PERTH, Australia – After years of consultations and pressure from industry, Australia's Therapeutic Goods Administration (TGA) will finally begin regulating autologous cell and tissue products as biologicals.

Currently, the TGA regulates human cell and tissue-based products as biologics under a risk-based system; however, autologous products (cells taken from a patient for his or her own use) are excluded from the legislation entirely and are not regarded as "therapeutic goods."

"However, there is growing global concern for patient safety due to the increasing complexity of treatments offered," the TGA said, largely because medical practitioners are manipulating cells and tissues more, which increases risk to patients. Many of those manipulation processes are akin to manufacturing "while still being excluded from TGA regulation."

The regulator is also concerned that consumers are being misled about unproven treatments through direct-to-consumer advertising for autologous products.

Following numerous consultations over the last three years, the agency will now start regulating a large portion of those autologous cell and tissue products. The level of regulation will correspond with the level of risk posed to patient safety.

Companies in the regenerative medicine space have long pushed the TGA to regulate autologous cell and tissue products in Australia, and they support the agency's moves toward stronger regulation.

AusBiotech CEO Glenn Cross said the TGA was not keeping up with international regulatory standards on that front. In its comments, AusBiotech said that "there is a need for more appropriate regulation commensurate with risk of autologous cell-based interventions, to protect the Australian public from administration of unproven, costly and potentially dangerous cell therapy treatments."

The association also acknowledged that "overly strict regulation could prevent our industry from significant innovation in cell-based therapies and deny patient access to novel clinical trials."

Regeneus Ltd. CEO John Martin told BioWorld that the stem cell community saw a steady increase of autologous stem cell transfer treatments over the years and worried that newer entrants in the space were not focused on traditional research lines around stem cells and embryonic stem cells.

Guidance three years in the making

The TGA has been working on its autologous stem cell guidance for more than three years. It published final guidance in August 2016, which suggested four possible options for regulating autologous cells.

Those options correlated with different levels of regulation based on whether the autologous stem cells were minimally manipulated. Options ranged from maintaining the status quo (with little to no oversight) to small increases in regulation to full regulation as a biologic.

The majority of stakeholders asked for more regulation. Some said regulation needed to be more specific about which autologous cells and tissues should be captured (See BioWorld, Nov. 8, 2017).

The TGA opted for the more rigorous approach and said it plans to regulate autologous human cell and tissue products under its biological regulatory framework, provided they are manufactured and used outside an accredited hospital and are more than minimally manipulated or are for non-homologous use.

It will exclude from regulation those autologous and tissue products that are manufactured and used in an accredited hospital by a medical or dental practitioner for a patient in the same care of the same practitioner.

In addition, direct advertising to consumers of autologous cell and tissue products will be prohibited. In Australia direct-to-consumer advertising is prohibited for prescription drugs; however, services that do not mention specific products will still be allowed.

Regulations will be phased in

The new approach will provide graduated regulatory oversight of autologous products commensurate with their risk, and it will bring Australia in closer alignment with other international regulators such as the U.S. FDA and the EMA, the TGA said.

Patients will still be able to access autologous human cell and tissue products through clinical trials as well as the Special Access Scheme, which provides access to unapproved therapeutic goods.

The agency said that final guidance is being drafted, and it will be submitted to government for approval in 2018. It anticipates implementing the policy in early 2018.

At that time, an advertising restriction will come into effect, and transition provisions will allow providers time to align with the new requirements. Those will include obtaining a manufacturing license and/or approval of a clinical trial. The transition period will finish at the end of 2018.

The agency stressed that detailed guidance will be published in early 2018 that will help companies interpret the new requirements.

The regulatory framework for biologicals – that began in May 2011 – provided the legislative basis for regulating human tissue and cell-derived products that are supplied, in or exported from, Australia.

Earlier this year, live animal cell, tissues or organs were added to the biologicals framework.