Australia Relaxes Oversight on Some Low Risk Drugs, Devices

Regulatory NewsRegulatory News | 21 June 2018 |  By 

The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s (TGA) oversight on a range of low risk pharmaceuticals and medical devices.

The changes to the therapeutic goods framework are based on more than 1,000 submissions to a March 2017 consultation. The consultation was released as part of the government’s response to TGA’s Review of Medicines and Medical Devices Regulation, identifying ways in which to improve patient access by reducing unnecessary costs associated with entering the Australian market.

According to the regulatory agency, the government called on TGA “to examine whether the regulatory oversight applied to a range of products that represent a very low safety risk too consumers was consistent with the principles of best practice regulation, and further whether there were any opportunities for streamlining or simplifying current regulatory requirements for these products.”

In a Thursday announcement, TGA provided a rationale for each of the three products that will become exempted from certain regulatory requirements, such as premarket assessment. These include tampons and menstrual cups, nappy rash products and hard surface disinfectants.

Under a newly proposed regulatory approach on hard surface disinfectants, those that are currently listed would no longer have to enter the Australian Register of Therapeutic Goods (ARTG) prior to market entry, while others would be moved to the listed other therapeutic goods pathway.

The new approach would also change the ways in which TGA conducts premarket reviews and approvals for these products. Only new ingredients and/or specific claims would undergo premarket review and the approval process for these ingredients “will be made more transparent and predictable and will possibly include the increased use of comparable overseas regulator reports,” TGA said.

Further, antiperspirants and ear candles will be excluded from the therapeutic goods framework under the new regulation on low risk products.

“Antiperspirants that derive their antiperspirant properties from inorganic salts of aluminum, zinc or zirconium only, are already exempt medicines,” TGA explained. “However, antiperspirants are viewed by consumers as toiletries, and regulation as medicines adds few meaningful safeguards.”

TGA added it is conducting a review of all class I medical devices in the ARTG as well as low risk registered over the counter products to determine if they should be removed or become listed.

As part of the ongoing efforts for TGA to reduce its regulatory workload, the agency also implemented specific criteria last week to aid industry in identifying comparable overseas regulators (COR) and a process for work-sharing on drug applications using COR reports.


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