ASMI urges Federal Senators to support complementary medicine reforms
22 May 2018 –
The Australian Self Medication Industry (ASMI) today urged Federal Senators to pass into law the Therapeutic Goods (Permissible Indications) Determination No 1 of 2018—a key reform designed to assist consumers to make informed decisions about the complementary medicines they select.
Under the Therapeutic Goods (Permissible Indications) Determination No 1 of 2018, when sponsors apply to list a complementary medicine they will be required to select from an approved list of indications that has been determined by the regulator—sponsors will only be allowed to select indications that are accepted as low risk, replacing the previous approach requiring sponsors to assess the suitability of indications themselves.
Deon Schoombie, ASMI Chief Executive Officer, says: ‘The list of permitted indications implements one of the Federal Government’s reforms to the regulatory framework for complementary medicines arising from the Medicines and Medical Devices Regulation Review (MMDR).
‘It’s a tremendous step forward for consumers to help them make informed decisions.
‘Concerns have been expressed in the media about traditional medicines and evidence for the claims made about them.
The TGA has evidence requirements which create a clear distinction between scientific evidence and traditional evidence supporting claims about complementary medicines.
‘For a sponsor to claim a medicine has traditional evidence it must have a history of medicinal use of the ingredients or medicines that exceeds three generations (75 years) and it must be extensively recorded in internationally recognised sources.
‘We encourage Federal Senators to pass Therapeutic Goods (Permissible Indications) Determination No 1 of 2018 into law.
It’s a great win for consumers as they’ll be better able to differentiate between different categories of complementary medicines based on whether the product has scientific, traditional or homoeopathic evidence,’ he adds.