Asia-Pacific Roundup: TGA issues draft guidance on pathways for borderline products

The draft guidance from the Australia Therapeutic Goods Administration (TGA) aims to help manufacturers and sponsors determine the status of therapeutic goods “that may not fit clearly within existing definitions for medicines, biologicals or medical devices,” including combination products.

Existing guidance from 2005 needs to be updated because of significant changes that have occurred since then, including the introduction of the biological regulatory framework and the creation of emerging types of products, according to the agency.

The draft guidance provides definitions for medicines, medical devices and biologicals and explains the key therapeutic actions that determine the classification of a therapeutic good.

For example, a “pharmacological” action is typically at “a molecular level between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes,” according to the guidance. A product that achieves or is likely to achieve its principal intended action by pharmacological means meets the definition of a medicine. TGA has based its explanations of different actions on European Union rules.

Boundary products have some of the attributes of two or more categories of regulated goods or have characteristics that mean the appropriate regulatory pathway is not immediately obvious. TGA notes that therapeutic goods that are chemical substances and exert their therapeutic effect through local or systemic chemical means are generally not medical devices and outlines the factors it considers when determining how to regulate boundary products.

The agency considers which component or ingredient provides the most important therapeutic effect, the principal therapeutic effect achieved, and the primary mode of action and how it relates to the definitions of medicine, biological and medical device. TGA looks at a therapeutic good’s scientifically demonstrated action, therapeutic claims, labeling, adverts and dosage form when determining its principal therapeutic effect.

“Medical devices may contain medicinal substances, including herbal and plant extracts and substances derived from human blood or blood plasma, that act on the body in a manner ancillary to the device. However, when such substances act in a manner that is more than ancillary, the product is likely to be regulated as a medicine,” the draft guidance states.

Another section of the draft describes different types of combination products, including three types of medicine-device combinations. The draft lists medicine spoons, prefilled syringes and heparin coated catheters as examples of the three types of medicine-device combinations. In an appendix to the draft, TGA states the appropriate regulatory pathway for a list of boundary and combination products including heparin coated catheters, which it treats as a medical device.

TGA is accepting feedback until 20 November.

TGA Consultation

Japan’s PMDA posts guidance on codes on containers to identify prescription drugs

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of the implementation guidelines for labeling containers with codes to identify prescription drugs.

Last month, the Ministry of Health, Labour and Welfare published guidelines in response to a ministerial order about the amendment of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The new guidelines replace a 2016 notification on the barcode labeling of prescription drugs, which is scheduled to be discontinued at the end of November 2022.

Going forward, Japan’s rules on labeling containers to identify prescription drugs will be covered by the guidelines that PMDA translated into English last week. The guidelines detail the labeling actions that companies should take “to prevent accidents due to mishandling of pharmaceuticals in medical care, to ensure traceability, and to promote efficient distribution of pharmaceuticals.”

The guidelines include tables showing what labeling information is mandatory, under two documents on the topic, and what information is optional. Adding the expiration date and manufacturing code to the unit of dispensing packaging is typically optional, the exception being for specific biological products. The information, plus the product code, must be included on the unit of packaging to be sold under the Act.

Other sections of the guidance address exceptions to the labeling requirements, using and changing the Global Trade Item Number, the barcode symbol system and more. PMDA expects manufacturers to use the GS1 DataBar Limited Composite Symbol with CC-A on dispensing packaging, although it will accept the use of the GS1 DataBar Stacked Composite Symbol with CC-A when the labeling area is small.

PMDA Guidance

TGA lays out options for sponsors after Europe extends validity of GMP certificates

TGA has responded to the extension of the validity of good manufacturing practice (GMP) certificates in the European Union. With the European Medicines Agency (EMA) extending the validity until the end of next year, TGA has created three options for Australian sponsors to maintain GMP clearance validity.

The options cover mutual recognition agreement (MRA) GMP clearances that are set to expire between December 2022 and December 2023. If their current evidence is less than three years old, TGA wants sponsors to submit a renewal application as per the GMP clearance guidance. The agency will assess the application using the existing routine processes.

A different option is open to sponsors with current evidence that is more than 3 years old that have not submitted a renewal application that has been assessed using the risk-based approach. In that scenario, TGA wants sponsors to submit a renewal application as per the GMP clearance guidance. TGA will assess the applications using the risk-based approach it introduced in the November 2021 update.

Finally, if a sponsor’s existing applications have been assessed using the risk-based approach, TGA wants it to submit a renewal application as per the GMP clearance guidance. TGA will align the expiry dates with existing EMA guidance.

The update also covers TGA’s approach to clearances it granted using “distant assessment” evidence to overcome COVID-19 restrictions. The clearances have a shorter expiry. If no current alternate evidence is available, sponsors can apply for an extension. TGA will determine the new expiry dates as per its routine GMP clearance approach or through alignment with EMA, depending on the date of inspection.

TGA Notice

TGA surveys users about the beta version of its adverse event notification database

TGA is running a user experience survey to gather feedback on the beta version of its medicine Database of Adverse Event Notifications (DAEN). The agency has been trialing a beta version designed to address “a decline in the older database's performance and reliability.”

Amid “unprecedented interest in the safety of medicines and vaccines,” the older version of DAEN faced problems including “longer response times and time-out issues.” Having sought to address the problems, TGA is now asking users whether it was easier to find information on the new or older version of DAEN and is otherwise seeking feedback on its beta database.

TGA wants to know what types of devices users used to search the beta version and whether they made use of features such as advanced search filter options and the graph only view. The agency also wants to know if the graphs are useful.

TGA Notice

Asia-Pacific Roundup: TGA issues draft guidance on pathways for borderline products

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