The document, "Advertising Compliance Self-Assessment Checklist: Consumer Advertising," is a comprehensive guide designed by the Therapeutic Goods Administration (TGA) to aid advertisers in ensuring their consumer advertisements comply with the Therapeutic Goods Act...
The purpose of an evidence package is to demonstrate to the TGA that the medicine will produce the therapeutic effects described by its indications, as stated by the sponsor's legal responsibilities. Evidence can come from sources showing traditional use or scientific...
Beauty devices in Australia have lived in an area of regulatory uncertainty. Some businesses have taken advantage of this and some of those have felt the wrath of the TGA. The TGA has now provided clear guidance on what they require for regulatory compliance....
(Based on an article published in the Financial Review dated 18 August 2023*.) At DTS, our call sign is "Right First Time," but this principle must always be balanced with the level of compliance necessary to satisfy regulators. No client wants to waste resources on...
DTS will transition to a Four-Day Working Week from the 4th September 2023. Our operational days will now be from Monday to Thursday, with Fridays becoming an additional day off. “At DTS, following our flexible work practices, our aim was to further evolve and offer...
If you wish to use a chemical in Australia, then it must be listed with AICIS. If it is not, then it needs to be categorised. The AICIS categories are based on health/environmental risks and the importation volumes of the individual chemical and are listed below. The...
The Therapeutic Goods Administration (TGA) is responsible for evaluating new substances for use in Listed therapeutic products in Australia. The evaluation process typically involves the following steps: Pre-submission phase -The first phase includes applying for new...
IUCLID for AICIS submissions allows for a more efficient and streamlined preparation process.
Earlier this year the APVMA released new risk assessment Module Descriptors required for new applications for Agriculture and Veterinary chemicals for applications received after 1 February 2023. The new document can now be reviewed to understand better how the...
The Therapeutic Products Bill was introduced to New Zealand Parliament on 30 November 2022. It is intended to replace the current Medicines Act 1981 & Dietary Supplements Regulations 1985. The aim of the Bill is to regulate medicines, medical devices and natural...
Australian sponsors of listed or registered medicines must meet their pharmacovigilance reporting responsibilities for all the medicines you have registered or listed on the Australian Register of Therapeutic Goods (ARTG). As a sponsor of medicines approved for supply...
Suppliers, Manufacturers, and Importers of workplace hazardous chemicals From 1 January 2023, all hazardous chemicals will need to adhere to GHS 7. Australia has decided to transition from GHS 3 to GHS 7 after key international trading partners have decided to make...
Software is increasingly being used both as a medical device and in medical devices. Some of these devices inform clinical decisions. Others are wearable and provide day-to-day health or wellness-related monitoring and reporting functions. The demand for such devices...
Recently importers have experienced longer than usual timeframes in the processing of import permit applications. This is due to an increasing volume of permit applications being received. Whilst the Biosecurity Act 2015 provides up to 123 days to assess permit...
From 1 July 2022, advertisements must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Online/social media advertising This requirement to comply with the 2021 Code applies retrospectively to advertisements including social...
The Therapeutic Goods Administration (TGA) has provides an updated draft ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘Evidence guidelines – Guidelines on the...
The TGA have published a new Advertising Code (2021) from commencement on 1 January 2022 with a 6 month transition period ending on 30 June 2022. Below is an overview provided by Complimentary Medicines Australia. Overall changes Definitions are made easier to access...
There's less than a year to go before the transitional arrangements end. You can keep introducing chemicals under the following NICNAS exemptions until 31 August 2022: research and development – less than 100 kg cosmetic use (no unreasonable risk) – less than 100 kg...
TGA has released a new guidance document on borderline disinfectants and related products. This has provided clearer guidance on Excluded goods that are exempt from regulation under the therapeutic goods framework. While these products may be required to meet relevant...
Due to the COVID-19 pandemic, there has been significant interest from potential sponsors and manufacturers in producing and selling disinfectants and other related products to the Australian market. There is specific interest on whether claims made to remove, kill,...