Thirty one unspecified herbal products have been prioritised for review by the Office of Complementary Medicines (OCM) and Complementary Medicines Evaluation Committee (CMEC).
Another 156 botanicals with some concerns about dosage or method of preparation have undergone review with 98 deemed to be of no immediate concern.
The other 58 have been marked down for either:
- removal from the Australian Register of Therapeutic Goods
- eligible for suitable for homoeopathic use only
- suitable for topical use only
- identified for further review.
While many of these herbs are used in medicines, rules governing all botanicals are being revised in Australia, where the TGA has recognised that some of them,“demand a degree of regulatory control that is not yet in place.”
The recommendations form part of a Herbal Safety Review being conducted by the OCM and CMEC, which are themselves part of a broader review of herbal regulations in Australia and New Zealand.
This was to have established the Australia New Zealand Therapeutic Products Authority (ANZTPA), but the TGA said the review was proceeding in, “an Australian-only context.”
“The main objective of the regulatory reforms is to provide better clarity and transparency in the legislation, for regulators and external stakeholders alike,” TGA noted at a recent meeting.
Mooted changes include changes in legislative definitions governing:
- active ingredients
- complementary medicines
- designated active ingredients
- traditional use
- herbal substances
- homoeopathic preparations
Positive and negative lists will also be created for listed herbal medicines.
Discussions about complementary medicine definitions highlighted the Canadian experience, where it was noted that, “some substances were not captured by the definition of a complementary medicine that should be, and conversely, other substances were captured that should not be.”