Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

NICNAS Public Consultation Forecast

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the use of all chemicals within Australia, as well as helps protect the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use. All current and planned public consultations on the implementation of NICNAS reforms (listed as reforms), as well as existing risk assessment and regulatory processes (listed as non-reforms), can be found here: NICNAS consultation timelines

Accord Australasia Dispels Personal Care Myths

Accord Australasia is the peak national industry association representing manufacturers and marketers of hygiene, cosmetic and specialty products, their raw materials suppliers and service providers. In seeking to clarify misconceptions regarding cosmetics, personal care & household products, they have set up a website www.Furphies.org.au and ask such questions as: Is there lead in lipstick? Do sunscreens pose a health risk? And what does 'chemical free' or 'natural' really mean? Find the answers to these questions and much more at: Furphies

Quote for the month:

“As a start-up CEO I slept like a baby. I woke up every two hours and cried”   Ben Harowitz (Co-founder, Opsware)

 

RFA Looks Forward to Naturally Good Trade Expo 2018 in Sydney

Far more than just a tradeshow, Naturally Good Expo is a total business event (‘trade-only’) that’s 100% devoted to all things healthy, organic and natural. As the largest event for healthy retailers, brands and practitioners in the Southern Hemisphere, it’s the place where serious buyers meet with suppliers for two days of business, networking, education and to celebrate the latest exciting opportunities within the health and wellness retail market. To be held in the Sydney Convention Centre, Darling Harbour on April 29th and 30th, RFA Regulatory Affairs will have our own booth C 43 and we hope to see you there.

 

NGE18 logo

In September 2017, the TGA released guidance on the pharmacovigilance responsibilities of sponsors.  Newly developed, this training course is for sponsors and their nominated pharmacovigilance staff with complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.  All required documents including SOPs and reporting templates will be provided for your future use. This one hour training course is available via Skype or in person in our office in Glebe, Sydney. You will receive full course notes, document templates, SOPs and a certificate of attendance.  This is all included in the price.

For more information or to schedule a training time, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it.

*****************************************************************************************************************

This Month’s Newsletter Sponsor:

IME

 

Supporting the Complementary Health Industry.

IME’s extensive experience as a leading insurance broker in the Complementary Medicine Industry, can provide you with the perfect insurance remedy for your Complementary Health Business. IME has over 20 years’ experience in assisting  businesses involved in the manufacturing and distributing of complementary medicines, vitamins, allied health products along with practitioners of most modalities. No other insurance broker in Australia is better suited to arranging these types of insurances.

Visit http://imeinsurance.com.au/complementary-health/ or call Philip Watson mobile 0423791368 for a no-obligation chat to discuss the best ways to protect your products and your business.

Makers of Nurofen Ran 'Misleading and Deceptive' Campaign Against Panadol

"Nurofen is better than paracetamol for common headaches," declared the advertisements in women's lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle. GlaxoSmithKline, the makers of Panadol​, alleged Nurofen's manufacturer, Reckitt Benckiser​, ran an advertising campaign saying Nurofen was faster and more effective than Panadol, or paracetamol, despite there being no scientific evidence to support it. The judge granted a permanent injunction, barring Reckitt Benckiser from making those or similar claims, and for the company to pay GlaxoSmithKline's legal costs.    Source: Pain for Nurofen

Editor’s note: Regular readers of our newsletter will remember that we reported in April 2017 that the makers of Nurofen, Reckitt Benckiser, were ordered to pay $6 million penalty for false and deceptive advertising   Nurofen penalty

ABC-AHP-NCNPR Announces Botanical Adulterants Program Name Change

The American Botanical Council (ABC) announces a change in the name of the Botanical Adulterants Program, updated to the Botanical Adulterants Prevention Program. ABC and its partners at the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi decided to add “Prevention” to the name in order to emphasize the purpose and intent of the program. “The program’s goal has always focused on prevention,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “What we’ve been trying to do is alert industry members about specific botanical materials that we have confirmed as being adulterated, and counsel industry on the optimum laboratory analytical methods to help determine authenticity of botanical ingredients. By adding the word ‘Prevention’ to the name, we are making our intention clearer to all stakeholders.”    Source: ABC prevention

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Publishes Ginkgo Leaf Extract Adulteration Bulletin

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. Ginkgo is one of the most important medicinal plants worldwide. Ginkgo leaf extract dietary supplements have been consistently among the 25 top-selling herbal supplements in the United States for more than a decade. Reports on ginkgo extract adulteration date back to 2003, when researchers observed uncharacteristically high amounts of the flavonoid rutin in a sample of bulk material. The addition of flavonoids from extraneous sources, which attempts to bring these “ginkgo” extracts in compliance with the 24% flavonol glycoside content standardization required by various pharmacopeial standards, has been confirmed in numerous subsequent papers.    Source: Adulterated ginkgo

TGA Announces Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. From this date, sponsors must follow the provisions of the new URPTG and the former (2004) version will be archived.    Source: Recall protocol

TGA 2017 List of Complementary Medicines Cancelled from the ARTG

Following a review by the Therapeutic Goods Administration, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. There were 10 cancellations of complementary medicines in 2017. They are listed here along with the reason for cancellation: CM cancellations

TGA Warns Against Human Placenta Ingestion

The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. They are advising expectant mothers to be aware of the potential risks associated with placenta consumption. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if the placenta is ingested by another person or you ingest another person's placenta. Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production. Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.    Source: Placenta ingestion

Business Process Improvements Supporting Complementary Medicines Assessment Pathways for TGA

The TGA acknowledged all respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways. A total of 14 submissions were received. All submissions that gave permission are published here: Submissions & feedback

TGA Safety Advisories –    Source: 2018 alerts

Yunnan Feng Shi Ling capsules: the capsules contain the undeclared substance paracetamol (also known as acetaminophen).

