PERTH, Australia – Drug and device companies in Australia may soon be able to bring their products to market more quickly via a new priority review designation.
Health Minister Susan Ley introduced legislation to Parliament on Dec. 1 that would speed the approval of drugs and devices by providing Australia's Therapeutic Goods Administration (TGA) with new priority review mechanisms.
TGA spokeswoman Kay McNiece told Medical Device Daily that the bill is the first tranche of legislation to support the recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation, as agreed by the government in its response to the review.
Although the review found that the TGA is well respected internationally, it identified areas for improvement to provide industry with more flexible and timely pathways to market and to increase collaboration with overseas counterparts to minimize regulatory burden. The measures would also help align Australia with other global regulators as far as timelines for new drug approvals. 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.
If passed by Parliament, the bill would support a number of changes, including new regulations for expedited pathways and/or priority review for some applications for new drugs and medical devices. "These pathways are anticipated to be in place within 12 months," McNiece said.
The new priority pathways are planned to ensure that certain drugs and devices are given priority in the evaluation process, "but that they are still subject to a full evaluation of their safety, quality and effectiveness," she added.
Expedited pathways would be available for new drugs and devices that meet an unmet need for patients with serious and life-threatening conditions.
"These time frames would be the subject of industry consultation before being implemented in regulations," Ley said in her introductory remarks to Parliament. "This change removes a barrier to bringing innovative products to market statutory time frames provide a degree of certainty and allow sponsors to plan for the rollout of a new listed product containing the new ingredient."
The TGA is in the process of consulting with stakeholders on the proposed criteria for drugs and devices to use these pathways, and the proposed process for determining eligibility, she said.
INDUSTRY PRAISES PROCESS
Medicines Australia, the association that represents multinational pharma companies operating in Australia, praised Health Minister Susan Ley and the TGA "for their open and extensive consultation process."
The association said the proposed legislation would enable faster access to new medicines and would help to cut unnecessary red tape for industry.
"For a number of years, Medicines Australia and member companies have worked with the Australian Government to identify improvements in our registration approval processes," Medicines Australia Chief Executive Milton Catelin said, adding, "The bill addresses these concerns head-on."
He noted that the measures have "widespread cross-political support," and he anticipates them to be passed "without delay in 2017." NOTIFICATION MECHANISM FOR DEVICES
The proposed legislation would also allow easier access to certain unapproved medical devices via a notification mechanism rather than requiring TGA pre-approval, Ley told Parliament.
The expedited review process for devices would apply to novel devices that represent breakthrough technologies.
In addition, the proposed regulations would allow Australian device companies to undertake conformity assessments in Australia, rather than having to rely on the TGA or overseas-based assessment bodies to conduct such assessments.
The TGA would designate private bodies to conduct conformity assessments in Australia to appraise the suitability of the manufacturing process, and to assess whether devices meet minimum standards of safety and performance.
The regulations would also set criteria for qualifying to become an assessment body, how to apply to become such a body and conditions that may apply. Additionally, a body may be designated generally under the regulations, or it may be limited to assessing specific kinds of devices or specific kinds of conformity assessment requirements.
These new assessment bodies would provide an alternative avenue, other than the TGA, for device manufacturers to obtain a conformity assessment certificate required before their medical devices may be included in the Australian Register of Therapeutic Goods, Ley said in her comments to Parliament.
The bill contains a number of other amendments to the Act that are mostly aimed at achieving greater consistency between different types of therapeutic goods and reducing regulation.
And, because products would be on the market sooner, the bill proposes a more comprehensive post-marketing program that would include additional compliance requirements for sponsors as well as more prescriptive requirements for product recalls.
The Australian government allocated A$13.5 million in both operating and capital expenses from the Budget in 2016-2017 to improve the regulation of therapeutic goods in Australia.