Recommendations and Government Response Recommendations relating to the National Regulatory Authority role Recommendations Government response Recommendation One: The Panel recommends that Australia maintain the The Commonwealth accepts Recommendations One and Two capacity to undertake assessments of therapeutic goods for safety, quality and and recognises that maintenance of capacity to Australia’s efficacy. undertake assessments of therapeutic goods and of sovereignty of decision-making is an important assurance to consumers, and The Panel recommends that the Australian Recommendation Two: underlines strong reputation as a regulator of Australia’s Government, as a sovereign entity, retain responsibility for approving the therapeutic goods. inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG). The Commonwealth also notes that the strong reputation of the Therapeutic Goods Administration (TGA) in performing assessments is critical to the success of Australian manufacturers in exporting therapeutic goods, particularly to Asian markets. Recommendations relating to the medicines regulatory framework Recommendations Government response Recommendation Three: The Panel recommends that there be three The Commonwealth accepts Recommendation Three as it pathways to seek registration of a new chemical entity and its inclusion in the provides flexibility for industry by introducing two new ARTG: pathways (Pathways Two and Three) to registration in the ARTG. Pathway One - Submission of a complete dossier for de novo assessment. This assessment may be undertaken in full by the Australian National Pathway Two will allow for a reduction in regulatory burden by Regulatory Authority (NRA) or via a work-sharing arrangement between allowing sponsors to utilise one overseas assessment report, the Australian NRA and a comparable overseas NRA. rather than two, therefore reducing duplication of regulatory assessment between Australia and overseas. Pathway Two - Submission of an un-redacted evaluation report from a comparable overseas NRA, along with a copy of the dossier submitted to Pathway Three will provide an opportunity for novel and that NRA and an Australian specific Module 1, for assessment by the medicines to be fasttracked, either through an
Recommendations and Government Response Recommendations relating to the National Regulatory Authority role Recommendations Government response Recommendation One: The Panel recommends that Australia maintain the capacity to undertake assessments of therapeutic goods for safety, quality and efficacy. Recommendation Two: The Panel recommends that the Australian Government, as a sovereign entity, retain responsibility for approving the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG). The Commonwealth accepts Recommendations One and Two and recognises that maintenance of Australia’s capacity to undertake assessments of therapeutic goods and of sovereignty of decision-making is an important assurance to consumers, and underlines Australia’s strong reputation as a regulator of therapeutic goods. The Commonwealth also notes that the strong reputation of the Therapeutic Goods Administration (TGA) in performing assessments is critical to the success of Australian manufacturers in exporting therapeutic goods, particularly to Asian markets. Recommendations relating to the medicines regulatory framework Recommendations Government response Recommendation Three: The Panel recommends that there be three pathways to seek registration of a new chemical entity and its inclusion in the ARTG: Pathway One - Submission of a complete dossier for de novo assessment. This assessment may be undertaken in full by the Australian National Regulatory Authority (NRA) or via a work-sharing arrangement between the Australian NRA and a comparable overseas NRA. Pathway Two - Submission of an un-redacted evaluation report from a comparable overseas NRA, along with a copy of the dossier submitted to that NRA and an Australian specific Module 1, for assessment by the The Commonwealth accepts Recommendation Three as it provides flexibility for industry by introducing two new pathways (Pathways Two and Three) to registration in the ARTG. Pathway Two will allow for a reduction in regulatory burden by allowing sponsors to utilise one overseas assessment report, rather than two, therefore reducing duplication of regulatory assessment between Australia and overseas. Pathway Three will provide an opportunity for novel and medicines to be fasttracked, either through an
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