Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) has announced that it is planning improvements around Good Manufacturing Practice (GMP) clearance.
As part of this, the TGA will be publishing an updated revision of the GMP clearance guidance document,
A new type of product claim is emerging in the Australian class action market; one which has been part of the US class action landscape for many years. Unlike previous product class actions where the safety of the product was
The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus.
The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large
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
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 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:
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.
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.
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.
From 1 July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year