Some very significant legislative changes have recently been made to the Therapeutic Goods Act 1989 (TGA) in respect of the regulation of complementary medicines in Australia.
The changes to the TGA have come about as part of the legislative response to the Review of Medicines and Medical Devices Regulation (Review). The Review was primarily undertaken to identify the extent to which the existing regulation of therapeutic goods (including complementary medicines) was unnecessary or ineffective. The Review also sought to identify opportunities to improve Australia's regulatory framework to enhance Australia's position globally in respect of the development, manufacture, promotion and regulation of therapeutic goods (including complementary medicines).
The TGA amendments directly impact the complementary medicine industry and include:
- the publication of a list of permitted indications being all of the permitted indications allowed for listed complementary medicines;
- creation of a third pathway (referred to as “assessed listed medicines”) by which complementary medicines can be entered on the Australian Register of Therapeutic Goods (Register);
- statements of efficacy ("claimers") on product labelling and advertising in respect of "assessed listed medicines", being subject to pre-market assessment by the Therapeutic Goods Administration;
- categorisation of new ingredients as permitted ingredients for listed complementary medicines; and
- changes in the requirements to be met in respect of advertising medical devices and medicines (including complementary medicines).
Unless manufacturers and suppliers of complementary medicine comply with the new requirements within the relevant timeframes, their products may no longer be able to remain listed on the Register.
Manufacturers and suppliers of complementary medicine will need to review all of their current listings for complementary medicines to ensure that any indications claimed on products are included on the list of permitted indications. Listed products that make higher level claims (i.e. indications which fall outside of the list of permitted indications) may require re-listing by way of the "assessed listed medicines" pathway. We consider that certain complementary medicines will need to be relisted in this manner, failing which they can no longer be offered for sale legally in Australia.
Any business developing new ingredients for complementary medicine products, which are included for the first time in the list of permitted ingredients, may be granted two years "market exclusivity" for use of those ingredients in respect of its listed complementary medicines.
These changes impact all complementary medicines businesses conducting business in Australia. In coming weeks, we will be publishing a series of papers which focus on these changes to the regulation of complementary medicines in Australia and the actions required by your business.