Australia Curbs GMP Inspections As Coronavirus Bites
Regulator Also Updates On Shortage And Vaccine Actions
Executive Summary
The Australian drugs and devices regulator says that international travel curbs relating to the COVID-19 outbreak have forced it to cut back on its inspections of overseas drug manufacturers. It is also looking out for potential drug shortages and will give the “highest priority” to any new drugs and vaccines that are developed for the virus.
Australia’s Therapeutic Goods Administration has suspended good manufacturing practice (GMP) inspections of production plants in certain countries because of COVID-19 travel restrictions imposed by the government.
The TGA can assess manufacturing standards through its GMP clearance and inspection programs, which are risk-based and may involve joint inspections of a manufacturing plant or be based on evidence of GMP adherence provided by international regulators.
However, the COVID-19 outbreak “has resulted in travel restrictions that will affect our ability to perform GMP inspections of overseas manufacturers,” according to the agency. “Currently, due to the Australian government advice, inspections in some countries have been suspended until further notice. Relevant sponsors and manufacturers will be notified if their applications are affected by these restrictions.”
Any travel restrictions implemented by the TGA’s international regulatory partners could also result in delays to their GMP inspections, the agency said, noting that this could affect Australia's GMP clearance reliance program, which involves the desk-top assessment of overseas manufacturers.
The TGA has developed a risk-based desktop assessment process that relies on information from recognized regulators and has reduced the number of overseas on-site inspections that need to be performed.
It conducts two types of desk top to allow it to decide whether to issue a TGA GMP clearance.One is the Mutual Recognition Agreement Pathway, where the TGA accepts GMP Certificates issued by a country with which Australia has a mutual recognition agreement (MRA). The other is the Compliance Verification Pathway, where it can accept evidence from an MRA regulatory authority or a recognized regulatory authority of a country with which Australia does not have an MRA.
The TGA said sponsors had a duty to maintain the validity of their GMP clearances for overseas manufacturers and that where a COVID-19 outbreak resulted in delays to GMP inspections, they should submit an extension application as outlined in the GMP clearance guidance.
“As the situation is constantly evolving, we also encourage sponsors to keep abreast of the latest developments and to contact us if they have any questions or concerns about their overseas manufacturers,” the agency said, noting that there is currently no impact on domestic GMP inspections.
Medicines Supply Issues
The TGA has also given an update on its other activities relating to COVID-19 in areas such as medicines supply and access to tests, drugs and vaccines.
As of 6 March the agency had not received any notifications of drug shortages directly related to the coronavirus outbreak. “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,” it cautioned. Stockpiling by individuals could result in other consumers being unable to access particular medicines, it added.
The agency is closely monitoring the international drug manufacturing situation and working with sponsors, wholesalers and pharmacies to identify any potential future impact on medicines supply. Its national Medicines Shortages Working Group “will be meeting regularly to discuss emerging issues relating to possible shortages and their management.” The working group includes representatives of bodies representing innovator, generic and OTC companies, medicines supply chain organisations, and hospital pharmacy professional organisations.
If there are any medicine shortages relating to COVID-19, including information about the expected duration and the supply of potential alternative products, details will be published on the TGA’s dedicated web page and communicated more widely to healthcare professionals. “We will work closely with sponsors to manage supply and source alternatives where necessary,” the agency added.
Vaccines, Treatments & Tests
Noting that a number of vaccines are under development and that some medicines are being assessed in clinical trials for efficacy against COVID-19, the TGA said that when 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 some cases, doctors may choose to use an unapproved medicine on a particular patient if other treatments are not appropriate or have been shown to be ineffective, using the notification (Special Access Scheme A) and application (Special Access Scheme) pathways.
The health sector emergency response plan for COVID-19 says that the Therapeutic Goods Act has provisions to allow for the importation and supply of products and the use of new disease-specific in vitro diagnostic tests that have not been approved in Australia in cases of potential threat to health.
As for diagnostic tests, the TGA noted that on 31 January 2020, the Therapeutic Goods (Medical Devices - Novel Coronavirus) (Emergency) Exemption 2020 was passed to facilitate access to “certain kinds of medical devices used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of novel coronavirus (COVID-19) infection (in practice, in vitro diagnostic medical devices).”
The agency said these tests had been widely used by members of the Public Health Laboratory Network in testing for COVID-19 in Australian states and territories, and “as the demand for testing has increased a review of the exemption may be considered to allow a wider number of testing laboratories, including certain private laboratories, to have access to the tests.”
As of 17 March, there had been 375 confirmed cases of COVID-19 in Australia, and five deaths, the Department of Health said. A total of 189 of the cases were believed to have been acquired in the US, Iran, Italy and the UK.