Asia-Pacific Roundup: Australia’s TGA seeks feedback on planned changes to medicine labels
The Therapeutic Goods Administration (TGA) is conducting a consultation on changes to the labeling of medicines supplied in Australia, which it plans to introduce on 1 October 2026.Currently, the standards TGO 91 and TGO 92 establish the rules for the information that companies must include on the labels of prescription and over-the-counter (OTC) medicines, respectively. The TGA stated that the existing standards have helped make important information easier to find on medicine labels, but that there are opportunities to reduce regulatory burdens and provide medicine sponsors with more clarity.
The agency has outlined its plans to capitalize on those opportunities in a consultation paper. TGA’s goals for the updated rules include supporting increased use of technologies such as QR codes. The agency plans to clarify requirements for including QR codes on medicine labels, including by creating rules on the content that the 2D barcodes link to. The link must go to an unrestricted website controlled by the sponsor.
Other proposals aim to reduce the number of Section 14 exemptions, which sponsors apply for when a specific labeling requirement is not applicable to their medicines. The TGA said sponsors have filed for exemptions when the long-standing branding of non-prescription medicines is non-compliant with TGO 92. In response, the agency proposes defining a “distinguishing mark” in the new standard and allowing sponsors to permit branding on the labels of OTC medicines.
The TGA identified printed plastic ampules as another source of Section 14 exemption requests. The previous standard allowed the product name, name of the active ingredients, and quantity to be abbreviated on plastic ampules due to space constraints. TGO 91 and TGO 92 imposed different rules, leading to exemption requests. TGA has proposed exempting sponsors from the requirement to repeat the name of the active ingredient on plastic ampules when it is clearly included in the name of the medicine.
Other planned changes include updates to the substances and warnings that must be declared on labels. Seeking to align the food and medicine requirements, TGA has proposed adding wheat to the list of substances that must be declared on drug labels. The agency is also planning to revise the requirements for declaring mollusks, tree nuts, lactose, and milk products.
TGA is seeking feedback on the proposals until 24 February 2026.
TGA Consultation
TGA starts consultation into medtech conformity assessment procedures
TGA is seeking feedback on planned changes to conformity assessment procedures for medical devices in Australia.
The agency has put forward eight proposals aimed at simplifying requirements, aligning Australia more closely with international frameworks, and ensuring manufacturers have robust quality management systems. TGA sees the proposals decreasing regulatory compliance costs, accelerating access to medical devices, and minimizing public health and safety risks.
Currently, conformity assessment procedures are complex to navigate due to the multiple parts that may be applied to medical devices, the TGA said. The agency plans to repeal procedures that are rarely used and misaligned with international practices. TGA is also considering whether to repeal the five-year certification period, which was aligned with a European Union policy that is now also under review.
Other procedures could be repealed as part of the TGA’s push to require manufacturers to establish controls over design and development in their quality management systems. TGA has proposed repealing two procedures that lack such controls and giving manufacturers five years to transition to its existing Part 1 full quality assurance procedure.
The agency plans to update its use of Part 1. Seeking to align with EU rules on medium-high risk devices, TGA proposes adding a Part 1 design examination clause to the minimum requirements for Class IIb devices and Class 3 in vitro diagnostics. The proposal applies to implantable and non-implantable Class IIb devices.
Two other proposals address clinical and post-market planning and reporting, as well as the use of the Medical Device Single Audit Program (MDSAP) certification in Australian procedures. The clinical and post-market planning and reporting proposal aims to align the TGA’s processes with European regulations and reduce the time required to identify and address threats to patient safety in Australia.
The MDSAP proposal builds on TGA’s existing acceptance of certification under the International Medical Device Regulators Forum program as part of an applicant’s manufacturer’s evidence. TGA plans to add references to MDSAP to its regulations and clarify details such as the need for the auditor to assess the manufacturer’s compliance with Australian requirements.
Other changes include an attempt to fix a reported lack of Australian manufacturers with appropriately certified quality management systems for some medical devices and clarifications to the classification of reusable surgical instruments. TGA is also seeking feedback on incorporating additional conformity assessment requirements specified in the European regulations and on transition timelines.
The draft is open for consultation until 27 February 2026.
TGA Consultation
Japan’s PMDA shares advice on studying combination prescription drugs
The Pharmaceuticals and Medical Devices Agency (PMDA) has published guidance on running nonclinical studies of certain combinations of prescription drugs in Japan.
PMDA said the document applies to “prescription drugs whose active ingredients and their respective proportions are considered similar to those of combination drugs that have already been approved or to those listed in the Japanese Pharmacopoeia.” The agency named dialysis solutions as an example of a combination prescription drug meeting the definition.
The compositional differences between the approved and investigational products are unlikely to affect efficacy or safety, PMDA said. As such, the agency stated that sponsors may not need to conduct new studies on pharmacological effects or toxicity to support filings for approval in Japan.
Safety and efficacy are unlikely to differ when the content or concentration of each active ingredient is in the range found in approved combination drugs with similar indications, dosage, and administration. If the content or concentration is outside the established range, sponsors may be able to skip nonclinical studies if efficacy or safety can be explained based on existing information or knowledge.
“If the applicant considers that new studies on pharmacological effects or toxicity are not necessary for [marketing authorization application], it is required to explain the rationale for omitting these studies in the application dossier, based on the impact of formulation differences compared to the relevant approved combination drugs, as well as the latest guidelines and published literature,” PMDA said.
PMDA Advice
Philippine FDA posts guidelines on using medical device eServices system
The Philippine Food and Drug Administration (FDA) has published guidelines on moving certificate of medical device notification (CMDN) applications to its eServices Portal System.
The FDA stated that its older ePortal System is an outdated technology that has issues integrating with systems such as electronic payment channels. The outdated features and lack of system updates cause challenges in streamlining application processes, FDA said, leading the agency to develop its eServices Portal System to improve authorization processing.
To support the transition, FDA has published guidelines on filing initial CMDN applications using the new system, checking the status of submissions, and downloading the approved certificate from the portal. The guidelines apply to CMDN initial applications for all class A medical devices. Renewal and variation applications are outside the scope of the document.
FDA published the guidelines alongside a document about automating user account access to its ePortal, ePortal2, and RRDPortal. The agency aims to streamline the process for accessing its portals.
FDA Circular, More
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