Australia, NZ Again Drop Plan For Joint Therapeutic Product Regulator
This article was originally published in The Tan Sheet
Executive Summary
Australia and New Zealand once again ditch plans for a joint drug, nutritional product and medical device regulator, wiping away all made in three years to harmonize the two countries' regulatory frameworks.
Australia and New Zealand again have ditched plans for a joint drug and medical device regulator, wiping away all efforts made in three years to harmonize the countries' regulatory frameworks.
Peter Dutton and Jonathan Coleman, health ministers for Australia and New Zealand, respectively, said the decision was made after having reviewed the progress made and weighing the costs and benefits to each country if they went ahead with the plan.
The countries will proceed with their own domestic regulatory reform programs.
This is the second time the countries have gone cold on creating the Australia New Zealand Therapeutic Products Agency. They started working on creating a joint drug/device agency back in 2005, but the plans were shelved in 2007 after the bill for ANZTPA did not get rubber-stamped by the New Zealand government (Also see "Therapeutic Product Regulatory Reforms Considered Down Under" - Pink Sheet, 2 Feb, 2009.).
However, the two countries revived plans for the joint agency in 2011 and a July 2016 target had been set for the launch of ANZTPA.
The governments' decision to drop the plans has not come as a surprise though. According to Arthur Brandwood of Brandwood Biomedical, a Sydney-based consultancy specializing in Asia-Pacific regulations, the news "had been anticipated for some time".
"It was never clear what the benefits were to the medical device and diagnostics industry. New Zealand, with a population of 4.5 million, is a small but sophisticated market with advanced health care systems and has a light touch approach to regulation of devices. There is no premarket review and New Zealand relies upon international approvals,” Dr. Brandwood told “The Tan Sheet” sister publication Clinica.
“Combining the country's Medicines and Medical Devices Safety Authority (Medsafe) with Australia's Therapeutic Goods Administration would have added additional regulatory burden in New Zealand and additional costs which would have been borne by industry in both countries," he added.
Harmonized Regulation Remains Goal
It may be that ANZTPA will remain a proposal. However, the health ministers indicated Australia and New Zealand still would work toward some level of harmonized regulation.
"While work on ANZTPA will cease, our two countries will continue to co-operate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country," they said in a joint statement.
TGA and Medsafe will continue to explore other trans-Tasman regulatory harmonization activities that represent potential value to both countries, and that build upon earlier business-to-business projects.
These include developing a new information sharing agreement and formalizing mutual recognition of good manufacturing practice audits. This work will increase the potential for regulatory alignment over time to reduce compliance costs, the ministers stated.
Indeed, Brandwood confirmed the agencies have a long history of close cooperation on post-market regulation, including a shared adverse event reporting system, and on recalls. "ANZTPA was never necessary for this to continue," he said.
(This article first appeared in Clinica
.)