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TGA response to coronavirus (COVID-19)

3 August 2020

Update 3 August 2020: The 'Access to coronavirus tests, medicines and vaccines' information below has been updated following the cessation of the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020.

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

Update 19 March 2020: The 'GMP information for sponsors and manufacturers' information below 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

All COVID-19 tests must be assessed and approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) in order to be legally supplied in Australia. The TGA is expediting the assessment all applications for COVID-19 tests.

All COVID-19 test kits approved by the TGA for inclusion in the ARTG are listed on the COVID-19 test kit page.

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.