Over 30 overseas GMP inspections postponed due to COVID-19 travel restrictions: TGA
The Australian Government announced on March 19 an unprecedented ban on all non-residents arriving into the country which will take place from 10pm (GMT time) on the following day.
Returning Australians, on the other hand, will be subjected to a 14-day self-isolation. Neighbouring country New Zealand also did the same, banning the entry of non-residents from March 19, 11pm (GMT time).
TGA said that in line with the travel restrictions, it had suspended all overseas GMP inspections and Quality Management System (QMS) audits until further notice.
This has led to the postponement of 33 overseas inspections in sites operated by 26 overseas manufacturers, a spokeswoman said in response to queries from NutraIngredients-Asia.
Manufacturers affected mainly come from Asia or the Americas.
“The COVID-19 outbreak has resulted in travel restrictions affecting planned GMP inspections of overseas manufacturers in China, South Korea, United States of America, Thailand, Vietnam, Brazil, and Fiji,” she said.
TGA said the sponsors affected have been contacted, and where applicable, advised about maintaining the validity of their existing GMP clearances.
It added that it was working closely with the international counterparts and would monitor the situation and its impact on GMP inspections and clearances.
Domestic inspections and audits are unaffected, but it added that it would monitor the situation and provide updates if there were any changes.
The regulator assesses the manufacturing standards through its GMP Clearance and Inspection programs.
As of March 18, there are 191,127 reported cases of COVID-19 infection and 7,807 deaths, according to the World Health Organisation’s Situation Report.
Since the onset of COVID-19, regulators have been closing a close eye on issues such as fake product health claims and placing limits on sales of OTC medicines.
In the latter case, the TGA had since announced limits on consumers’ purchase of OTC medicines to a maximum of one unit per purchase.
This is in response to consumers stockpiling on the medicines and pharmacists over-ordering medicines, which have caused some pharmacies and wholesalers to run out of stock of certain products during the first two weeks of March.
As for fake health claims, we recently reported how national regulators from different countries have cautioned manufacturers against making fraudulent health claims linked to the prevention or treatment of the novel coronavirus.