Australia's Therapeutic Goods Administration and New Zealand's Medsafe have issued a discussion paper setting out the high-level features of the proposed Australia-New Zealand Therapeutic Products Agency scheme, which seeks to establish a joint therapeutic products regulator for the two countries.
IHS Global Insight perspective | |
Significance | The consultation document sets out comprehensive proposals for the regulation of medicines, medical devices, blood products, and biologicals in a format that could be implemented immediately. |
Implications | A window for consumers, healthcare professionals, and industry stakeholders to give feedback on the proposals is open until 21 February 2013. |
Outlook | The goal is for the Australia-New Zealand Therapeutic Products Agency scheme to be operational by 1 July 2016, with discussions regarding the scope of the regulator set to begin in earnest following the release of this document. |
Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe have issued a consultation paper setting out the salient features of the proposed joint trans-Tasman medicines and medical products regulator, the Australia-New Zealand Therapeutic Products Agency (ANZTPA). Comments from members of the public, industry, consumers, healthcare professionals, and other stakeholders have been invited to be submitted by 21 February 2013.
Although there are few surprises, the paper is comprehensive, setting out the proposed regulations in a form that could be implemented immediately. Included are standards for the regulation of medicines, medical devices and in-vitro diagnostics, blood and blood components, and biologicals, as well as planned post-marketing and compliance activities to be carried out by ANZTPA.
The proposals are broadly similar to Australia's current TGA standards. All medicines are classed as either Class 1 low-risk drugs, or Class 2 high-risk drugs, with approval for Class 1 drugs based on certifications from the applicant, while approval of Class 2 drugs will require pre-market evaluation undertaken by the ANZTPA. Similarly, biologicals would be grouped into four risk classifications, as would medical devices, along similar principles to those currently in place in Australia. The regulator will have the capacity to suspend or revoke manufacturing licences where applicable. For all products, the agency will act as the control point for imports and supply into both countries, and to ensure the quality of exports. Proposals for a post-market surveillance system, compliance testing, and adverse event reporting are also set out. The document notes that the future role of ANZTPA in relation to regulating advertising of therapeutic products and the scheduling of medicines will both be addressed and published for consultation at a later date. For a link to the document on ANZTPA's website, see here.
Outlook and implications
Plans for a joint trans-Tasman regulator were first discussed in 1996, but medicines and medical devices were left out of the 1998 Trans Tasman Mutual Recognition Arrangement treaty between Australia and New Zealand. A separate 2003 treaty established the goal of a single drug and device regulator, but progress towards this was thwarted by political opposition in New Zealand, where it was feared that Australia's more stringent TGA guidelines would mean complementary medicines becoming more expensive or unavailable (see Australia - New Zealand: 17 July 2007: Plans for Joint Agency Between Australia and New Zealand Suspended). The current consultation paper states that the content of the proposed regulations have been formulated along the same lines as those drawn up in 2006 before the 2007 postponement of negotiations, so the process is entering a crucial stage, as vested interests in both countries can state any objections for the first time.
The TGA and Medsafe describe the consultation documents as "a conversation starter", with comments from stakeholders to be taken into account before drawing up a final blueprint for the joint scheme. The goal is for the ANZTPA to provide a "responsive and cost-effective" regime for medical product regulation, consistent with international best practice, which should in theory reduce costs for consumers, the industry, and governments. For the pharma industry, chief concerns will be that a joint regulator does not add to regulatory burdens or delay access to international markets. There is a growing trend towards harmonising national regulatory agencies, with plans in place for Association of Southeast Asian Nations countries to implement region-wide regulations for medical devices by 2015 (see Asia-Pacific: 21 September 2012: Asian Medical Device Industry Associations Form Alliance in Preparation for AMDD). Although the release of the proposal paper is a big step forward, the ANZTPA will still require new legislation to be drawn up and implemented in both countries' parliaments, with 1 July 2016 the date set for completion.
Related articles
- Australia - New Zealand: 5 December 2012: Australia and New Zealand progress towards joint health regulator with ANZTPA website
- Australia - New Zealand: 21 September 2012: Australia and New Zealand Set Up Drug and Medical Device Early-Warning System Ahead of ANZTPA