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Device makers need just one tick of approval

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Locally-made hearing aids, joint implants and other medical devices could become available more quickly under a Federal Government move to streamline regulatory approvals.

Assistant Health Minister Fiona Nash has announced that Australian medical device manufacturers will no longer have to have their products approved by both the Therapeutic Goods Administration and its European counterparts if they are to be sold in both markets.

Under the new arrangements, to come into effect by the end of the year, any device that conforms to TGA or European standards will automatically be approved for use in the other jurisdiction.

“With these changes, Australian manufacturers can choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body,” Senator Nash said. “This will cut red tape, provide more flexibility for local device manufacturers and, in many cases, enable devices to get to market more quickly, which will benefit the public.”

But the Minister said the streamlined arrangement would not extent to devices considered to be high risk, such as those containing medicines, in vitro diagnostics, or tissues with animal, biological or microbial origins, which would still require TGA approval, regardless of established conformity in other jurisdictions.

While the change only applies to medical devices, it has encouraged calls for similar streamlined processes to be applied to medicines.

Prime Minister Tony Abbott appeared to give succour to calls for drugs approved overseas to be automatically given the go ahead in Australia when he launched an extraordinary attack on the nation’s system of medicine regulation last month.

Speaking in the context of the debate over the use of medicinal cannabis, Mr Abbott condemned the regulatory system as a “thicket of complexity, bureaucracy and corporate and institutional self-interest”, which should be by-passed if necessary.

“If a drug is needed for a valid medicinal purpose and is being administered safely, there should be no question of its legality,” the Prime Minister said. “And if a drug that is proven to be safe abroad is needed here, it should be available.”

The medicines industry has seized on Senator Nash’s announcement to urge that it be extended to include non-prescription drugs.

“There is no compelling reason why the Therapeutic Goods Administration should re-assess non-prescription medicines where they have already been assessed by comparable overseas regulators,” the Australian Self Medication Industry said.

Executive Director Dr Deon Schoombie said the Government move was a “great opportunity to re-visit those areas where the TGA is out of step with the rest of the world, such as down-scheduling of certain prescription medicines to non-prescription, advertising of non-prescription medicines, scheduling of combination products, and regulation of the lowest risk complementary medicines”.

But there is no indication that the Government is considering extending the change to encompass medicines, at least at this stage.

See also, Watchdog could be by-passed in drugs review.

Adrian Rollins