Australia gears up to reform drug, device regulations, speed access to therapies

PERTH, Australia – The pharma and medical device industry praised the Australian government on new reforms announced late last week that increase the pathways for marketing approval for drugs and devices and reduce regulatory red tape and redundancies.

The Ministry of Health said the reforms would be rolled out by the Therapeutic Goods Administration (TGA) over the next two years.

Overall, the reforms stress a systems-based approach that focuses on long-term sustainable goals to both increase access to therapies and remove unnecessary regulatory burdens for industry. Among the reforms are new pathways that allow for earlier access to medicines by relying more on overseas regulators to assess medicines and increase efficiency.

"Bringing medicines onto the Australian market quicker will be achieved, in part, by greater use of medicines by comparable overseas regulators like the U.S. FDA and the European Medicines Agency," said Health Minister Susan Ley. She said the moves would bring Australia in line with other international regulators.

Under the current regulatory structure, Australian patients have to wait up to 15 months longer than the U.S. and Europe to access breakthrough medicines.

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The government signed off on the majority of the 58 recommendations made by an independent review panel that was commissioned in October 2014 to examine Australia's drug and device regulatory framework. It was tasked with identifying areas that were duplicative or ineffective, and to look for opportunities to position Australia to be more globally competitive.

Regulatory reforms were especially needed since plans to form a joint "Australia New Zealand Therapeutic Products Agency" fell apart almost a decade ago. When those negotiations were put on hold, the Australian government agreed to introduce reforms to the TGA.

Measures were put in place in 2010 that were supposed to streamline processes by providing more predictability but instead created more barriers, according to Medicines Australia, which represents the research-based pharmaceutical industry in Australia.

Medicines Australia spokesman James Boyce told BioWorld Today that the association was "very happy" with the outcomes of the Medicines and Medical Devices Regulation Review and the health minister's policy response.

Boyce said the major features of Medicines Australia's submission were included in the recommendations, "particularly fast-track priority reviews and use of comparable jurisdiction decisions on medicines."

The association stressed the need for multiple approval pathways, including fast-tracked, priority registrations, breakthrough medicines and re-establishing flexibility. The association said the latter point was especially important because Australia needs a regulatory system that is "fit-for-purpose" – one that is adaptive and responsive to changes in business and technology and is cost-effective for both government and industry.

The reforms will expedite approval processes for drugs already approved by other "comparable and trusted" regulatory authorities.

Postmarketing monitoring will also be enhanced, and the TGA will simplify the processes for advertising regulated products. It plans to eliminate vetting and approving advertising for drugs and devices in favor of a more self-regulating model. The government stressed the need for sponsor education and said it would instigate stiffer penalties to deter inappropriate and misleading advertising.

The review did not make recommendations in relation to the Pharmaceutical Benefits Scheme, the single-payer for medicines in the country.

Still, more time is needed to explore an additional pathway for de novo assessments via other global regulators, the government said, and it would only be viable in the long term. It also stressed that regulation of biosimilars is evolving and a multiple pathways approach is not yet realistic.

MEDICAL DEVICE REFORMS

The reforms do include multiple pathways for medical devices, such as conformity assessments for marketing approvals in overseas markets provided conformity is assessed by a comparable authority, or the device is approved by a comparable overseas regulatory authority.

The government also agreed to develop transparent criteria to designate "suitably qualified bodies" within Australia to undertake conformity assessments.

The government also "accepted in principle" the idea that transparent criteria be developed and applied to comparable overseas designating authorities for evaluating devices. It stressed the need to develop criteria with stakeholders to provide transparency and clarity on how the pathways and marketing authorization would work with other regulators.

The TGA will also strive to align its regulatory processes with the European Union wherever possible, the report said, particularly with respect to the classification of medical devices, essential requirements and adopting a risk-based approach. In addition, the TGA will establish target time frames that reflect international benchmarks.

"We fully support the decision for greater use of overseas assessment to fast track access to innovative and life-saving products, without compromising the integrity and safety of medical devices in Australia," said Medical Technology Association (MTAA) CEO Susi Tegen.

Expanded access to devices will also be available for devices under Category B, which could be subject to automatic approval in order to streamline the process for certain lower-risk devices under the Special Access and Authorized Prescriber Schemes. The TGA will develop an online system to enable better monitoring of those devices and to reduce administrative costs.

"Our members, in particular the small-to-medium size companies, complain about the avoidable red tape. This report goes a long way to streamlining the regulatory burden," Tegen added.

The association said it welcomed the decision to defer establishing registries for high-risk implantable devices. It stressed that well-designed registries are costly and careful consideration needs to be given in defining areas of high risk.

MTAA commended the government reforms overall and said it supported the strategic and systems-based approach to achieve long-term sustainable reform.

The government strongly rejected a panel recommendation that the decision-making process for listing devices and drugs be delegated to the country's chief medical officer (CMO), and that a statutory committee make recommendation to the CMO. Such a move, the government report said, would slow approval processes and lead to a significant backlog of applications and undermine the entire process.

The government allocated $20.4 million in the last federal budget to implement the reform measures to improve the regulation of therapeutic goods in Australia.

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