Asia-Pacific Roundup: TGA seeks feedback on risk-based application audit framework for medical devices

Australia’s Therapeutic Goods Administration (TGA) has begun a consultation into two new guidance documents on its risk-based application audit framework for medical devices.

TGA audits application to verify that devices comply with regulatory requirements before they are added to the Australian Register of Therapeutic Goods. Australia changed the regulations last year to limit mandatory application audits to certain pathways.

One new guidance document describes the criteria TGA uses to select applications to audit. The agency will select applications if it has “ongoing concerns about the device that may have been raised during preliminary assessment.” TGA said concerns about whether the “device” meets the Australian definition of a medicine and conditions imposed by foreign regulators can trigger audits.

“If you believe your device is likely to be selected for audit because it meets one of the above criteria, you may consider attaching a cover letter providing more information and explaining the implications of any differences between the comparable overseas regulator approval and your application,” TGA wrote.

TGA will also look at the regulatory history of a device when deciding whether to select an application for audit. Devices that were previously submitted to TGA but then withdrawn, refused, or left pending with unresolved safety or performance concerns could be picked for audit. TGA said devices with unresolved concerns are likely to be selected, even if the applications are made by different sponsors.

Certain types of devices affected by Australian regulatory reforms will be selected for non-mandatory audits. The list includes companion diagnostics, medical device software and artificial intelligence, and patient-matched medical devices. The type of evidence from comparable overseas regulators can affect TGA’s decisions too. Transcatheter heart valves without U.S. premarket approval will be chosen for audit.

Postmarket signals and factors related to the sponsor or manufacturer may also influence TGA. The agency will pick devices that have been the subject of postmarket reviews, such as breast implants and surgical mesh, for audits. Companies with “a broad and consistent history of submitting non-compliant medical device applications to the TGA, or of supplying unsafe medical devices” are likely to be audited.

TGA published the guidance alongside a document about the case management process for medical device application audits. The second guidance document describes what will happen during an audit, including the role of the TGA case manager and the timeframe for completing the process. TGA plans to give companies 20-40 business days to respond to deficiencies it finds during an audit.

The agency is seeking feedback on both documents until 17 February.

TGA Consultation

Indian committee reprimands AbbVie for ‘sponsoring foreign vacations’ for healthcare providers

India’s Apex Committee has reprimanded AbbVie for unethical marketing practices, ruling that the drugmaker violated the Indian marketing code by “sponsoring foreign vacations to Monaco and Paris” for 30 healthcare professionals.

The Department of Pharmaceuticals (DoP) received a complaint in May 2024 that featured internal records from AbbVie. According to the complaint, AbbVie provided “travel tickets and hotel accommodations for extravagant pleasure trips under the guise of conferences” in February and March 2024. The trips were taken by 30 doctors connected to AbbVie’s medical aesthetics products Botox and Juvederm.

Pharma companies are forbidden from offering travel and hospitality to healthcare professionals under India’s Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Because the allegations “were severe and explicitly contravened” the code, the DoP forwarded the complaint to the self-regulatory body and set up its own special audit committee.

The self-regulatory body found no irregularities in AbbVie’s actions and exonerated the company. Yet, the special committee reached the opposite conclusion, calling the decision to spend more than 19 million Indian rupees ($223,000) on travel an “explicit contravention” of the rules.

The Apex Committee allowed AbbVie to present its defense at a hearing in September. AbbVie said it formed a professional service agreement with the doctors to compensate them for their services, but the committee found the agreement was “deliberately structured in a vague way.”

According to the committee, the agreement was “a clever ploy to present an impression of compliance with the regulations, while facilitating foreign travel and hotel accommodations funded directly from ... AbbVie’s budget.” The committee said the agreements “do not clarify why such highly trained HCPs need to be provided with foreign travel opportunities to gain knowledge about simple procedures in medical aesthetics, such as administration of Botox and Juvederm.

“There seems to be no justifiable reason for 30 healthcare professionals to journey abroad to Monaco and Paris for this purpose, nor can any prudent person overlook the conclusion that such preferential treatment or largesse towards HCPs will not aid in promotion of ... AbbVie's products,” the committee said.

The committee gave AbbVie a chance to consider “remedial action by extending support to underprivileged patients receiving treatment at government hospitals for an amount equivalent to the violations computed by the special audit team.” AbbVie rejected the offer, the committee said.

Committee Report

CDSCO starts consultation on protocols for evaluating in vitro diagnostic performance

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on protocols for evaluating the quality and performance of in vitro diagnostics (IVDs).

CDSCO drafted the standard evaluation protocols with the Indian Council of Medical Research (ICMR). The protocols are intended to ensure uniformity in the evaluation of IVDs and enable independent verification of manufacturers’ claims about their tests. CDSCO and ICMR have drafted protocols for 14 tests against the chikungunya, dengue, and zika viruses.

The draft protocols describe the preparation of IVD evaluation panels, the choice of reference assay and the sample size needed to verify performance. Other sections cover how to assess lot-to-lot reproducibility and the sensitivity and specificity that tests are expected to achieve. The protocols also include template reports for submitting the results of IVD performance evaluations.

CDSCO and ICMR are seeking feedback on the protocols until 15 February. The organizations will review the feedback after the consultation closes to inform the finalization of the protocols but are yet to share a timeline for completing the process.

CDSCO Consultation

Philippine FDA posts implementing guidelines for new schedule of fees and charges

The Philippine Food and Drug Administration (FDA) is restructuring its fees and charges. FDA said “the flourishing” of the health product industry necessitates “a commensurate increase” in regulatory fees to ensure the agency can “meet and sustain the increasing demands” of providing services.

Officials have created the guidelines as part of the repeal of an administrative order that has governed fees and charges in the Philippines for more than 20 years. FDA said the new fees are intended to reflect the cost of regulating health products, establishments and facilities to protect consumer safety and public health.

The implementing guidelines state the duration of certificates of product registration — an initial six years for drugs, rising to up to 12 years on renewal — and describe the process for making payments and seeking refunds. The fees for specific regulatory services are listed in annexes to the guidelines.

FDA Guidelines

Other news:

TGA has provided advanced notice of the final package of the recall reforms. Australia is set to implement the reforms in March. TGA Notice

Asia-Pacific Roundup: TGA seeks feedback on risk-based application audit framework for medical devices

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