Asia-Pacific Roundup: TGA explains new regulations for devices with animal, microbial or recombinant materials

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on its guidance on changes to the regulation of medical devices that contain medicinal substances or materials of animal, microbial or recombinant origin. The new requirements took effect in Australia on 1 July.

The update, which TGA discussed in a public consultation last year, is intended to keep Australia’s requirements aligned with the EU where possible, reduce unnecessary regulatory burdens and support timely access to safe medical devices.

TGA shared draft guidance about the new requirements last week, describing the revisions and explaining what companies need to do. Changes to a classification rule have moved some devices into lower risk classes, TGA said. For example, an intraocular lens containing microbially derived hyaluronic acid is treated as a Class IIb product under the new rules, compared to Class III under the old. Other products, such as surgical mesh, are staying in Class III.

The guidance also covers changes to labeling requirements, explaining that the new regulations limit the number of materials that need to be discussed in the instructions for use. TGA said other revisions affect critical supplier changes. The regulator will no longer list suppliers of raw materials of microbial or recombinant origin on conformity assessment certificates.

“Manufacturers still need to analyze the risks of any changes to these suppliers and update their quality management system and risk management documentation accordingly. These documents must also be available for the TGA to review upon request,” TGA said. “However, this change means that manufacturers will no longer need to advise the TGA of changes involving these suppliers.”

The final set of changes relate to “specified medical devices.” Those changes have expanded the range of evidence from comparable overseas regulators that companies can submit to support device authorizations in Australia. TGA lists approvals and licenses from regulators in the US, Canada, Japan and Singapore as examples of newly acceptable overseas evidence.

Companies that added their devices to the Australian Register of Therapeutic Goods (ARTG) before the new rules took effect have until 1 July 2026 to submit a reclass application. The application is needed to include the devices in the ARTG under the new classification. TGA has provided examples of transition scenarios for devices already in the ARTG.

The administration will process applications from companies that filed to include a Class III device in the ARTG before the rule change as usual. If the device is no longer a Class III device, the company will need to submit a reclass application before 1 July 2026. Companies that submitted a conformity assessment application before 1 July can now use a comparable overseas regulator approval, if they have one, instead. Applications sent on or after 1 July must reflect the new classification rules.

TGA is accepting feedback on the guidance until 9 October.

TGA Consultation

Singapore’s HSA shares SaMD change management program guidance for consultation

Singapore’s Health Sciences Authority (HSA) has published draft guidance on its change management program (CMP) for software as a medical device (SaMD), including products that incorporate machine learning technology.

HSA created the optional CMP regulatory pathway after concluding that the “prevailing regulatory framework may not be suited to accommodate the rapid iterative nature of SaMD.” Developers of SaMD need to adopt a total product life cycle approach to adapt to the ever-changing product while ensuring the device stays relevant, safe, and effective, HSA said. Physical devices are not subject to such ongoing adaptation.

CMP is designed to facilitate timely software update implementation by establishing confidence in a company’s good quality management system practices. The program also allows pre-specified changes, which are in keeping with how the US is approaching SaMD.

HSA said showing robust quality assurance processes are in place “provides assurance that the SaMD is designed, developed, and maintained in a manner that ensures its safety and effectiveness” while giving confidence in pre-specified changes. The goal is to ensure updates are made “in a controlled and systematic manner, without compromising [the SaMD’s] safety or performance,” HSA said.

The HSA guidance describes the regulatory requirements and procedures for CMP submission, including eligibility criteria for enrolling in the program, details of the application process, timeline and fees, and what happens after CMP authorization. The authority is using its standard turnaround times for CMP submissions and is not charging an additional fee for enrolling in the program.

HSA is accepting feedback on the draft until 21 October.

HSA Guidance

TGA creates new quality standards for MDMA and psilocybin, sets January start date

TGA has published quality standards for MDMA and psilocybin. The documents specify minimum quality requirements for active pharmaceutical ingredients and finished products of the psychoactive drugs.

Interest in the therapeutic use of MDMA and psilocybin has increased in recent years as studies have suggested they may have mental health benefits. Australia rescheduled both substances in 2023 to permit their use in clinical trials targeting post-traumatic stress disorder and treatment-resistant depression.

The reclassification and the anticipated increase in supply informed TGA’s decision to release draft MDMA and psilocybin quality standards for consultation in December. TGA finalized the documents last week.

The MDMA document establishes requirements such as assay limits and tests for MDMA hydrochloride and products that contain the ingredient, plus information to be included on the label. The psilocybin text covers the same types of requirements but provides different information for plant-derived and synthetic forms of the ingredient. Synthetic psilocybin is subject to rules on elemental impurities.

TGA will bring the standards into effect on 6 January. Starting then, all MDMA and psilocybin ingredients and finished products that are supplied or made in Australia must comply with the standards. TGA plans to publish guidance to help manufacturers and sponsors understand the requirements.

TGA Notice

Pharmacopoeial Discussion Group starts global membership push after integrating India

The Pharmacopoeial Discussion Group (PDG) has started the next phase of its global expansion initiative, positioning more organizations to join the push to harmonize pharmaceutical standards.

PDG was originally a collaboration between the European Pharmacopoeia, the Japanese Pharmacopoeia and the US Pharmacopeia. In 2021, the group announced work on a pilot project to integrate additional world pharmacopeias. The Indian Pharmacopoeia Commission joined the pilot in 2022 and became the fourth member of PDG in 2023.

Having integrated India, PDG said it plans to welcome additional pharmacopeias as new members over the next couple of years. The organization has invited other world pharmacopeias to visit its website to understand the requirements for joining the group and submit a statement of interest by 15 September. Pharmacopeias need to submit a formal application by the end of the year.

PMDA Notice

Other news:

Malaysia’s Medical Device Authority (MDA) has decided to allow expired CE marks and declarations of conformity to be used in some conformity assessment procedures. MDA said it took the step in light of “the unpredictable timeline and issues with regards to the transition to the EU MDR and IVDR.” MDA Notice

Asia-Pacific Roundup: TGA explains new regulations for devices with animal, microbial or recombinant materials

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