Regulatory Reforms

November 6, 2016

Regulatory reforms & their impact on the Australian Complementary Medicines Industry

Implementation of reforms to the medicines regulatory framework has been the focus of many recent discussions within the pharmaceutical industry.

The Expert Panel Review of Medicines and Medical Devices Regulation has highlighted the importance of the provision of safe therapeutic goods to consumers while improving access to therapeutic goods and encouraging innovation.

In response to the Review, the Department of Health, in consultation with healthcare professionals, consumers and other industry representatives, has provided their comments on each of the 58 recommendations made. Also known as the Samson Review, this response ‘presents a strategic and systems-based approach to achieve long-term sustainable reform to the regulation of therapeutic goods in Australia’. It also ‘identifies ways to remove unnecessary red tape for industry’.

With the exponential increase in consumption of complementary medicines over the last few years, consumers have been given an opportunity to take control of their own health. The current regulatory reforms therefore aim to provide consumers with evidence-based information on the safety and efficacy of the medicines they are taking, further supporting consumer health decisions.

Increased transparency between the industry and consumers will be seen with the implementation of a ‘Permitted Indications’ list and the subsequent removal of the ‘free text’ function on the listing application. Its purpose: to remove the potentially misleading and ambiguous therapeutic claims made on listed medicines.

Additionally, an increase in the number of post-market reviews will ensure continuing sponsor compliance and adherence to legislative requirements. It’s benefits will also be seen in industry with a reduction in administrative costs.

Another significant recommendation made in this Review was the introduction of new pathways in the complementary medicines regulatory framework. These pathways will allow sponsors to make claims of efficacy by providing evidence-based information for assessment by the Therapeutic Goods Administration (TGA). Sponsors will be able to use these claims on their promotional materials.

The TGA is an internationally recognised regulatory body known for its high quality assessment and evaluation of regulatory submissions and for ensuring timely access to safe and efficacious therapeutic goods. The current regulatory reforms support the alignment of the regulatory framework to risk-based approaches and indicate the push towards an internationally harmonised framework for medicines and medical devices.

Benefits of the current reform:

  • Increased transparency, predictability and safety
  • Reduced regulatory burden and encouragement of innovation

Timeline of events:

October 2014

Ministry of Health announces Expert Panel Review of Medicines and Medical Devices Regulation

Second half of 2015

Department of Health undertakes targeted consultation on recommendations made in the Review.

September 2016

Australian Government releases Samson Review

2016-2017

Department of Health to commence design phase of reform implementation

References:

1. Therapeutic Goods Administration (TGA). (2016). Reforms to the medicines regulatory framework:
questions and answers. [online] Available at: https://www.tga.gov.au/reforms-medicines-regulatory-framework-
questions-and-answers.
2. Therapeutic Goods Administration (TGA). (2016). Complementary medicine regulatory reforms. [online]
Available at: https://www.tga.gov.au/complementary-medicine-regulatory-reforms.
3. Nicm.edu.au. (2016). NICM | Reform of Regulation of Medicines and Medical Devices. [online] Available
at: http://nicm.edu.au/news/reform_of_regulation_of_medicines_and_medical_devices

Read More

Vitex to Expand Into the Aerotropolis
Read More >
Vitex CEO Dr Aniss Chami Appointed Board Director of CHP Australia
Read More >
Vitex Pharmaceuticals’ Chief Executive Officer, Dr Aniss Chami, a panel discussion with Blacktown City Council.
Vitex CEO Dr Aniss Chami Joins A Panel Discussion with Blacktown City Council
Read More >
Vitex Pharmaceuticals’ Chief Procurement Officer, Lucie Chami, discusses the impact of Coronavirus on procurement via Podcast on Chartered Institute of Procurement and Supply
Vitex CPO Lucie Chami Discusses the Impact of Coronavirus
Read More >
Vitex Pharmaceuticals’ CEO, Dr Aniss Chami shared the Vitex journey at the Advanced Manufacturing Symposium hosted by Blacktown City Council, on Thursday 24 October 2019 at Sydney Motorsport Park, Eastern Creek.
Vitex CEO Dr Aniss Chami Shares the Vitex Journey at the Advanced Manufacturing Symposium
Read More >
Vitex Pharmaceuticals’ CEO, Dr Aniss Chami delivered the keynote speech at the 16th edition of the World Forum for Foreign Direct Investment (FDI) 2019 held on Wednesday 19 June 2019 in Sydney, Australia.
Vitex CEO Dr Aniss Chami Delivers Keynote Speech at the 2019 World Forum for Foreign Direct Investment
Read More >
Vitex Pharmaceuticals’ CEO, Dr Aniss Chami joined the Western City & Aerotropolis Authority Industry Symposium that took place on Monday 16 December 2019 at Warwick Farm.
Vitex CEO Dr Aniss Chami Participates at the Western City & Aerotropolis Authority Industry Symposium
Read More >
Vitex Pharmaceuticals’ CEO, Dr Aniss Chami had the pleasure of hosting over forty foreign diplomats based in NSW. The Western Sydney Investment Attraction Office, on behalf of the Department of Foreign Affairs and Trade, organised a visit to Western Sydney to showcase investment and trade opportunities in this rapidly expanding region.
Vitex CEO Dr Aniss Chami Welcomes NSW Diplomats at Vitex Pharmaceuticals
Read More >
Vitex Pharmaceuticals’ CEO, Dr Aniss Chami delivered the keynote speech at the Inaugural International Foreign Direct Investment (FDI) Summit held on Tuesday 29 October 2019 in Huzhou, China.
Vitex CEO Dr Aniss Chami Delivers Keynote Speech at the International FDI Summit in Huzhou, China
Read More >