Rohan Sridhar (AU)

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Australia – TGA consults on software as a medical device

The Therapeutic Goods Administration (TGA) has opened consultation on the use of software as a medical device (SaMD) as part of the International Medical Device Regulators Forum working group (IMDRF Working Group). The IMDRF Working Group comprises a number of clinical evaluators of medical devices and is seeking views on questions relating to the clinical … Continue reading

Australia – Gene Technology Regulator commences review into Gene Technology Regulations

The Australian Gene Technology Regulator has commenced a technical review of the Gene Technology Regulations (Regulations), which underpin the regulation of a range of gene technologies and genetically modified organisms. The review is aiming to ‘provide clarity about whether organisms developed using a range of new technologies are subject to regulation’ and to ‘ensure that … Continue reading

Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds

Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp.  The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … Continue reading

Australia: Review of pharmaceutical reimbursement rules

Background On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much.  The Minister said the review sought to ensure that the PBAC Guidelines are “consistent … Continue reading

Australia – nicotine and therapeutic goods

A recent Australian case ( has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can.  The supplier of the product was seeking to register the product as an OTC product, but our regulator, … Continue reading

Updates to low THC hemp food in Australia

  As previously noted, low tetrahydrocannabinol (THC) hemp for human consumption in Australia has been mooted as a potential basis of inexpensive food and expanded sales capability for farmers who currently grow hemp for industrial purposes. This has been particularly sought after in Tasmania where the majority of industrial hemp is currently grown.… Continue reading

Commonwealth issues new imported food controls

Australian Agriculture Minister, Barnaby Joyce, has introduced new orders designed to complete the Government’s changes to the Imported Food Control Regulations (Regulations) in respect of recognised foreign government certification. In March 2015, the Government amended the Regulations to allow the Minister to make orders requiring certain “risk foods” to be inspected and/or analysed under the … Continue reading

Australia – New twist in the battle between the Commonwealth and originator pharma

What it means: The Commonwealth’s desire to pursue damages pursuant to the usual undertaking seems firmly entrenched. Pharmaceutical patent holders need to consider this prior to commencing infringement actions. The Commonwealth seems to be guarded regarding the potential success of its two initial claims against originators. The Commonwealth of Australia’s ongoing battle with originator pharma … Continue reading