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“The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines specify the type of evidence required to support indications made for listed medicines (excluding sunscreens and disinfectants) and help sponsors understand their regulatory obligations in relation to holding that evidence.
“Once listed in the ARTG, a proportion of listed complementary medicines are reviewed for compliance with relevant regulatory requirements. Any listed complementary medicine may be selected for compliance review at any time after it is listed in the ARTG”.
Read this much anticipated TGA report at: http://tinyurl.com/lx92fpk
In order to minimise regulatory burden, the revised document will be retained as guidelines only. The revised Evidence Guidelines: guidelines on evidence required to support indications for listed complementary medicines clarify the existing evidentiary requirements and do not impose any new regulatory requirements.
The revised Evidence Guidelines have taken into consideration, and where appropriate adopted, proposals included in the submissions received during this consultation.
The amendments make a number of minor but important changes that streamline and improve the operation of the regulatory scheme for industry, consumers, health professionals and the TGA. These changes ensure greater consistency in the regulation of different types of therapeutic goods.
A summary of the 13 main sets of amendments is set out here: http://tinyurl.com/nxtryby
Zi Xiu Tang Pollen Capsule poses a serious risk to your health and should not be taken.
The Therapeutic Goods Administration (TGA) has tested Zi Xiu Tang Pollen Capsule and found that it contains the undeclared prescription substance sibutramine - despite the product label claim that it is natural and contains no medicines.
Consumers are advised that sibutramine is a prescription-only substance (which was the active ingredient in Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. It also contains the undeclared substance phenolphthalein which was previously used as an oral laxative, but is no longer available in Australia due to serious safety concerns associated with its long term use. It also contains diclofenac, a non steroidal anti-inflammatory, an active ingredient in pharmacy only and prescription only medicines used in treatment of pain and inflammation associated with arthritis. It also contains ibuprofen a non steroidal anti-inflammatory medication, traces of glibenclamide an anti diabetic drug, and indomethacin, a non steroidal anti-inflammatory medication.
This form has been prepared to assist in the process of applying for the approval of advertisements in "specified media" to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies.
Section 3 of the Therapeutic Goods Advertising Code provides that applications for approval of therapeutic goods appearing in "specified media" must be approved by the appropriate Advertising Services Manager for compliance with the Code.
Forms are available in PDF and MS Word formats here: http://tinyurl.com/lbx4mfj
From 9th April 2014, over-the-counter medicines applications will be submitted through an upgrade to the OTC medicines online application system. Applications will be easier to submit and process and industry will benefit from this reduction in regulatory burden. Access to the upgraded system will continue to be through the eBusiness Services website. This upgrade is part of the staged implementation of the harmonisation of OTC medicines business processes in Australia and New Zealand.
Read about the benefits here: http://tinyurl.com/mwsqzka
The aim of this Bill is to establish “a system for the regulation of low-risk natural health products in New Zealand”. The Bill defines the “natural health product” as, unless the context otherwise requires, a product that is intended by the “sponsor” (i.e. a person who is resident in New Zealand and who imports or manufactures a natural health product or who arranges that importation or manufacture).
Read more at the CARSL Consulting website: http://www.carsl.co.nz/Latest+News.html
“Recent modifications to plant-based gels have made vegetarian capsules a viable option with attractive manufacturing benefits and label claims”.
Download the free digital story here: http://tinyurl.com/lzc7s6w
Health Claims for Sports Foods & Electrolyte Drinks: to permit sports foods to carry health claims about physical performance and sport-related beneficial physiological effects and to enable electrolyte drinks to make self-substantiated health claims beyond current limited permissions.
Join this consultation process here: P1030 – Health Claims for Sports Foods & Electrolyte Drinks
In 2009, Australian and New Zealand food regulation ministers agreed to a comprehensive independent review of food labelling law and policy. In December 2011, the Legislative and Governance Forum on Food Regulation agreed on a response to the recommendations contained in the review. These responses can be found on the Labelling Review website.
As part of the government response FSANZ has been asked to do work over a three year period (2012-15) on a number of the recommendations. In some cases, this will require FSANZ to provide technical advice to ministers. In other cases, reviews of existing standards will be undertaken. The nature of the request will determine the extent of any public consultation.
Read more here: http://tinyurl.com/m3vf3pp
Details of the ingredient Calcium L-threonate (AAN), can be read here: http://tinyurl.com/merk342
On 13 September 2013, NICNAS under the New Chemicals Assessment scheme has requested that the delegate consider a proposal to include the preparations containing more than 2.5 per cent zinc lactate in Schedule 6 with strong warnings listed in Appendix F of the SUSMP and use of distinctive packaging. The basis for this recommendation is that it has moderate to high acute oral toxicity and eye irritancy. The maximum permitted concentration of the chemical in any product intended for human use (or in toothpastes) should not exceed 2.5 per cent.
The delegate's reason for referring this scheduling proposal to the ACCS was that zinc lactate is a chemical referred by NICNAS following evaluation as a new chemical. Its proposed use is as an ingredient in toothpastes. The NICNAS recommendation is that inclusion in Schedule 6 is warranted on the basis of its acute toxicity profile, particularly its irritancy potential, but notes that use in toothpastes at up to 2.5 per cent should not produce adverse health effects. The NICNAS notes that this conclusion also applies to chronic exposure to absorbed zinc from the use of toothpastes. ACCS advice is needed on how to use scheduling to limit the use and concentration of this chemical in toothpastes.
Consultation on this ingredient and several others can be read here: http://tinyurl.com/laumwgp
The TGA has signed an agreement to use the docuBridge software solution to receive, review and process electronic applications for the entry of prescription medicines and other therapeutic products on to the Australian Register of Therapeutic Goods (ARTG).
