Feedback is sought on the annual Therapeutics Goods Administration (TGA) fees and charges consultation, as AusBiotech considers its response on behalf of the biotech industry.
The TGA is proposing an increase of 2.6 percent, which is consistent with its long-established practice. This would also see fees and charges rounded to the nearest $10 for items less than $10,000 and to the nearest $100 for items $10,000 and above. If implemented, this would take effect from 1 July 2022.
Working through a 96 per cent cost recoverable model, the TGA reviews its fees and charges annually to ensure they’re set at the appropriate level and that cost recovery for each therapeutic industry sector is also appropriate.
This increase will also support the TGA to continue providing an increasing number of activities for the public good, which cannot be appropriately cost recovered from industry. These services include providing timely access to unapproved medicines (including medicinal cannabis, cell and tissue therapies and medical devices) to patients under the Special Access Scheme, the Authorised Prescriber Scheme and the Orphan Drug Program.
In addition, it is proposed that fees for clinical trial variations are amended.
2020 legislation amendments now allow variations to previously approved Clinical Trial Approvals (CTA) for medicines, biologicals and medical devices, however, also require that the change requests be accompanied by the fees prescribed in the regulations. Currently, no such fees are prescribed in the regulations. Based on the staff effort required for variation applications, it is proposed to implement the variation application fees with effect from 1 July 2022, subject to approved indexation for 2022-23. The proposed fees equate to 28% of a new CTA application fee.
AusBiotech is working with its AusMedtech Regulatory Affairs Advisory Group as it considers its response to this consultation.