Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

RoundupsRoundups | 16 July 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Proposes Ban on Certain Breast Implants After Safety Review
Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.
Over the past two months, TGA has performed laboratory testing of breast implants, analyzed sales data and reviewed cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) with a view to establishing the risks associated with each product available in Australia. TGA began the review following decisions by authorities in Canada and France to remove products from the market.
Having completed the review, TGA has preliminarily concluded that some products should be pulled from the market. TGA is proposing to take the strongest action against nine products in Allergan’s line of Natrelle textured breast implants. The cancellation would mean, “The products would no longer be able to be imported, manufactured or exported from Australia” by Allergan. TGA also plans to order the recall of all unused devices but is recommending against removal of already-implanted devices, unless BIA-ALCL is diagnosed in a patient.
TGA is proposing suspending the licenses of a further 16 devices “on the basis that it is likely that there are grounds for cancelling the entries of the products.” The list of devices earmarked for suspension includes seven sold by Johnson & Johnson. Five smaller companies sell the remaining nine devices that are up for suspension.
If TGA goes ahead with the suspensions, J&J and the other affected manufacturers will face the same restrictions as Allergan and its line of canceled Natrelle products. As with the Allergan devices, TGA would recall unused devices.
The difference between the two proposed actions is that suspensions can be revoked. However, for that to happen the manufacturer would need to address concerns “to the TGA’s satisfaction.” If the concerns persist, the suspension may be extended or TGA could escalate the action by cancelling the licenses.
TGA has also proposed imposing conditions on six other textured breast implants, including two sold by Allergan. These actions will require manufacturers to provide a patient leaflet that presents information about the warnings and risks associated with their products.
None of the proposed actions are final. TGA told the affected manufacturers of its plans last week and gave them until 24 July to respond. Once the comment period ends, TGA will prioritize its review of the responses before providing an update on its plans.
TGA Notice
New Zealand Considers Creating Medicinal Cannabis Agency
New Zealand has proposed creating a Medicinal Cannabis Agency. The new agency will perform tasks including the oversight of the medicinal cannabis supply chain, monitoring of compliance with terms of licenses and development of guidance.
With the New Zealand government committed to improving access to medicinal cannabis, work is underway to enable the cultivation and processing of the plant. New Zealand wants to set up a regulatory system to support its medicinal cannabis scheme, for example by creating controls on the cultivation of cannabis crops and the manufacture and supply of products derived from them.
In a public consultation document, the government stated that “the Medicinal Cannabis Agency will be established within the Ministry of Health, as it is the most effective and efficient mechanism to enable the [medicinal cannabis] scheme.” That view reflects the overlap between the planned work on medicinal cannabis and the Ministry of Health’s existing responsibilities for the use of cannabis in non-therapeutic contexts and the licensing of therapies.
“The Ministry can use existing knowledge and expertise, and ensure requirements across therapeutic products and controlled drugs are clear and consistent,” the government wrote in the consultation.
Other parts of the 100-page consultation document address topics including quality standards, the licensing process for manufacturers and importers and postmarket controls. The government spends about 20 pages on quality standards. Across those pages, the government details its plans to regulate the quality of cannabis cultivation, manufacturing, active pharmaceutical ingredients and finished products.
The consultation proposes two ways to regulate the quality of cannabis product manufacturers. Either all these companies will need to comply with good manufacturing practices, or the rules will permit the makers of some products to follow good production practices (GPPs). Canada applies GPPs to nonprescription products containing cannabis.
Officials in New Zealand want the industry to provide feedback on which of the two options they prefer, and submit comments on a host of other questions. The comment period is open until 7 August. The government aims to make the Misuse of Drugs (Medicinal Cannabis) Regulations by the end of the year and start the medicinal cannabis scheme in the first quarter of 2020.
Consultation Document, Government Notice
Industry Divided on TGA Plan to Treat Companion Diagnostics as Class III Devices
TGA has received a mixed response to its proposed regulatory framework for companion diagnostics. While the overall document received broad support, some respondents were critical of specific parts of the proposal such as the plan to treat all companion diagnostics as Class III devices.
In the document released for consultation last year, TGA proposed amending the rules to clearly state that all in vitro diagnostic (IVD) companion diagnostics are Class III devices. TGA felt the change was needed, as the current lack of clarity had permitted some products to be treated as Class II devices, meaning “that they have not undergone an appropriate level of assessment prior to use in Australia.”
Organizations including AbbVie, AusBiotech and Roche pushed back against the plan to automatically group IVD companion diagnostics in Class III. AbbVie, which is concerned divergent Australian regulations would make the country financially unattractive, said it “would like a regulatory pathway that allows sponsors to adopt the classification as determined by the manufacturer.” That desire is partly shaped by AbbVie’s concerns about the impact of non-harmonized global standards.
However, not all respondents shared AbbVie’s concerns about the Class III proposal. Amgen, AstraZeneca and Medicines Australia voiced support for the proposal, while Johnson & Johnson gave it equivocal backing.
Respondents were also divided on TGA’s plans to require unique product identifiers for IVD companion diagnostics. AusBiotech disagreed with the proposal, arguing that, “The current legislation does not require identification of individual Class III IVDs and hence companion diagnostics should not be seen as an exception.” Yet, Amgen supported the concept as it “encourages alignment with overseas regulators to avoid imposition of additional regulatory burden upon industry.”
In its summary of the feedback, TGA said it had received broad support for the implementation of a companion diagnostic regulatory framework. TGA is now working to finalize the proposals, taking into account “suggestions for improvements to specific elements of the framework” submitted during the consultation.
Consultation Responses
Other News
The Philippine Food and Drug Administration (FDA) has found more evidence of counterfeit rabies vaccines. Having issued a warning about counterfeit GlaxoSmithKline vaccines last week, FDA shared a notice this week about five fake versions of a rabies prophylactic sold by Sanofi. FDA released photos showing how to identify the counterfeit versions of Sanofi’s Verorab. FDA Notice
New Zealand is seeking feedback on plans to permit general practitioners to prescribe riluzole to patients who are discharged from specialist services. Consultation Notice


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