Establishing a common regulatory framework: overview of harmonisation activities
The Therapeutic Goods Administration (TGA) and Medsafe have successfully completed a series of Business-2-Business projects that deliver improved access to information about therapeutic products in Australia and New Zealand, as well as enhanced cooperation between the regulators as part of their progressive harmonisation ahead of an Australia New Zealand Therapeutic Products Agency (ANZTPA).
The TGA and Medsafe have now commenced a further program of harmonisation work that will be undertaken over the next two and a half years, which includes 14 activities across 6 regulatory areas. Provided below are links to overviews of the 14 activities, including the resulting outputs.
This new phase of joint work will progressively increase aspects of regulatory alignment between TGA and Medsafe that will facilitate business planning and align aspects of regulatory practice for the transition to ANZTPA. It will involve consultation with stakeholders as these activities are progressed.
The work of each activity has been staged to manage the workload for staff (and industry), accommodate interfaces with linked activities occurring under the Australian Blueprint reforms program and, importantly, timing dependencies for relevant ANZTPA Rules and Orders development.
These harmonisation activities are governed by the Medsafe/TGA ANZTPA Implementation Steering Committee, the same committee that successfully guided the Business-2-Business projects to completion on time and to specification.
Further information on each of the 14 activities will be made available as work is progressed.
Medicines (prescription and non-prescription)
OTC medicines (integrated pre-market business processes)
Prescription medicines (orphan drugs policy)
Prescription medicines (pre-market processes)
Prescription medicines (Product & Consumer Medicine Information)
Medicines ingredients (colours)
Medicines ingredients (proprietary ingredients)
Medicines ingredients (terminology)
Medicines safety (label warning statements)
Medicines safety (paediatric doses for paracetamol & ibuprofen)
Therapeutic products common recall code
Medical devices (manufacturers’ evidence of conformity)
Medical devices (product overlaps in the NZ and Australian markets)
Biological and blood products
Biologicals & fresh blood and blood components (analysis of NZ sector)
Biologicals & fresh blood and blood components (GMP codes & standards)
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Content last updated: 13 November 2013
Content last reviewed: 13 November 2013
Web page last updated: 13 November 2013
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