Report 2

• introduce a new approval pathway for prescription medicines by creating a class of therapeutic good to be known as ‘provisionally registered goods;
• allow the minister to specify, by legislative instrument, permitted indications for use with listed medicines;
• establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list;
• strengthen monitoring powers in relation to biologicals;
• implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours;
• remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required;
• enable the Secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices;
• enable the Secretary to publish information in relation to Australian conformity assessment bodies;
• align the Secretary’s powers relating to conformity assessment certificates issued by Australian conformity assessment bodies and conformity assessment certificates issued by the secretary; and
• clarify that the Secretary has the power to refuse an application for including medicines, biologicals and medical devices in the Australian Register of Therapeutic Goods prior to evaluating the application if it does not meet the application requirements; and make minor amendments to achieve consistency of regulatory requirements between different types of therapeutic goods and make other minor changes.

Autologous platelet-rich plasma (PrP) and conditioned serum are products made from blood collected from a patient that is subsequently processed and returned to the same patient. Commercially supplied kits and equipment are available for the processing of the collected blood.

Where the products are used for a therapeutic purpose, they would be regulated under the Therapeutic Goods Act (1989) by the TGA, subject to any applicable exclusions or exemptions.

Platelet-rich plasma (PrP) is prepared from blood collected by a single uninterrupted venepuncture. The plasma is generally separated from the red blood cells by centrifugation, with the platelets present in the plasma. The next steps vary between protocols but are intended to discard both the red blood cells and the acellular plasma layers and to collect only the platelet rich plasma layer. Commercial kits are now available to assist in the preparation of PrP. Importantly, the preparation of PrP only separates and concentrates the cells without manipulating them.

Conditioned serum is also made from a blood collection, but involves use of the serum fraction which contains no platelets. In contrast to PrP, the serum is cultured to induce the white blood cells to produce anti-inflammatory compounds in to the serum, so this product is considered manipulated (see definition of minimal manipulation (link is external)).

Where PrP and conditioned serum are used for a therapeutic purpose, both would be regulated under the Therapeutic Goods Act (1989) by TGA, subject to any applicable exclusions or exemptions. A PrP product would likely be considered a blood component, being prepared only by centrifugation, filtration and freezing, and would be regulated as a medicine. A conditioned serum product would likely not meet the definition of a blood component due to the culturing of the serum to induce the white cells to release factors, and would be regulated as a biological. More information is provided below on how the different regulatory frameworks may apply to your product.

The exclusion that applies to autologous human cells and tissues, which could include PrP and conditioned serum products, is exclusively for when the blood is collected, manufactured and administered by or under the supervision of a registered medical practitioner for a patient under their care. This exclusion does not apply to other health practitioners.

Where equipment (such as a commercial kit) is used in the manufacture of PrP or conditioned serum it may also be subject to regulation as a medical device.
Cosmetic use of injected PrP or conditioned serum is likely to be regulated by TGA where therapeutic claims are made or inferred. Generally, injectable products fall under the Australian legal definition for therapeutic use (for example, as they are intended to cure a defect or modify the anatomy, even if it is only for ‘aesthetic’ purposes).

The three possible regulatory paths for these products under the Therapeutic Goods Act (1989) are detailed below:

• Excluded from regulation;
• Regulated as a blood component; and
• Regulated as a Biological.

An exclusion applies to autologous human cells and tissues which could likely include PrP and conditioned serum products, when the blood is collected, manufactured and administered by or under the supervision of a registered medical practitioner for a patient under their care. This exclusion does not apply to other health practitioners.

The exclusion that is defined in Item 4(q) of the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 applies when:

• Whole blood is collected from a patient who is under the clinical care and treatment of a medical practitioner registered under a law of a State or internal Territory; and
• PrP or a conditioned serum is manufactured by that medical practitioner, or by a person or persons under the professional supervision of that medical practitioner, for therapeutic application in the treatment of a single indication and in a single course of treatment of that patient by the same medical practitioner, or by a person or persons under the professional supervision of the same medical practitioner.

Professional supervision by the registered medical practitioner must extend to all aspects of manufacture of the product. It is expected this would involve, for instance, the registered medical practitioner taking professional responsibility for the protocols within the laboratory in relation to the manufacture of the product and also to perform, or professionally supervise, the use of the product. Ultimately, the medical practitioner would be professionally responsible for the clinical care of the patient and any outcomes of the treatment.

For further information, refer to the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 and the TGA guidance on the Excluded Goods Order.
It should also be noted that products excluded from regulation have not been evaluated for quality, safety or efficacy by the TGA, and that their manufacture and use requires registered medical practitioner oversight.

If the manufacture and supply of a PrP product does not meet the exclusion described above, the product is likely be regulated by TGA as a medicine (blood component).
For example, if collection and manufacture of a PrP product is not under the direct supervision of a registered medical practitioner, e.g. it is collected and manufactured by a podiatrist, the PrP product would be regulated as a blood component (medicine). Similarly, if a blood component is sourced from a donor different from the recipient (allogeneic), that resulting PrP would also be regulated as a blood component (medicine).

If the manufacture and supply of a conditioned serum product does not meet the exclusion described above, the product is likely be regulated by TGA as a biological.

For example, if the collection and manufacture of a conditioned serum product is not under the direct supervision of a registered medical practitioner, e.g. it is collected and manufactured by a podiatrist, the product would be regulated as a biological. Similarly, if blood was collected from a donor different from the recipient (allogeneic), the conditioned serum would also be regulated as a biological.

Designation Process

Priority designation is a formal decision by the TGA to assign priority to the assessment of an application to include a medical device in the ARTG.

Granting of priority designation does not guarantee approval for the device application itself which is still required.

To Who and What is the Designation Specific ?

The Priority Applicant designation is specific to the:

• person who is the priority applicant (as a result of either section 41ECA or 41 FKA of the Therapeutic Goods Act 1989);
• medical device (in respect of design, material, physical characteristics, and a particular manufacturer); and
• intended purpose of the device.

Specific Criteria:

• Serious condition;
• The intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; and
• Unmet need either:
  • no medical devices with that intended purpose are of a kind included in the Register; or
  • if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices) there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices;
• Breakthrough technology OR clinical advantage OR public health (in vitro device only) at least one of the following applies to the new device:
  • the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology; or
  • there is evidence that the device offers a major clinical advantage over existing alternatives included in the Register; or
  • the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.