Technical Alerts

Implementation of FSANZ Standard 1.2.7 (Nutrition, Health & Related Claims).Comments can be sent to
submissions@chc.org.au by COB Wednesday, 13th November 2013.

Click here to read the Technical Alert.

Over a number of years the Therapeutic Goods Administration (TGA) and the complementary medicines
industry have recognised difficulties in appropriately quantifying the activity of enzymes used as active
ingredients in listed medicines. One difficult aspect has been in establishing an appropriate unit for the
enzyme activity of the improved ingredient ‘bromelains’ (Australian Approved Name).
As such the CHC seeks industry feedback on the attached proposal to assist in the resolution of this issue.

Please provide any comments to the CHC by COB Thursday, 24 October.

Click here to read the Alert.

Please find below a link to our technical alert calling for member input into the Advisory Council on Intellectual Property – Review of the Innovation Patent System.

Click Here to read the technical alert

The International Food Standards Section of the Department of Agriculture have been working with stakeholders to feed data into developing an Australian position to the Codex Committee on Fats and Oils. To assist the work of the electronic working group (eWG) on fish oils and to justify incorporating specific named fish oils in the proposed Draft Standard, please find attached a request for information on volumes and patterns of trade for different fish oils as well as information on their quality and composition.

Please use the table attached when submitting your data, located here. The deadline to provide data to Codex is the 30th September 2013.

Read the Technical Alert here.

As sponsors would be aware, when applying to list a new medicine on the Australian Register of
Therapeutic Goods (ARTG) via the listed medicines online portal (ELF), “Product Name” is one of
the mandatory data entry fields. The current maximum length of this field is 300 characters.

The TGA have identified that a very small number of medicines listed on the ARTG have additional
information entered into the Product Name field. This information is entered by the sponsor
when listing a medicine and may include the ingredients, dosage and formulation. There are other
data fields within ELF to appropriately record these medicine properties.

Read the Alert here.

The National Health and Medical Research Council (NHMRC) has called for comment on two draft documents, prepared with the aim of promoting awareness amongst clinicians of the importance of discussing complementary and alternative medicine (CAM) use with their patients. Submissions are welcomed to the NHMRC before Friday, 13 September at 5:00pm (AEST).

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The Complementary Healthcare Council of Australia (CHC) contests recent research from the US reported in the Journal of the National Cancer Institute linking Omega-3 and prostate cancer as inconclusive and contradictory of a large pool of pre-existing, robust evidence that demonstrates the health benefits of fish oil.

Please read the Alert here.

In late July and early August the TGA will be conducting road shows in Sydney and Brisbane to inform interested parties of progress with the TGA's Blueprint reform agenda, and introduce the updated listed medicines eBusiness Services (eBS) application portal. There is no fee associated with attending the road shows, however, registering is essential if you wish to attend.

Please click here to read the Alert.

The CHC invites you to comment on the paper - Draft TGA approach to disclosure of commercially confidential information (CCI). 

Submissions are welcome to the CHC  by COB Friday, 16 August for submission to the TGA by the 29 August 2013.

Click here to read more.

The CHC invites you to comment on the TGA consultation for the International Harmonisation of Ingredient Names (IHINs) Project. Submissions are welcome to the CHC  by COB Wednesday, 3 July for submission to the TGA by the 10 July 2013. A CHC representative will also be attending a TGA focus group on this project in June 2013.

Please click here for the Technical Alert.