The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure
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
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: 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.
Australian TGA on cyber security
In a timely note, the March 2016 edition of the Medical Devices Safety Update, put out by the Australian Therapeutic Goods Administration, highlights medical device cyber security as a key issue.
Interestingly, this comes shortly after the release by
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
FSANZ calls for submissions on GM soybean
Food Safety Australia New Zealand (FSANZ) has opened submissions into a request by Monsanto Australia (Monsanto) to market (but not cultivate) food based on a genetically modified soybean line, MON-87751. MON-87751 has been genetically engineered to
Australian Government begins second awareness campaign for Health Star Rating
The Australian Government has begun further awareness raising for its multi-million dollar Health Star Rating (Health Star) system. The Health Star system aims to aid in the education of Australians regarding their food choices, through a complicated 5