and COR-report processes will be developed.

The consultation details and the proposed criteria can be found at the TGA website.

AusBiotech members are invited to contribute to AusBiotech’s submission, by contacting Deputy CEO, Lorraine Chiroiu (lchiroiu@ausbiotech.org/ 0429 801 118) by 1 December 2016.

The MMDR has prompted 16 consultations, which commenced earlier this week and will be rolled out between now and March 2017. The full schedule can be found at the TGA website.

Also open at this time is the consultation on Expedited pathways for prescription medicines eligibility criteria and designation process.