Asia-Pacific Roundup: Australia’s TGA seeks feedback on proposed medical device application audit framework

Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into its framework for auditing medical device applications, in light of changing EU regulations, industry concerns and other factors.

Medical device developers need to apply to include products in the Australian Register of Therapeutic Goods (ARTG) before bringing them to market in the country. TGA assesses all applications against the regulatory requirements set out in two sets of legislation but selects some submissions for a more thorough assessment known as an audit.

Today, certain classes of high-risk devices undergo mandatory audits. TGA can select all other products for non-mandatory audits. The administration spends up to 20 days triaging applications to assess if a level 1 or level 2 audit is needed. Sponsors need to submit the most information for level 2 audits.

TGA has operated under interim processes for reviewing European Union Medical Device and In Vitro Diagnostic Regulation (MDR/IVDR) applications since July 2021. The administration treats MDR and IVDR submissions for lower-class devices the same as other applications, selecting some for non-mandatory audits “based on postmarket intelligence and information in the application.”

The proportion of Class III EU MDR applications selected for non-mandatory audit has steadily declined, falling from 65% in 2021 to 36% last year. The effect of the EU regulations, coupled with factors including industry concerns “about existing processes, timeframes and predictability,” have led TGA to review how it selects applications for non-mandatory audit.

TGA has proposed a new application audit framework that is designed to be more responsive, and risk-based. The administration will select applications for audit “based on postmarket signals, regulatory reforms and regulatory intelligence” and aim to “provide more predictability and transparency regarding types of applications likely to be selected for audit, their focus and expected timeframes.”

Officials have shared eight key elements for the proposed framework. More transparency is the first element. TGA plans to “publish a set of risk factors that influence the likelihood that a medical device will be selected for non-mandatory audit.” The risks, which TGA will update at least every two years, will cover regulation and approval, the quality of the clinical evidence, and the sponsor, manufacturer or type of device. TGA provided a detailed look at the risks it is considering in the consultation document.

TGA is also proposing to explore pathways for Class III devices supported by the Medical Device Single Audit Program (MDSAP) and US Food and Drug Administration (FDA) 510(k) clearance. Because some medical devices that are Class III devices in Australia have a lower classification overseas, sponsors cannot use conformity assessment evidence from comparable overseas regulators.

The administration is proposing to help those sponsors. Through the consultation, TGA is seeking feedback on “whether it would be worthwhile establishing a pathway for Class III medical devices based on MDSAP certification and US FDA 510(k) approval” and on “the merits or risks of establishing a pathway for Class III medical devices based on MDSAP certification and US FDA 510(k) approval.”

Other questions put forward by TGA in the consultation cover whether to limit mandatory audits to high-risk devices, remove the mandatory audit requirement for all medical devices with premarket approval from FDA and limit the number of substantial review rounds to two.

TGA is accepting feedback on the draft until 4 September.

TGA Consultation

Pakistan’s DRAP starts consultation on harmonizing healthcare marketing data submissions

The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on its proposed strategy for the systematic submission of data on marketing to healthcare professionals.

DRAP established the Ethical Marketing to Healthcare Professionals Rules in 2021. The rules are intended to ensure transparency, prevent corrupt practices and facilitate medical decisions that are in the best interests of patients. Under the rules, companies must submit details of their marketing spending and an annual compliance certificate.

The draft documents published last week are intended to help companies comply with the submission requirements and standardize filings. One of the documents is a short certificate of compliance for companies to sign. The other document is a template for details of healthcare marketing spending.

DRAP’s template features a table in which companies can list the institutes and healthcare professionals they have worked with for the purpose of marketing. Companies should state how much they spent on each beneficiary and which category, such as consulting arrangements or business meetings, the outlay covers. DRAP expects companies to keep correspondence, invoices and other relevant records.

The document also includes a promotional expenditure form. DRAP created the form to help sponsors to share details of their turnover during the past financial year and how much they spent on each type of promotional activity, such as electronic ads, promotional printed materials and educational items.

DRAP Notice

WHO enlists India to help identify the source of mystery contaminated cough syrup

The World Health Organization (WHO) has issued an alert about another cough syrup contaminated with diethylene glycol. The syrup was found in Cameroon and lists a company in England as the marketer, but WHO has reportedly contacted authorities in India to help with its investigation.

Cameroon issued an alert about a cough syrup linked to the deaths of six children in April. An analysis at a WHO-contracted and prequalified laboratory found samples of the product, Naturcold Syrup, contained up to 28.6% diethylene glycol. The acceptable limit for the contaminant, which can cause serious injury or death, is 0.10%.

Because the stated marketer is the England-based Fraken International, WHO initially contacted the Medicines and Healthcare products Regulatory Agency (MHRA). However, MHRA confirmed that there is no manufacturer in the UK.

WHO has asked Indian authorities to help, according to Reuters. The UN agency previously identified India-based companies as the source of other contaminated cough syrups and has reportedly written to officials in the country for help contacting businesses that may have been involved in the production of Naturcold Syrup. WHO has also contacted officials in other countries.

WHO Notice, Reuters

Malaysia’s NPRA warns of risk statins may induce or aggravate myasthenia gravis

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published a warning about the risk that statins may induce or aggravate the autoimmune disorder myasthenia gravis.

The European Medicines Agency’s pharmacovigilance committee recommended adding details of the risk of myasthenia gravis to the labels of statins in January. The proposed text explained that “few cases” of new or aggravated myasthenia gravis linked to statins have been reported. There are also reports of recurrences when the same or different statins are given after an initial adverse event.

NPRA’s database contains no reported cases of myasthenia gravis associated with statin use. However, the database does include reports of muscular weakness, muscle fatigue and double vision, symptoms that are associated with the autoimmune disorder.

The Malaysian regulatory agency is still reviewing the safety issue but has seen enough to ask healthcare professionals to be aware of reports linking statins to myasthenia gravis. NPRA is recommending that patients seek medical attention if they exhibit symptoms of the disorder.

NPRA Notice

Asia-Pacific Roundup: Australia’s TGA seeks feedback on proposed medical device application audit framework

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