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
medical device. D. Take into account any other information that the committees consider may be material in their deliberations. Recommendation Thirty: The Panel recommends that the Advisory Committee on Medicines Scheduling (ACMS) become a sub-committee of the Advisory Committee on Medicines and make recommendations to that committee about the: 1. Scheduling of medicines; and 2. Inclusion of medicinal substances in Appendix H of the Poisons Standard. The Commonwealth rejects Recommendation Thirty as the roles of medicine consideration for TGA registration and for scheduling are quite different. This recommendation was not supported by stakeholders. As part of the Smaller Government Agenda, the Commonwealth proposes to rationalise the number of TGA advisory committees from eleven to seven, of which the Advisory Committee on Medicines Scheduling will be retained as a standalone committee. This is due to its important role in advising the TGA on the scheduling of medicinal substances and ensuring that state and territory governments have strong input into scheduling decisions (as state law actually implements a scheduling decision). Recommendation Thirty-One: The Panel recommends that the Australian Government give consideration to organisational structures that will facilitate improved integration of: 1. Pre-market regulation of medicines and medical devices with health technology assessment of these products for subsidy and other purposes; and 2. Post-market monitoring of medicines and medical devices for safety, efficacy and costeffectiveness. The Commonwealth supports the intent of Recommendation Thirty-One, and notes recent organisational changes within the Department of Health to address process alignment and implement collaborative mechanisms. Recommendation Thirty-Two: The Panel recommends that the Australian Government review and enhance the NRA’s funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and The Commonwealth defers consideration of Recommendation Thirty-Two. The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 201718. A review of the regulator’s funding arrangements should not be conducted in isolation. Deferring consideration under the Portfolio Charging Review will ensure funding