TGA更新列名药品合规报告数据库，7款药品审查后2款被取消ARTG登记

We have updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 7 listed medicines, including:

• medicines missing the required warning statements or declarations for:
  • Camellia sinensis (tea),
  • Curcuma longa (turmeric),
  • sugars, potassium, sodium, benzoates and sorbates.
• medicines reviewed to check whether they meet stability requirements
• medicines with non-permitted health claims about:
  • nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN),
  • cerebral thrombosis, bowel cancer, neurodegenerative diseases, Alzheimer's disease, Parkinson's disease, cardiovascular diseases, molluscum contagiosum and eczema,
  • prevention, treatment or management of dehydration during pregnancy.

Following these reviews, 2 medicines have been cancelled from the Australian Register of Therapeutic Goods (ARTG) and are no longer permitted to be supplied.

The remaining medicines continue to be included in the ARTG. Where issues were identified during the reviews for these medicines, the sponsor was required to correct the issues.

For more information, refer to the database and listed medicine compliance reviews.

What are listed medicines and how are they regulated?

Listed medicines have an 'AUST L' number on the label and packaging, and include products such as vitamins and minerals, traditional Chinese medicines, herbal medicines and some sunscreens.

These medicines are included in the Australian Register of Therapeutic Goods (ARTG) and can be sold without being checked by the TGA for safety, quality and effectiveness. Instead, sponsors of listed medicines certify that their medicine meets all the relevant legal requirements prior to selling them.

Listed medicines can only contain ingredients that we have assessed to be of low risk. Their indications (therapeutic uses) can only be selected from a pre-approved list. The indications of a listed medicine on its label, packaging or other advertising material must be included in the ARTG entry of the medicine and must be supported by evidence.

We regularly conduct post-market compliance reviews of selected listed medicines to check for compliance. If a medicine is found to not comply with the legal requirements, we take risk-based and proportionate regulatory actions to address the non-compliance.

We publish the outcomes of these compliance reviews on the Listed Medicine Compliance Reports database on a quarterly basis to allow timely public access to safety or efficacy information of reviewed listed medicines. This assists consumers to make informed decisions when self-selecting listed medicines and avoid purchasing a product that may not be appropriate for them.