Sydney New Year fireworks

Makers of Nurofen Ran 'Misleading and Deceptive' Campaign Against Panadol

"Nurofen is better than paracetamol for common headaches," declared the advertisements in women's lifestyle magazines. The Federal Court has found that claim to be misleading and deceptive, after two pharmaceutical giants went head-to-head in a two-year legal battle. GlaxoSmithKline, the makers of Panadol​, alleged Nurofen's manufacturer, Reckitt Benckiser​, ran an advertising campaign saying Nurofen was faster and more effective than Panadol, or paracetamol, despite there being no scientific evidence to support it. The judge granted a permanent injunction, barring Reckitt Benckiser from making those or similar claims, and for the company to pay GlaxoSmithKline's legal costs.    Source: Pain for Nurofen

Editor’s note: Regular readers of our newsletter will remember that we reported in April 2017 that the makers of Nurofen, Reckitt Benckiser, were ordered to pay $6 million penalty for false and deceptive advertising   Nurofen penalty

ABC-AHP-NCNPR Announces Botanical Adulterants Program Name Change

The American Botanical Council (ABC) announces a change in the name of the Botanical Adulterants Program, updated to the Botanical Adulterants Prevention Program. ABC and its partners at the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi decided to add “Prevention” to the name in order to emphasize the purpose and intent of the program. “The program’s goal has always focused on prevention,” said Mark Blumenthal, founder and executive director of ABC and founder and director of BAPP. “What we’ve been trying to do is alert industry members about specific botanical materials that we have confirmed as being adulterated, and counsel industry on the optimum laboratory analytical methods to help determine authenticity of botanical ingredients. By adding the word ‘Prevention’ to the name, we are making our intention clearer to all stakeholders.”    Source: ABC prevention

ABC-AHP-NCNPR Botanical Adulterants Prevention Program Publishes Ginkgo Leaf Extract Adulteration Bulletin

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. Ginkgo is one of the most important medicinal plants worldwide. Ginkgo leaf extract dietary supplements have been consistently among the 25 top-selling herbal supplements in the United States for more than a decade. Reports on ginkgo extract adulteration date back to 2003, when researchers observed uncharacteristically high amounts of the flavonoid rutin in a sample of bulk material. The addition of flavonoids from extraneous sources, which attempts to bring these “ginkgo” extracts in compliance with the 24% flavonol glycoside content standardization required by various pharmacopeial standards, has been confirmed in numerous subsequent papers.    Source: Adulterated ginkgo

TGA Announces Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)

Sponsors of therapeutic goods needing to initiate a product recall are reminded that the new URPTG takes effect on Monday, 15 January 2018. From this date, sponsors must follow the provisions of the new URPTG and the former (2004) version will be archived.    Source: Recall protocol

TGA 2017 List of Complementary Medicines Cancelled from the ARTG

Following a review by the Therapeutic Goods Administration, complementary medicines can be cancelled from the Australian Register of Therapeutic Goods. There were 10 cancellations of complementary medicines in 2017. They are listed here along with the reason for cancellation: CM cancellations

TGA Warns Against Human Placenta Ingestion

The TGA is aware of several websites offering expectant mothers services for the preparation of the placenta for consumption; a practice known as placentophagy. They are advising expectant mothers to be aware of the potential risks associated with placenta consumption. Human placenta is a biological material and is capable of containing and transmitting infectious agents, including bacteria and viruses. In addition, preparation may inadvertently introduce infectious agents. The risk of transmission may be even greater if the placenta is ingested by another person or you ingest another person's placenta. Prepared placenta products, including in capsule or tablet form, are often associated with claims that consumption will have some therapeutic benefit for mothers and/or children, for example, improving mood, energy levels and milk production. Under the Therapeutic Goods Act 1989, it is an offence to make therapeutic biological products without holding the appropriate licence. Depending on the circumstances and the claims made in relation to the product, these laws could also apply to the midwife, doula or even the mother involved.    Source: Placenta ingestion

Business Process Improvements Supporting Complementary Medicines Assessment Pathways for TGA

The TGA acknowledged all respondents who provided submissions in response to the September 2017 public consultation paper Consultation: Business process improvements supporting complementary medicines assessment pathways. A total of 14 submissions were received. All submissions that gave permission are published here: Submissions & feedback

TGA Safety Advisories –    Source: 2018 alerts

Yunnan Feng Shi Ling capsules: the capsules contain the undeclared substance paracetamol (also known as acetaminophen).

Subcategories

Go to top