Asia-Pacific Roundup: TGA seeks feedback on planned reform of therapeutic goods testing regulations

Australia’s Therapeutic Goods Administration (TGA) has shared proposed changes to the procedures for examining, testing and analyzing medicines, biologicals and medical devices.

TGA assessed the current therapeutic goods testing regulations and found that they were not fit for purpose, did not consider the latest innovations and did not meet other criteria for effective policy. Therefore, the agency seeks input on changes to align the testing regulations with the Health Regulatory Policy Framework to protect Australians’ health and safety while minimizing unnecessary compliance burdens.

TGA identified four key problems and suggested eight potential solutions. The agency’s first concern is that the testing framework no longer aligns with the expanded scope of the therapeutic industry or covers emerging innovations. The regulations only apply to certain samples taken by authorized officers or delivered by sponsors.

The agency proposes to remove those restrictions to support testing of “a larger range of sample types regardless of where or how the sample was obtained or provided to the TGA.” All testing of the quality, safety or performance of a good for supply within Australia or for export only would fall under the regulation. TGA also proposes to empower authorized officers to enter company premises.

TGA also identified prescriptive processes that are “inflexible, unclear and burdensome” and proposes to remove them from the regulation and delete information about “unnecessary demarcation” between the roles and responsibilities of various types of analysts. TGA plans to conduct testing according to internal quality management system procedures.

The agency also noted the “use of vague and ambiguous language.” The regulation uses “undefined, but overlapping words like ‘examination,’ ‘testing’ and ‘analysis,’” TGA said, which “causes confusion and uncertainty when attempting to understand the regulatory process.” The agency proposes to update its definitions to reduce confusion.

TGA identified several potential solutions to its third problem. The solutions are intended to address the “complex and inefficient procedures regarding the evidentiary certificate,” which contain the results of TGA tests. The regulation requires the certificates to state whether the goods comply with a relevant quality, safety, efficacy, or performance requirement.

Noting the potential for such determinations to “have significant legal consequences,” TGA proposes freeing analysts from the need to decide whether a product complies with the applicable requirements. Removing compliance decisions from certificates would allow TGA to repeal the review process.

TGA made two other proposals related to the certificates. The agency has suggested only requiring analysts to send a copy of the certificate to the sponsor where the sponsor is identifiable. Under the expanded testing regime proposed in the draft, TGA expects to seize unpackaged or unmarked goods that lack an identifiable sponsor. The other proposal is to remove a restriction on the use of certificates in legal proceedings.

The final problem relates to insufficient staff protection. The regulation makes it an offense to “molest, obstruct, or try to intimidate or influence an authorized officer” but fails to provide the same protection to analysts. TGA said analysts “have been the subject of inappropriate behavior intended to intimidate or influence.” The agency wants to give analysts the same protection as authorized officers.

TGA is accepting feedback on the proposals until 5 August.

TGA Notice

Australian authorities float new approach to ‘boundary’ products in draft proposal

TGA is seeking feedback on the regulation of products that are on the boundaries of different types of therapeutic goods.

The Australian regulator has different pathways and requirements for medicines, biologicals, medical devices and other therapeutic goods. Some products have attributes of two or more of those types of therapeutic goods, putting them on the boundary of multiple categories. TGA shared draft guidance on such boundary products in 2022.

In response, TGA seeks feedback on whether legislation that formally assigns boundary products to certain regulatory categories would provide clarity. The agency published a table of potential categories. Under the plan, an ingested weight loss treatment would be a medical device if it expands to take up space in the stomach but a medicine if it affects calorie absorption by metabolic means.

A second table covers vascular access products and flush syringes. It describes two types of vascular access devices, both of which TGA views as Class IIa medical devices and two types of prefilled saline flush syringes. The agency is proposing to categorize the syringes as Class IIa or Class III devices, depending on whether they contain an active substance such as an antibiotic in addition to saline.

TGA believes the legislation would change the regulatory categories of some products and has proposed a five-year transition period for affected companies. The agency has asked for feedback on whether assigning goods to categories through legislation would provide additional clarity and whether the transition period is long enough for affected sponsors.

The draft is open for comment until 6 August.

TGA Notice

Indian Pharmacopoeia accredited to assess medtech quality management systems

The Indian Pharmacopoeia Commission (IPC) has received accreditation that positions it to assess the quality management systems of medical device companies.

The national accreditation body, the Quality Council of India (QCI), awarded IPC provisional approval as a certification body for two schemes built on ISO requirements. One scheme, ICMED 9000, is based on ISO 9001 for quality management. The other scheme, ICMED 13485, covers the quality management system standard ISO 13485 requirements.

The provisional QCI approval lasts one year and covers non-active medical devices, in vitro diagnostics and sterilization methods for medical devices. IPC received the approval after QCI performed an office assessment and a follow-up evaluation.

QCI developed voluntary programs with the Association of Indian Medical Device Industry to enable medtech companies to show adherence to international standards. The schemes are part of a push for the Indian medical device industry to enhance its credibility overseas.

IPC Notice

New Zealand’s Medsafe shares feedback on antipsychotic ahead of safety discussion

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published the results of a consultation about the risks and benefits of the antipsychotic clozapine.

Medsafe ran the consultation in 2023 to understand local real-life experiences of people who take the drug and their caregivers. The feedback will inform a review of the safety and monitoring requirements for clozapine, a medicine associated with significant benefits and side effects.

The summary of the consultation results shows the frequency of adverse events, focusing on constipation and how they are managed. Medsafe split its summary of the 187 responses between submissions from healthcare professionals and submissions from patients and caregivers.

Officials will present the findings to the Medicines Adverse Reaction Committee. The committee meets four times a year and, based on its usual schedule, will next convene in September.

Medsafe Notice

Other news:

Mundipharma has told TGA it will continue to supply oral opioid capsules in Australia. The update reverses the company's decision to discontinue its Oxynorm products in 2023. TGA Notice

Asia-Pacific Roundup: TGA seeks feedback on planned reform of therapeutic goods testing regulations

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