TGA response to coronavirus (COVID-19)

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

The Therapeutic Goods Act 1989 enables a time-limited exemption of certain kinds of unapproved medical devices (including laboratory tests for COVID-19) so that those devices can be made available urgently to deal with public health emergencies. On 31 January 2020, the Therapeutic Goods (Medical Devices – Novel Coronavirus) (Emergency) Exemption 2020 was made in order to facilitate necessary access to certain kinds of medical devices that are used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of novel coronavirus (COVID-19) infection (in practice, in vitro diagnostic medical devices). These tests have been widely used by members of the Public Health Laboratory Network in testing for COVID-19 in each Australian state and territory, and as the demand for testing has increased, a wider number of testing laboratories, including certain private laboratories have access to the tests.

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.

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