Asia-Pacific Roundup: TGA seeks feedback on flexible formats for medical device instructions for use

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into whether to change the requirements for providing instructions for use (IFU) for medical devices.

TGA currently requires IFU to be provided with the medical device. If the IFU cannot be applied directly to the device, TGA allows sponsors to provide the information on the packaging or in a leaflet supplied with the product. The agency only permits electronic IFU under specific circumstances, such as when a device is only used by healthcare professionals and it is impractical to provide information physically.

Medical device industry bodies have raised the prospect of electronic IFU with the agency. At the same time, TGA has seen the use of electronic communication and digital health literacy increase and other regulators accept electronic IFU in a wider range of circumstances.

Those factors led TGA to hold a consultation into potential changes that it said could help patients stay up to date, reduce regulatory burdens and costs, and cater to consumer preferences. The changes could improve health outcomes if they lead to appropriate use of medical devices, TGA said.

“Providing eIFU for consumers and professional users has the potential to provide benefits for them as well as industry,” TGA said. “Electronic information could be provided in a variety of ways to cater to the audience. Should manufacturers have the option of providing eIFU with their device, it is expected that they would still be required to supply paper IFU without undue delay and free of charge upon request.”

TGA has asked nine questions in the consultation. The agency wants to know if there is support for a new approach to IFU and, if so, how stakeholders want it to update the rules. TGA’s questions cover whether to allow electronic IFU for a wider range of devices for professional users and for consumer devices. The agency has also asked if there are specific devices that should or should not have electronic IFU.

Other questions address practical aspects of switching to electronic IFU, such as how long the materials should be accessible for and how the materials should be stored and accessed. TGA has proposed a set of conditions for the supply of electronic IFU, such as a requirement to undertake risk analysis to show user safety is upheld for devices intended for consumer use.

TGA is seeking feedback on the conditions and other aspects of the proposal until 28 May.

TGA Consultation

Australian regulatory reforms trigger consultation into exempt medical devices

TGA is seeking feedback on potential changes to the regulation of medical devices and other therapeutic goods (OTGs) that are exempt from rules on premarket approval and inclusion in the Australian Register of Therapeutic Goods (ARTG).

Typically, sponsors must get premarket approval or register a product in the ARTG to sell a therapeutic good in Australia. However, products can be exempt when it is impractical to enforce those requirements or when existing risk mitigation strategies are in place. The exemptions apply to devices used in clinical trials, products manufactured as a component of clinical practice and other therapeutic goods.

Recently, work to improve medical device regulations in Australia has “led to an increase in the use of exemptions to remove barriers to supply,” TGA said. Increased use of the flexibility “has highlighted regulatory issues and risks associated with the use of exemptions,” the agency said, and feedback from external stakeholders indicates that in many cases the current arrangements “are not fit-for-purpose.”

TGA spending on exempt products is rising, awareness and compliance with regulatory requirements is low, and a lack of information about the devices poses a risk to patient safety. The agency expects use of exemptions to rise as regulatory changes make the cost of including devices in the ARTG “prohibitive” for some manufacturers, compounding the existing issues.

In response, TGA has proposed to require sponsors to provide information about their businesses and exempt products; publish information about specific exempt medical devices; and empower itself to make sponsors provide information and “a reasonable number of samples” upon request. TGA outlined the case for publishing more information about exempt medical devices.

“Stakeholders including consumers and healthcare providers have expressed a desire for increased transparency and accountability for exempt devices and exempt OTGs through the publication of information, including the capability to identify the sponsor of a product and the specific exemption a device is supplied under,” the agency said.

TGA has asked multiple questions about each proposal to understand whether there is support for the change and identify opportunities to refine the reform. The agency is accepting feedback until 9 June. TGA may undertake additional targeted consultation “with specific cohorts to assess the specific impact of any changes that are made as a result of this consultation.”

TGA Consultation

WHO posts alert about falsified propylene glycol batches found in Pakistan

The World Health Organization (WHO) has published a medical product alert about falsified propylene glycol batches found in Pakistan.

WHO’s alert builds on earlier notices from the Drug Regulatory Authority of Pakistan (DRAP), which found unacceptable levels of ethylene glycol contamination, ranging from 0.76% to 100%, in propylene glycol batches earlier this year. The drums of contaminated excipient were labeled DOW USP/EP PROPYLENE GLYCOL but Dow later said it was not the source of raw materials.

“The quality and safety of these excipients therefore cannot be assured,” WHO said. The health body said the materials “are considered to have been deliberately and fraudulently mislabelled” and contain levels of ethylene glycol that can be toxic if ingested.

WHO’s notice is part of a push to mitigate the risks posed by the excipients. The organization said the “raw materials may have been distributed to other countries, including through informal or unregulated markets,” adding that “manufacturers of oral liquid medicines may have unknowingly purchased these contaminated raw materials, which may still be in their storage facilities.”

WHO is advising manufacturers to source raw materials from qualified and approved suppliers, follow its good manufacturing practice requirements, and test each batch of incoming raw materials for ethylene glycol and diethylene glycol before using them in the production of liquid medicines. Manufacturers that have already shipped drugs made from suspect materials should urge patients to seek medical advice.

WHO Alert

Philippine FDA shares process for bypassing barrier to changing qualified person

The Philippine Food and Drug Administration (FDA) has provided a process for registering a qualified person when they are unable to obtain a resignation letter duly by their former employer.

In 2020, FDA published guidance on how contract research organizations, sponsors and other businesses can change their qualified person. The agency asked for the name of the new qualified person, a valid professional regulation commission ID and a signed letter of resignation if they previously worked at another regulated organization.

Some people have been unable to provide a letter of resignation, leading to the rejection of applications for licenses to operate. The situation has prompted the agency to accept “a duly notarized Affidavit of Undertaking” as an alternative in some circumstances, including “when the pharmacist vehemently denies that he/she has never been employed or connected to any drug establishment.”

FDA Notice

Asia-Pacific Roundup: TGA seeks feedback on flexible formats for medical device instructions for use

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