The Therapeutic Goods Administration (TGA) of Australia has published a guidance document describing the priority applicant determination criteria and process for all types of medical devices including the ones intended for in vitro diagnostics (IVDs).
The present document actually constitutes a second revision of the TGA guidelines on the matter. The guidance is intended to provide medical device manufacturers and sponsors with additional recommendations and clarifications regarding the current regulatory framework in order to assist them in achieving and sustaining compliance with the applicable requirements.
The TGA also reserves the right to amend the guidelines from time to time when it is deemed necessary and encourages all the parties involved in operations with medical devices to check the applicable regulations and any amendments thereto. The authority also accepts comments and suggestions regarding the guidelines and recommendations outlined therein.
Types of Priority Applicant Determinations
The provisions and rules addressed in the present TGA guidelines are prescribing the way the interested party may apply for priority determination. In particular, the guidance describes the “priority applicant determinations”.
According to the applicable regulations, priority applicant determinations provide for a person to be a priority applicant in relation to either:
- An application for a conformity assessment certificate issued by the TGA, or
- An application for inclusion in the Australian Register of Therapeutic Goods (ARTG – the country’s national register of healthcare products any medical device should be included in).
In case of priority applicant determination, the application for conformity assessment or inclusion in the national register associated thereto would be subject to review under priority consideration, consequently, the application would be prioritized by the regulating authority.
However, the TGA additionally emphasizes that the priority application determination itself does guarantee that the medical device in question would be approved or included in the ARTG – it should still comply with any and all applicable requirements. When considering the possibility to grant a priority applicant determination, the TGA does not assess compliance with the Essential Principles – such an assessment is to be completed in the later stages.
Another important aspect relates to the application timelines: in case if the interested party would fail to submit an application to the regulating authority within 6 months from the date the priority application determination was granted, the special status would be no longer valid.
In order to benefit from priority applicant determination, an interested party shall apply for either:
- Conformity assessment (priority applicant) determination, or
- Medical devices (priority applicant) determination.
The first pathway should be used in case if the applicant is interested in a conformity assessment certificate to be issued by the TGA. Such a certificate simplifies the process of inclusion of the medical device in the national register. In particular, a TGA-issued conformity certificate itself constitutes a sufficient basis for inclusion in the ARTG, hence, the interested party shall just apply for inclusion in the register and pay the appropriate application fee.
The second pathway, a medical devices (priority applicant) determination should be used in case if a conformity assessment certificate issued by the TGA is not required, while the applicant is interested in priority consideration in the inclusion process. The TGA also refers to the concept of “front-of-queue” priority consideration.
Regulatory Framework
The TGA guidelines on priority applicant determination also describe the applicable regulations governing all aspects associated thereto. According to the document, current legislation related to the matter consists of:
- Therapeutic Goods Act 1989 (the Act) in general and its Chapter 4 in particular, and
- Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
The authority also mentions that the regulations related to both types of priority applicant determinations include separate but equivalent, provisions. According to the present TGA guidance, the Act describes the aspects related to the publication of the priority applicant determinations granted by the authority on the appropriate website, while the scope of the Regulations covers:
- Application requirements,
- Criteria,
- Notification of the decision on the application for a priority applicant determination,
- Specific information to be set out in the priority applicant determination,
- Period when a priority applicant determination is in force,
- Revocation of priority applicant determinations.
The Regulations provide the definitions of the most important terms and concepts used in the context of priority applicant determinations and medical devices in general (e.g. the “intended purpose”, defined as the purpose for which the medical device is intended to be used as indicated by its manufacturer). Moreover, the Regulations also describe the actions to be taken by the applicants in case of the decision to refuse in the issuance or to revoke, priority applicant determination taken by the TGA.
Criteria for Priority Applicant Determination
According to the Regulations, the interested party applying for a priority applicant determination shall duly demonstrate that the three key criteria are met. The TGA also emphasizes that in order to be eligible for a priority applicant determination, the medical device in question should meet all three criteria described below.
- Life-threatening or seriously debilitating condition – the medical device subject to review should be intended to be used for monitoring, treatment, prevention, or diagnosis of a life-threatening or seriously debilitating condition.
- Unmet need or significant improvement – this criterion would be met in case if there is no medical device already included in the ARTG, that is intended for the same purpose, or the new medical device demonstrates a significant improvement in comparison to existing medical devices already included in the ARTG.
- Major clinical advantage (in case of IVDs – major public health benefit) – in order to meet this criterion, the medical device in question shall be based on a breakthrough technology (providing that the sufficient evidence of an advantage the technology provides are in place), or shall have a major clinical advantage over similar medical devices already placed on the market (this should be also supported by the sufficient evidence), or the early availability of the IVD in question is important for public health (i.e. results in a major public health benefit).
According to the guidance, the applicant shall provide sufficient evidence covering all 3 criteria outlined hereabove. As it is stated by the TGA, the last one usually creates the most difficulties. The epidemiological and clinical evidence provided by the applicant would be subject to rigorous assessment intended to evaluate its quality and reliability. The regulating authority places an emphasis on the importance of the quality of the evidence provided by the applicant as the key aspect to be considered by the TGA in the context of a priority applicant determination.
For instance, in order to demonstrate conformity with the first criterion, the applicant shall provide the evidence related to the life-threatening nature of the disease the medical device in question is intended to address.
Summarizing the information provided here above, the TGA guidelines on priority applicant determination describes the concept in general and also provide certain recommendations to be considered by the interested party intended to place medical devices on the Australian market. The document also outlines the particular criteria used by the regulating authority when assessing the application for a priority applicant determination.
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