Consultations and submissions
TGA consultations
The MMDR prompted 16 consultations, which were held from 2016 and 2017.
In early November, the TGA sought comment sought on proposed criteria to identify comparable overseas regulators (CORs) for prescription medicines. With the use of CORs, the Federal Government estimated the medicine assessment times could be reduced by up to three months. Other consultations open during this period included:
- Expedited pathways for prescription medicines eligibility criteria and designation process
- Designation of Australian Conformity Assessment Bodies for Medical Devices – Implementation
- Accelerated Assessment of Medical Devices – Priority Review Pathway – Implementation
- Changes to the Authorised Prescriber (AP) and Special Access Schemes (SAS)
- Options for future regulation of low risk products
AusBiotech submissions
Accelerating the assessment of medical devices
Providing comment on the Accelerated assessment of medical devices – Priority Review pathway, AusBiotech expressed support for the addition of a Priority Review pathway to expedite approval of medical devices in certain circumstances. AusBiotech contended that the proposed pathway would continue to require medical devices to meet the essential principles, including clinical evidence requirement.
However, there was concern that the proposed pathway could lengthen waits times for the vast majority of industry members if the pathway was not adequately resourced. The availability and accessibility of subject matter experts, which would enable rapid assessment of applications, may be limited since these devices would be incorporating novel technologies and/or clinical applications.
Conformity assessment bodies for medical devices
Providing a submission on the Designation of Australian conformity assessment bodies for medical devices, AusBiotech also expressed support for a system that designates bodies for medical devices to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices (IVDs), for the Australian market.
However, it was unclear whether the system proposed by the TGA would translate into reduced review times or costs for patients, industry and/or government. AusBiotech recommended that the TGA undertake research to determine whether the system would be utilised by industry and viable in Australia given potential cost, capacity, skills and experience constraints. AusBiotech also encouraged the TGA to engage with European notified bodies to gauge their interest in obtaining designation to review under the Australian regulations.
Access to unapproved therapeutic goods
AusBiotech endorsed proposed changes to improve access options for unapproved therapeutic goods, which are intended to reduce time and administrative burden and greatly improve efficiencies for applicants.
AusBiotech expressed support in its submission, Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS).
In regard to the Authorised Prescriber (AP) Scheme, AusBiotech said there was merit in relying on the expertise of a human research ethics committee (HREC) or specialist medical college to approve the clinical justification of the use of the products. Also, extending the duration of AP Scheme approval for medical devices up to three years would contribute to significant time savings for both the TGA and the applicant.
With respect to the Special Access Scheme (SAS) Category B, AusBiotech requested that additional information regarding the details of the process be provided. For example, it would be valuable to know the estimated timeframe for the TGA to initiate the process. Similarly, AusBiotech questioned whether sponsors or health practitioners would have the ability to request the TGA to initiate the process for an unapproved good to be listed as notifiable under SAS Category B.
AusBiotech also supports the TGA’s intention to effectively engage with health practitioners, as their feedback is critical to the successful implementation of the changes.
TGA bill to cut red tape
AusBiotech backed regulatory reform and the reduction in the burden of ‘red tape’ and expressed support for the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2017. The Bill will enable a number of outcomes from the MMDR to be implemented, which are expected to provide industry with annual savings of around $75 million through the reduction in red tape and regulation on the pharmaceutical and medical device industries.
The Bill forms an important step in the realisation of regulatory reform for the approval of medicines and medical devices in Australia. AusBiotech’s extensive advocacy in this area will benefit the industry with less confusion and red tape, speed, education and efficiency. AusBiotech submitted comment its submission to Senate Inquiry regarding the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016.
Low risk products
AusBiotech expressed support for evidence- and science-based regulation of medicines and medical devices that is appropriate to the risk posed by the products, presented in response to the consultation on “Options for the future regulation of 'low risk' products”. AusBiotch agrees with the TGA's statement that ‘…by reforming the regulatory approach around certain products, it would allow sponsors and TGA to better focus on the areas of risk with these products as well as on other, higher-risk products with an approach’.