Australian, New Zealand Regulators Lay Out Framework for New Regulatory Agency

Posted 08 January 2013 | By Alexander GaffneyRF News Editor

The governments of Australia and New Zealand have jointly released a new policy paper establishing the proposed framework for the planned future merger of their two healthcare product regulatory agencies-the Therapeutic Goods Administration (TGA) of Australia and New Zealand's Medsafe-into the Australia New Zealand Therapeutic Products Agency (ANZTPA).

The paper, released 8 January 2013, is intended to be "the start of a conversation with stakeholders," regulators explained. "We will continue to engage with stakeholders over the coming months as, subject to final decisions of both governments, we work to finalize draft legislation and develop the detail of the regulatory scheme and its associated business processes. We have a unique opportunity to shape the thinking around the design and operation of the new regulatory scheme and the new regulator ANZTPA."

Prior to the announcement, both regulatory groups had largely been working outside the opinion of stakeholder groups to formalize the foundational aspects of the agreement, which are modeled out of the Trans-Tasman Mutual Recognition Agreement-a sort of regulatory harmonization initiative signed by both countries in 2003.

ANZTPA is scheduled to come into existence in just a few short years. Though it will officially launch on 1 July 2016-roughly 42 months from the time of this article's publication-much work remains to be done in the interim.

The paper lays out six core principles by which regulators hope to run the new agency. The new scheme, it said, will be responsive and cost effective; apply regulations proportionate to a product's level of risk; assess products using an appropriate risk-benefit framework; ensure the accuracy of information presented to the public by regulators and industry; work with states and territories to ensure uniform regulations and harmonize its regulations with its international counterparts.

The scheme is set to regulate a wide range of products, spanning prescription medications, over-the-counter (OTC) medication, vaccines and other biologics, blood and plasma products, medical gases, sunscreens, radiopharmaceuticals, in vitro diagnostics (IVDs) and more general medical devices. The regulation of certain "low-risk natural health and supplementary products" in New Zealand, all of these products will be regulated under the harmonized approach of ANZTPA.

Also to be regulated will be the manufacture of all products, including their quality, containers, presentation and adherence to good manufacturing practices. Manufacturers will be required to be licensed with ANZTPA to operate within the country, regulators said. The paper did not explain the particular process by which manufacturers will need to register with ANZTPA, or if their existing registrations with TGA and Medsafe will carry over. It did explain that licenses would not necessarily be uniform, with conditions imposed on license owners to ensure that certain behavior occurs. Those conditions could subsequently be removed, it said.

The Regulation of Medicines

Regulators also proposed a two-part classification system for medicines. Class 1 designation would be given to low-risk products, while Class 2 designation would be for higher-risk products based on their intrinsic risks, quality risks (sterility, etc) or risks associated with their use. Medications will generally be automatically classified as Class 2 medications unless their application for approval contains a number of certifications declaring that the product meets all applicable standards, contains no unapproved ingredients, makes no unpermitted claims and is properly manufactured.

Products would also be able to obtain provisional approval (as opposed to unconditional approval) for a limited time and under restricted conditions if applicants could show that a product sufficiently met an "overriding clinical need for the medicine to be available."

"Provisional approvals would only be granted for medicines to be used in the prevention or treatment of life-threatening illnesses and where the medicine was likely to provide clinically significant therapeutic benefits to patients over existing treatments," ANZTPA wrote in a statement. "This would allow limited access to a medicine where the potential benefit is considered greater than the risk of non-treatment."

Regulators also said they are in the midst of finalizing data protection agreements which would limit its ability to use "protected information" relating to another medicine. Such data is sometimes used by generic or follow-on products as a means to expedite the approval of their competitor product.

The Regulation of Medical Devices

Medical devices are also a major focus of the document. While Australia has regulated medical devices for years, New Zealand would, for the first time, be subject to a medical device pre-approval regulatory framework under ANZTPA. Currently, it only requires devices to be registered with Medsafe.

The proposed framework largely conforms to global norms, and in particular that of the US's. Products would be classified as either class I (low risk), class IIa (lower-medium risk), class IIb (medium-high risk) or class III (high risk or an implantable medical device).

However, the actual process of obtaining approval will be more similar to the process by which medical devices are approved in the EU. ANZTPA's "conformity assessment" process will essentially require all non-class I medical device manufacturers to prove that their devices meet all standards for manufacturing and quality. The regulator said it expects that a current Mutual Recognition Agreement (MRA) in place between Australia/New Zealand and the EU will continue to allow devices approved in either territory to be marketed in both.

Higher-risk devices (though lower-risk ones are not precluded) may also be subject for an "application audit" by regulators, which they said would involve a check of the product's application and certification.

Regulators also said they would be maintaining a register of product approvals, including the holder, manufacturer, the device nomenclature code, the device's classification, the unique product identifier, the product's intended use and its conditions for approval.

In vitro diagnostic will be subject to a different process than general medical devices, and will involve a separate classification system, ANZTPA said. IVDs will be regulated as either Class 1, 2, 3 or 4 (similar to class I, IIa, IIb or III in risk determination), which divides risk into general public health risk and the personal risk to a patient. Because IVDs are often used to test for pathogens, a product could pose little risk to an individual, but a larger risk to an entire population if information is missed.

The entire document, including more information on blood products, biological, postmarketing surveillance, manufacturing, user fees and adverse event reporting, may be found on ANZTPA's website here (PDF).


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