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
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
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 how THC could be legally designated as food.
Australia trials “Health Care Homes”, a new model of primary health care
Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People with Chronic and Complex Health Conditions report. Key elements of the proposed scheme included:
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 and transparent, while incorporating international best practice and removing any unnecessary regulatory burden on the pharmaceutical industry”. The review is being carried out by Adelaide Health Technology Assessment (AHTA) in conjunction with PBAC.
Australia – nicotine and therapeutic goods
A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) 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, the Therapeutic Goods Administration (TGA), refused to consider the application, on the basis that the wrong form had been used.
TPP and biologics – a battleground in Australian elections
The Australian Labor Party has flagged the data exclusivity provisions of the Trans Pacific Partnership Agreement (TPP) as a major issue ahead of our now confirmed July date for an Australian election.
The use of medical cannabis in Australia: New Victorian synthetic cannabinoids regulations commence
The Victorian Government has introduced new regulations, prescribing various forms of synthetic cannabis as drugs of dependence for the purposes of the Drugs, Poisons and Controlled Substances Act.
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.
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