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TGA response to coronavirus (COVID-19)

19 March 2020

Update 23 March 2020: The 'Access to coronavirus tests, medicines and vaccines' has been updated.

Update 19 March 2020: The 'GMP information for sponsors and manufacturers' has been updated.

As part of the Department of Health, the Therapeutic Goods Administration (TGA) is providing active support for monitoring a number of issues relating to therapeutic goods including medicines and medical devices in response to the novel coronavirus (COVID-19).

Medicine shortages

As of 6 March 2020, the TGA has not received any notifications of medicine shortages in Australia that are a direct result of COVID-19. Therefore, while it may be appropriate for individuals to ensure that they have at least two weeks supply of prescription medicines in the unlikely event they are quarantined, any stockpiling of medicines is unnecessary. Stockpiling by individuals could result in other consumers being unable to access particular medicines (e.g. from their local pharmacy). Stockpiling of any medicines at this time is not indicated and could result in patients not receiving the medicines that they require.

Given the evolving situation, the TGA is closely monitoring international manufacturing of medicines and liaising with Australian medicine sponsors, wholesalers and pharmacists to determine any potential future impact to medicine supply to Australian consumers. The TGA is also part of an active international network of regulators who are meeting regularly to assess medicine shortages, with a focus on availability of medicines associated with COVID-19.

Within Australia, TGA coordinates the national Medicines Shortages Working Group, which comprises innovator and generic prescription and OTC medicines peak bodies, medicines supply chain organisations, medical and community and hospital pharmacy professional organisations, in addition to departmental staff. At this time, the Working Group will be meeting regularly to discuss emerging issues relating to possible shortages and their management.

In Australia, medicines sponsors (companies) are required by law to report current and anticipated shortages of prescription medicines and certain over-the-counter medicines. The TGA publishes shortage notifications for the information of health professionals and consumers. If there are any medicine shortages relating to COVID-19, including information about expected duration and the supply of potential alternative products, details will be published on this web page and also communicated more widely to healthcare professionals. We will work closely with sponsors to manage supply and source alternatives where necessary.

Consumers who are concerned about the impact of COIVD-19 on the supply of their medicines are encouraged to discuss the ongoing management of their condition with their health professional.

As part of the Department of Health, the TGA has also been actively involved in monitoring supplies of face masks in Australia. The Government has also recently organised for release of further masks for healthcare professionals from the national medicines stockpile and supported increases in the local manufacture as well as additional importation of masks

Access to coronavirus tests, medicines and vaccines

A number of COVID-19 IVD tests have undergone an expedited assessment by the TGA and are now included on the Australian Register of Therapeutic Goods (ARTG) for general supply in Australia.

A new emergency exemption, Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories. In practice, this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories while the TGA continues to expedite the regulatory assessment process for these kinds of medical devices.

Accredited pathology laboratories (under the Health Insurance Act 1973) are those accredited as medical testing laboratories eligible for claiming to Medicare for approved pathology services.

NOTE: An emergency exemption was originally made on 31 January 2020, which limited supply of COVID-19 tests that were not already included on the ARTG, to laboratories in the Public Health Laboratory Network (PHLN). Since January 2020, there has been a significant increase in the need to test suspected COVID-19 infections. The new emergency exemption supports increased testing needs by expanding the former emergency exemption to both public and private laboratories in Australia that are appropriately accredited pathology laboratories.

The exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care (POCT), other than to the accredited pathology laboratories specified in the exemption. Although, point of care tests (POCT) that have been included in the Register will be available for broader supply within Australia.

At this stage, there are currently no medicines or vaccines which have been approved by a comparable regulatory authority for the prevention or treatment of COVID-19. However, a number of vaccines are under development and some medicines are currently being assessed in clinical trials for efficacy against COVID-19 infection. When the data from such trials becomes available, Australia is a lead member of a global group of regulatory authorities who will undertake a coordinated review of relevant vaccines and medicines with the highest possible priority.

In certain cases, physicians responsible for the clinical care of patients may choose to use an unapproved medicine on a particular patient if other treatments are not appropriate or have been shown to be ineffective. Notification (Special Access Scheme A) and application (Special Access Scheme) pathways exist for this purpose - for further information see Special Access Scheme.

Advertising of products

The TGA has identified certain therapeutic goods such as complementary medicines or disinfectants being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia.

The advertising of therapeutic goods to consumers in Australia is subject to legislative requirements administered by the TGA. The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation. Consumers are advised to exercise caution when considering advertising claims related to novel coronavirus, and should immediately consult a health professional if they have health concerns.

For further information please see Warning about products claiming to treat or prevent the novel coronavirus.

GMP information for sponsors and manufacturers

The TGA is committed to ensuring that manufacturers meet the requirements of Good Manufacturing Practice (GMP). Manufacturing standards are assessed through the TGA's well-established GMP Clearance and Inspection programs. These programs are risk-based and may involve joint inspections or the use evidence provided by international regulatory authorities.

The COVID-19 outbreak has resulted in travel restrictions that will affect our ability to perform GMP inspections of overseas manufacturers. Consistent with the Australian Government's latest travel restrictions, the Therapeutic Goods Administration (TGA) has suspended all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits until further notice.

The TGA is working closely with our international colleagues and will continue to monitor the situation and impact on GMP inspections and clearances. There is currently no impact on domestic GMP inspections.

Department of Health - Daily Alert

The Department of Health publishes a daily health alert regarding COVID-19 on its website, which provides a range of information and advice about the virus, including what the Government is doing. Please refer to this web page for information about COVID-19 that does not relate specifically to therapeutic goods.