CMA calls for light regulatory touch


lots of colourful different medicines

Complementary Medicines Australia has responded to the Government’s Expert Review of Medicines and Medical Devices Regulation by calling for regulation that reflects risk, protects consumers, safeguards quality and promotes industry best practice.

Complementary Medicines Australia promotes appropriate industry regulation to ensure consumers have access to complementary medicines of the highest quality,” says Carl Gibson, CEO of CMA.

“The complementary medicines industry calls for regulation of complementary healthcare products that is appropriate and commensurate with the risk profile of these products.”

Complementary Medicines AustraliaIn is recommending a package of measures, including:

  • Retain but simplify the existing regulatory framework.
  • Strengthen the TGA Complementary Medicines Branch with sufficient resources and sector specific expertise.
  • Cut regulatory duplication and provide faster access to new listable substances with mutual recognition of overseas regulators.
  • A new registration pathway for low risk complementary medicines making higher level health claims.
  • Simplify the Australian Register of Therapeutic Goods for listed medicines.
  • Reform of manufacturing standards, retaining GMP but ensuring that adoption of revisions of the Pharmaceutical Inspection and Cooperation Scheme (PIC/S) Code of GMP occurs on an opt-in basis by the TGA.
  • Incentivise innovation in listed medicines.
  • Abolish the advertising pre-approvals system for low risk complementary medicines.
  • Scrap the cumbersome and inconsistent Complaints Resolution Panel.
  • Replace advertising pre-approvals and CRP with a revised and strengthened co-regulatory complaints model.
  • Introduce licensing of sponsors as a cost effective solution to ensure regulatory compliance and best practice.

Gibson also warned of the unintended consequences of excessive removal of regulation.

“Australian complementary medicines are manufactured and regulated to the highest standards,” he says.

“We don’t want to throw the baby out with the bathwater, but we can make the current system work better, faster and cheaper without sacrificing our growing export market.

“This is a once in a generation opportunity to shape the regulatory framework for the future. We are advocating a ‘Light Touch – Right Touch’ not a Soft Touch approach to regulatory reform.

“Our package of recommendations is commensurate with the level of risk, will safeguard consumers and promote best practice in a growing and thriving industry that makes a real difference to the preventative healthcare agenda.”

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