The regulated industry currently incurs substantial costs when they submit large volumes of paper documentation to support their applications. docuBridge will be supplied by Lorenz, a company with global experience in working with therapeutic goods regulators and pharmaceutical companies to facilitate the transition to electronic submissions.
African Superman tablets pose a serious risk to your health and should not be taken.
The Therapeutic Goods Administration (TGA) has tested African Superman tablets and found that they contain the undeclared prescription substance sildenafil. Consumers are advised that is a prescription-only substance (which is the active ingredient in Viagra). It also contained traces of the undeclared prescription substances tadalafil and glibenclamide.
Consumers are advised that tadalafil is a prescription-only medicine (which is the active ingredient in Cialis) and glibenclamide is a prescription only substance used for blood glucose control.
The supply of African Superman tablets is illegal.
Similar warnings have been issued for the following products which are all illegal to supply:
Blue Fantasy capsules http://tinyurl.com/korvmo8
Tiger King tablets http://tinyurl.com/muafl5l
MME Naturally Maxman capsules http://tinyurl.com/macdpvb
HerbDay CoalitionHerbDay coalitionThe Ninth Annual International HerbDay will be held Saturday, May 3, to honour the many ways herbs enhance lives.
Everyone is invited to participate in HerbDay 2014. Show your support by hosting, sponsoring, and/or attending an event. HerbDay events vary widely and include lectures, workshops, herb walks, cooking demonstrations, in-store events, presentations by herbal product companies, herbal-themed children's activities, and much more. Past events have been held at retail stores, schools, farms, botanical gardens, garden centres, and public parks worldwide. If herbs are important in your life, please consider planning a HerbDay event on May 3 or during the weeks preceding and following HerbDay.
Once you've planned an event, promote it by submitting it to the HerbDay website, www.herbday.org . For more information about HerbDay activities, resources, and sponsorship opportunities; to find teachers and experts; and/or to register and promote events, visit www.herbday.org Follow HerbDay2014 on Twitter and "like" HerbDay on Facebook to share your ideas and keep current on the latest news and announcements.
(HerbDay was launched in 2006 by the HerbDay Coalition to raise awareness about the significance of herbs and the many ways they can be used to enhance health, beauty, and cooking. The HerbDay Coalition includes the American Botanical Council (ABC), American Herbalists Guild (AHG), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), and United Plant Savers. )
The Therapeutic Goods Administration (TGA) has tested these capsules and found that they both contain the undeclared prescription substance sibutramine - despite the product label claim that it is either 'All natural', or '100% herbal extracts', and contains no medicines.
Consumers are advised that sibutramine is a prescription-only substance (which was the active ingredient in the medicine Reductil). It was withdrawn in October 2010 after a study showed an increased risk of major cardiac events. The levels of sibutramine found in the Collagen Slim capsules are above the previously allowable prescription levels.
Similar warnings have been issued for the following products which are all illegal to supply:
Sanovera Starter capsules http://tinyurl.com/lsvc2ge
3X Slimming Power capsule http://tinyurl.com/kxmqogg
The Commissioner has released guidelines to help business navigate the biggest change to privacy law in 25 years. The APP guidelines will be a key resource for entities covered by the Privacy Act in assessing their compliance with the new laws. Australian Information Commissioner, Professor John McMillian, said the guidelines were an essential tool for the implementation of the March 12 change in law.
"March 12 will see the biggest change in privacy law in 25 years, and the APP guidelines are an essential tool for the implementation of this change," he said. "The APP guidelines not only outline minimum compliance requirements, they also provide practical examples of best practice."
"NICM will be seeking this year to strengthen and focus the national agenda for complementary medicine research. Working with the Australian Self Medication Industry and Complementary Medicines Australia, potentially with the assistance of the Research Translation Faculty of the National Health & Medical Research Council, we will be championing the sector's call for regulatory reform to encourage greater investment in CM research and strengthen evidence-based practice".
Read more from the NICM Director, Dr. Alan Bensoussan, here: http://tinyurl.com/k3gccp4
Life Sciences Queensland lists exciting fora for 2014.
Life Sciences Queensland Limited (LSQ) is an industry-led organisation, working closely with government, to provide leadership, promotion and growth opportunities for life sciences firms and organisations in Queensland, Australia. Upcoming events include:
International Society of Nutrigenetics/Nutrigenomics 8th Congress 2-3 May 2014 | Gold Coast,
Blackmores Institute Symposium 2014 Integrating Natural Medicine into Community Pharmacy - An Evidence Based Approach 25-26 July 2014 | Sydney, Australia (deferred date).
Conference notification: 13th Annual Oxford International Conference on the Science of Botanicals April 15th - 17th, 2014
Topics include: International regulatory and corporate approaches for safety assessments; Adulteration – the problem and potential solutions; Post market surveillance; Communicating safety to consumers; and, Safety, efficacy and quality of botanicals.
As RFA Regulatory Affairs is a keen supporter of maintaining the highest standards in complementary medicines, we are keen to point out that Mark Blumenthal of the American Botanical Council will be discussing the topic of "Adulteration in the Herbal Marketplace — An Update"
Conference details can be found here: http://www.oxfordicsb.org/
Finished product suppliers in USA are looking for distributors for their products. If you are a distributor and want to add to your product range then please contact us at RFA so that we can put you in touch with these suppliers.
RFA has supplied its staff with custom-made magnetic name badges. We highly recommend these inexpensive, high quality and professional name tags. Have a chat with David Reid at Upstart Pty Ltd.