The Panel is of the view that it is appropriate for the NRA to retain the capacity to remove a listed product from the ARTG, as well as being given the capacity to refuse to list a product in the ARTG, where it has the potential to undermine public health efforts. The NRA will need to develop clear and transparent criteria that would enable it to make such a determination, and to provide this information in guidance materials. Recommendation Thirty Four The Panel recommends that the redrafted Therapeutic Goods Act 1989 is amended to provide the NRA with the capacity to refuse to list in the ARTG complementary medicinal products and other listed medicinal products that have the potential to undermine Australia’s public health efforts. 9.4. Ingredients for listed complementary medicines Market approval of listed products is established on a riskbased approach appropriate to lowrisk products, comprised solely of approved ingredients and manufacture under GMP. In this context, maintaining an adequate level of regulatory control and protection for Australian consumers relies on the premarket evaluation of the safety and quality of the ingredients, and postmarket monitoring and compliance activities. There are approximately 10 new ingredients approved for use in listed medicines each year compared to between 1,500 and 2,000 new complementary medicinal products listed annually in the ARTG. The requirement for a premarket evaluation of new products would represent a far greater regulatory burden to industry than the current premarket approval of new ingredients. The Panel notes that there would be little value in a premarket evaluation of the efficacy at the ingredient level as that can alter when combined with other ingredients in a product. As such, efficacy evaluation is best undertaken at the product level. 9.4.1 Evidence requirements for new ingredients The Panel is of the view that safety and quality of new ingredients should be evaluated by the NRA. However, as new ingredients are not the same as new chemical entities, the rigour of evidence requirements do not need to be the same as for registered medicines. The current range of evidence that is accepted is limited and should be expanded. Other forms of evidence that may be acceptable include internationally recognised papers and articles about ingredients, and recognised monographs, for example, those developed by Health Canada for health products’. Some internationally recognised traditional medicine ‘natural pharmacopoeia may also be appropriate, noting that those based on a tradition of use do not always include a sufficient demonstration of safety, and additional information may be required of the sponsor.
The Panel is of the view that it is appropriate for the NRA to retain the capacity to remove a listed product from the ARTG, as well as being given the capacity to refuse to list a product in the ARTG, where it has the potential to undermine public health efforts. The NRA will need to develop clear and transparent criteria that would enable it to make such a determination, and to provide this information in guidance materials. Recommendation Thirty Four The Panel recommends that the redrafted Therapeutic Goods Act 1989 is amended to provide the NRA with the capacity to refuse to list in the ARTG complementary medicinal products and other listed medicinal products that have the potential to undermine Australia’s public health efforts. 9.4. Ingredients for listed complementary medicines Market approval of listed products is established on a riskbased approach appropriate to lowrisk products, comprised solely of approved ingredients and manufacture under GMP. In this context, maintaining an adequate level of regulatory control and protection for Australian consumers relies on the premarket evaluation of the safety and quality of the ingredients, and postmarket monitoring and compliance activities. There are approximately 10 new ingredients approved for use in listed medicines each year compared to between 1,500 and 2,000 new complementary medicinal products listed annually in the ARTG. The requirement for a premarket evaluation of new products would represent a far greater regulatory burden to industry than the current premarket approval of new ingredients. The Panel notes that there would be little value in a premarket evaluation of the efficacy at the ingredient level as that can alter when combined with other ingredients in a product. As such, efficacy evaluation is best undertaken at the product level. 9.4.1 Evidence requirements for new ingredients The Panel is of the view that safety and quality of new ingredients should be evaluated by the NRA. However, as new ingredients are not the same as new chemical entities, the rigour of evidence requirements do not need to be the same as for registered medicines. The current range of evidence that is accepted is limited and should be expanded. Other forms of evidence that may be acceptable include internationally recognised papers and articles about ingredients, and recognised monographs, for example, those developed by Health Canada for ‘natural health products’. Some internationally recognised traditional medicine pharmacopoeia may also be appropriate, noting that those based on a tradition of use do not always include a sufficient demonstration of safety, and additional information may be required of the sponsor.
Independent%20Review%20-%20Review%20of%20Medicines%20and%20Medical%20Devices%20-%20Stage%20Two%20Report_0.docx