Asia-Pacific Roundup: TGA seeks volunteers for 12-month medical devices vigilance pilot

Australia's Therapeutic Goods Administration (TGA) is starting a pilot program to identify ways to monitor medical device performance and better oversee product safety.

TGA shared guidance on the postmarket responsibilities of medical device manufacturers and sponsors in April 2022 and updated the document earlier this year. The document outlines sponsors’ requirements to monitor the performance of the devices they supply; receive, update and keep information about their products; and report details of adverse events and performance issues to TGA.

The administration is launching a pilot program to complement its existing postmarket surveillance activities. TGA described what sponsors could get out of the free, voluntary program in a notice about the start of the initiative.

“Sponsors who volunteer have the opportunity to work with us, at the Therapeutic Goods Administration, and learn more about their post-market regulatory requirements. Participants will improve their understanding of whether their processes or procedures are sufficient to ensure compliance with the legislative requirements,” the administration wrote.

TGA is asking sponsors interested in participating in the 12-month program to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT), a questionnaire with links to relevant regulations, intended to help sponsors understand their postmarket obligations. TGA will use the information supplied to choose sponsors for desktop audits, onsite inspections, or both.

The administration said the process will “support regulatory education and compliance,” adding that the information gathered “will shape the ongoing development of this important program and improve the safety of Australian patients using medical devices.”

TGA is running a webinar on 14 September to provide more information about the Medical Devices Vigilance Program (MDVP), its processes and what sponsors can expect if they choose to participate in the pilot. Sponsors who want to participate in the pilot can register for the webinar or email TGA’s MDVP address.

TGA Notice

New Zealand’s Medsafe discusses restrictions on supply of controlled drugs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published an overview of the restrictions on the supply of controlled drugs in its latest Prescriber Update.

The report outlines how Medsafe imposes additional restrictions on the supply of some products because of their potential for harm. Supply of controlled drugs requires individual approval from the New Zealand Minister of Health, unless an exemption or blanket approval is in place, and a Licence to Import Controlled Drugs is needed for each consignment.

“If a particular controlled drug substance or dosage form is not available from the local supply chain, the controlled drug may need to be imported from overseas,” Medsafe wrote. “For controlled drugs which require ministerial approval, ministerial approval must be granted before a Licence to Import Controlled Drugs can be issued.”

As Medsafe explains in the report, the exact requirements vary between different sets of products. For example, the supply of lysergic acid, an essential precursor for the manufacture of LSD, requires ministerial approval, whereas medicinal cannabis is exempt from the ministerial approval requirement but still classed as a controlled drug. Blanket approvals cover some other molecules, including ephedrine.

Medsafe shared details of controlled drug regulation in a report covering several other topics. The regulatory authority used the prescriber report to share an update on reports of persistent serious adverse reactions to fluoroquinolones and issue a call for suspected cases of pancreatitis in recipients of interleukin inhibitors.

Medsafe Update

WHO posts alert on falsified rare disease medicine from Jazz

The World Health Organization (WHO) has posted another medical product alert about falsified Defitelio, a medicine Jazz Pharmaceuticals sells for the treatment of severe hepatic veno-occlusive disease in hematopoietic stem cell transplantation patients.

WHO published the alert after a falsified batch – supplied outside of regulated and authorized channels – was detected in India and Turkey. Jazz told WHO the genuine Lot 20G20A Defitelio was packaged in German/Austrian packaging, while the falsified product used UK/Ireland packaging.

Other evidence of falsification includes the use of an expiry date that does not comply with the registered shelf life and a serial number that is not associated with batch 20G20A. Defitelio is not authorized for use in India or Turkey.

WHO has yet to receive reports of adverse events from the use of the falsified batch. However, the sterility and quality of the falsified products is unknown, and the treatment may be ineffective or cause life-threatening health risks. Safety is a particular concern because Defitelio is given intravenously. WHO advises healthcare professionals not to use the affected products and report adverse events.

This is WHO’s third notice about falsified Defitelio in recent years. WHO posted the first alert in 2020 after falsified and contaminated Defitelio was found in countries including Australia and Malaysia and sent a second notice earlier this year after another falsified batch was discovered in the United Arab Emirates and Kyrgyzstan.

WHO Alert

Australian government approves mercury therapeutic good import, export form

Australia’s Department of Health and Aged Care has approved a TGA form for applying to import or export therapeutic goods that contain mercury.

The roots of the approval date back to 2013, when Australia signed the Minamata Convention on Mercury. The convention is designed to protect humans and the environment from the risks of exposure to mercury, a highly toxic heavy metal that can harm the health of people, ecosystems and wildlife. Australia ratified the convention in 2021 and restricted cross-border trade last year.

TGA responded to the changes by creating an application form for people who want to move mercury therapeutic goods in or out of Australia. The form covers applications to import therapeutic goods from countries that are not signed up to the Minamata Convention, and to export goods to countries that either are or are not party to the restrictions on the trade in mercury.

The Australian government approved the TGA form last week.

TGA Notice

Japanese Pharmacopoeia shares draft diagnostic dye monograph for comment

The Japanese Pharmacopoeia (JP) has released a draft monograph on a dye used in medical diagnostics for consultation. JP is seeking feedback on the draft until 30 November.

The draft describes how to identify indocyanine green, a dye used in medical applications, including tests of cardiac output, liver function and blood flow in the liver. The green injection can also make it easier to see parts of the eye during medical procedures and diagnose problems with blood vessels, blood flow and tissue perfusion.

A US Pharmacopeia reference standard is already available. JP is updating its own position on the dye by releasing a draft monograph for consultation. The draft describes how to identify the molecule and other information, including appropriate containers and storage conditions.

PMDA Notice

Other news:

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a notice about the risk of seizures in recipients of cephalosporin antibiotics. NPRA Notice

Asia-Pacific Roundup: TGA seeks volunteers for 12-month medical devices vigilance pilot

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