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Implementing regulatory reforms: minimising the business burden

25 Feb 2020 2:09 PM | Anonymous member (Administrator)

In Australia, the regulation of complementary medicines falls within the remit of the Therapeutic Goods Administration (TGA), which has the responsibility of regulating all therapeutic goods, including medicines and medical devices. The TGA is committed to contributing to Australia’s health system through best practice regulation of health products, and safeguarding the health of all Australians through effective, timely and risk proportionate regulation of therapeutic goods.  


The Australian complementary medicines industry, with high-quality products supported by one of the most rigorous regulatory frameworks in the world

Medicines and Medical Devices Regulation

CMA acknowledges the significant work that has been undertaken to date by the TGA on the Medicines and Medical Devices Regulation (MMDR) reforms. 


The main objectives of the MMDR were to improve the timely and safe access to quality therapeutic goods for consumers while ensuring that any legislative framework is commensurate with the risk of such goods, and to minimise the regulatory and administrative burden for business;  This is consistent with the need for Australia to remain competitive on the global stage. 


Decreasing regulatory and administrative burden

Central to the MMDR was the decrease in regulatory and administrative burden for businesses. While industry recognises that reforms create additional work for both the regulator and for companies, an unnecessary burden is currently being created due to staggered time frames for implementation of the numerous rule changes. This is creating a level of complexity and financial burden for industry, the significance of which, particularly for smaller and medium-sized entities, cannot be overstated. 


Additional regulator resources to upgrade eBusiness Services

Unless specifically exempt, complementary medicines supplied in Australia are required to be entered onto the Australian Register of Therapeutic Goods (ARTG) maintained by the TGA. Unless they are included on the ARTG, complementary medicines cannot legally be imported, exported, manufactured, or supplied to consumers. Because the vast majority of complementary medicines are in the lower risk AUST L category, sponsors access the eBusiness portal to include, update or amend product listings. 


Under the MMDR, the TGA has established a list of ‘permitted indications’ from which sponsors must exclusively draw when listing an AUST L product on the ARTG. This, among other changes to eBusiness, has led to an increasingly overwhelmed, prolonged and creaking system. Anyone who has spent 40 minutes on hold on their telephone can appreciate the frustration and loss of productivity for a business that has to update many listings routinely. 


The TGA is experiencing issues with the TGA Business Services portal The TGA is currently experiencing issues within the TGA Business Services (TBS) portal. We are working on resolving the issues as quickly as possible and apologise for any inconvenience.


The best of natural health

In a supportive business environment, the Australian complementary medicines industry is expected to continue its positive growth trajectory, increasing innovation-rich manufacturing and providing a significant contribution to our country’s exports.


Robust evidence in several areas shows that complementary medicines are a valuable and cost-effective way to improve health outcomes. An ageing population and increasing rates of chronic disease foreshadow higher healthcare costs in the future unless there is a focus shift towards early prevention, encouraging healthy and active ageing, and supporting individuals to take control over their health.


To fully realise the contribution that complementary medicines can make to the health of our communities, research is essential for continuing to establish their safety and efficacy, to contribute to understanding best practice for integrative health care, and to develop innovative new products.  The Australian complementary medicines industry, with high-quality products supported by one of the most rigorous regulatory frameworks in the world and exceptional research organisations, has much to offer – quite simply, the best of natural health. 



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