Asia-Pacific Roundup: TGA seeks feedback on changes to medicinal maggot regulation

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into maggots used in the treatment of chronic and non-healing wounds.

TGA said the use of medicinal maggots, which was first documented in the Old Testament, has increased in recent years because of high rates of antimicrobial resistance and chronic wounds. Researchers and clinicians are now seeking access to medicinal maggots as a potentially life-or-limb saving treatment, TGA said. The rise in demand has revealed a problem with the regulation of medicinal maggots.

A 2017 update to Australia’s regulatory framework categorized “goods that comprise or contain live animal cells, tissues, or organs” as Class 4 biologicals. The clarification was aimed at gene-modified cell therapies and xenotransplant products. Yet maggots and other whole organisms were also captured by the definition, forcing TGA to apply a high level of regulatory oversight to the treatments.

TGA has proposed reclassifying medicinal maggots to be Class 2 biologicals to better match their risk profile and therapeutic use. The agency said the risks of the manufacturing process, which involves the growth, harvesting, sterilization, and aseptic packaging of maggots, are similar to other current Class 2 biologicals such as minimally manipulated human cells and tissues.

The agency is seeking feedback on whether it should reclassify maggots to Class 2, the likely impact of reclassification, and the wording of the update. TGA wants to know if the wording should restrict the use of maggots to debridement therapy, a type of wound healing treatment, or leave the intended clinical use at the discretion of the treating physician. No reclassification transition period is planned.

Officials proposed the update alongside a two-year good manufacturing practice (GMP) exemption. TGA said “current GMP exemptions for domestic medicinal maggot manufacture are highly restricted, underscoring the need for a transitional GMP exemption to support manufacturers, patient access, and ongoing supply.” No Australian maggot facilities hold a GMP license from TGA.

The agency has proposed exempting facilities where a medical practitioner or suitably qualified person make medicinal maggots for use at public or private institutions in Australia from GMP requirements for two years. The change could enable the supply of medicinal maggots via the authorized prescriber pathway, rather than just via the special access scheme.

TGA said the exemption is intended “to support the maturation of the sector, with an expectation that manufacturers will work towards a GMP license.” The agency is unlikely to extend the exemption. TGA wants to know if there is support for the exemption and whether the transition period is long enough for manufacturers to achieve a GMP license.

The consultation closes on 10 December.

TGA Consultation

NPRA discusses fallout from outage of Malaysia’s registration and licensing platform

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has explained what companies need to do to fix problems created by an outage of its registration and licensing platform.

A technical issue with QUEST3+ recently caused a system outage. While the portal is now working, NPRA said data can only be accessed until 6 November. The data update process stopped 7 November. The problem means companies that entered data starting on 7 November need to take certain actions.

NPRA has asked companies that submitted applications involving payments to file a complaint ticket. The agency will update the product status upon confirmation that it has received the payment associated with a filing. Users who filed status change applications that do not involve a fee should open a ticket to allow NPRA to review and update their data.

The agency has asked companies that filed applications that do not involve status changes to re-enter any missing data. Applicants need to re-enter the data to ensure the system records are complete and valid, NPRA said.

NPRA Notice (Malay)

Malaysia’s MDA asks companies to take timely action on device classification changes

Malaysia’s Medical Device Authority (MDA) has advised manufacturers to take timely action to ensure a smooth transition to new product classification requirements.

As of 1 May, all newly issued product classification letters are valid for two years. The validity period is intended to ensure alignment with the latest regulatory requirements and facilitate better industry compliance, MDA said. The impact of the change depends on when existing letters were issued, as MDA explained in its notice.

Letters issued before 1 January 2020 are no longer valid and holders need to file a new application to sell the devices. Letters issued from the start of 2020 to the end of 2023 are invalid but can be renewed. All letters issued between the start of 2024 and 31 May 2025 are valid until 1 May 2027.

MDA has set 1 May 2027 as the date that the new product classification letter framework will take full effect. The agency has advised affected companies to “take note of this change and ensure timely action for any necessary regulatory processes before the expiry of their product classification letters.”

MDA Notice

New Zealand’s Medsafe orders independent tests of Estradot as complaints continue

New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) has contracted a government lab to independently test batches of Sandoz’s Estradot patches.

In recent weeks, Medsafe and Sandoz have investigated complaints about the efficacy and adhesiveness of the patches, which deliver estrogen to treat menopause symptoms. The investigations have found no evidence of deviations from production, storage, and transportation requirements or quality defects that would warrant a recall. Yet Medsafe has continued to receive complaints from users of the patches.

Medsafe has responded to the ongoing complaints by contracting the New Zealand Institute for Public Health and Forensic Science to independently test Estradot batches that are being used in the country. The agency said the testing “may take some time.”

As it stands, Medsafe has no evidence of a quality defect or evidence that any batch is faulty or warrants a recall. The agency is recommending that women who are not experiencing issues with Estradot keep using the patches.

Medsafe Update

TGA shares international Predetermined Change Control Plans guidance for consultation

TGA has shared an international consultation into the essential principles and content of Predetermined Change Control Plans (PCCPs).

The International Medical Device Regulators Forum (IMDRF) published the draft to facilitate international convergence and harmonize approaches for PCCPs. Regulatory agencies have proposed PCCPs as a way to support ongoing updates to software as a medical device by agreeing certain planned modifications with the manufacturer in advance.

IMDRF said implementation of PCCPs may vary across different regulatory jurisdictions, leading it to draft essential principles to harmonize approaches. TGA said the proposed framework is “broad but harmonized and is intended to allow jurisdictions to tailor the proposed concepts to suit their unique regulatory environments.”

The consultation is open until 8 December.

TGA Notice, Draft Document

Other News:

Leaders from the National Medical Products Administration (NMPA) and the World Health Organization (WHO) met to discuss China’s preparations for vaccine WHO Listed Authority (WLA) assessment. China’s NMPA is actively preparing for the vaccine WLA assessment. Other NMPA leaders met with Indonesian regulators to discuss opportunities for cooperation on drug regulation, NMPA Notice, More

MDA told the Malaysian public to ensure every medical device they buy is registered and sold by a company with a valid license. MDA Notice

Asia-Pacific Roundup: TGA seeks feedback on changes to medicinal maggot regulation

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