Asia-Pacific Roundup: TGA defies medtech industry by retaining definition of central circulatory system

RoundupsRoundups | 30 November 2021 |  By 

Australia’s Therapeutic Goods Administration (TGA) is keeping its definition of the central circulatory system (CCS) despite universal support for change among medtech respondents to a consultation.
Early this year, TGA sought feedback on plans to remove iliac arteries from the CCS definition. The proposal was intended to align TGA with the definition used in the European Union. By aligning with the regulatory bloc, TGA aimed to decrease the regulatory burden on sponsors of medical devices certified for use in the EU by freeing them from the need to provide additional or different evidence to access the Australian market. TGA predicted the change could increase access to medical devices.
Four medtech sponsors, including BD’s Bard, responded to the consultation. No other organizations provided feedback to TGA during the consultation period. All the responses supported the change, which the medtech sponsors framed as a positive for them and for patients.
“Respondents pointed out that if the inconsistency continued, there would be an extra cost and regulatory burden for approval to include their devices in the Australian Register of Therapeutic Goods,” TGA wrote in its summary of the feedback. “Respondents also noted that Australia is already missing out on a number of these devices due to the cost, processes, documentation and time to meet the differences between these regulatory requirements.”
As the sponsors saw things, changing the CCS definition would improve patient access to medical devices for the treatment of iliac arteries pathologies without increasing risks. However, given the total lack of feedback from groups other than medtech sponsors, TGA “undertook further targeted consultation to understand the clinical implications and risks associated with amending the definition of the CCS by removing iliac arteries from the definition.”
Specifically, TGA asked several clinical colleges and surgical groups to comment on the implications of removing iliac arteries from the CCS definition and thereby lowering the risk classification of certain medical devices. The Australian and New Zealand Society for Vascular Surgery, the Royal Australasian College of Surgeons and the Cardiac Society of Australia and New Zealand voiced strong support for keeping the current definition.
The professional bodies were “concerned that a change may have potential safety implications for devices used in these vessels,” TGA wrote, and called for Australia to remain aligned with guidance from the International Medical Device Regulators Forum. Two Clinical Advisory Groups also said that clinicians definitely view iliac arteries as part of the CCS definition and argued for the retention of the current term.
Faced with a division between sponsors and clinicians, TGA decided to keep the current definition of CCS. The decision means guidewires, stents and catheters that are used in the iliac arteries will still need to undergo TGA’s full conformity assessment. Bard told TGA the high cost of completing the full 24-month technical documentation review process is a barrier to bringing devices to the Australian market.
TGA Consultation
TGA rethinks real-world evidence after review finds barriers to adoption
TGA is working to reduce ambiguity about its use of real-world evidence (RWE) and patient-reported outcomes (PROs) after a review identified the current uncertainty as a potential barrier to adoption.
The review was informed by 50 targeted stakeholder interviews and found evidence that, while RWE already underpins TGA’s postmarket safety work, “There is a less well-developed understanding both internally and externally of how it can be used in pre-market approval of products.” The interviews found TGA needs to better define RWE and PRO, explain how it uses data and develop guidance.
TGA acknowledged that its acceptance of RWE and PROs in submissions has been “insufficiently communicated to some sponsors, healthcare professionals and patient groups.” To improve the situation, TGA plans to make a central point of information on its website to communicate the use of RWE and PROs for pre-market evaluation and consult on the development of guidance.
The agency will also “require applicants to identify why and where RWE and PROs have been included in the application and its purpose for inclusion, as is the case in the USA” and encourage the adoption of “medical device unique device identifiers in the broader healthcare system and specifically, in medical device registries.” TGA sees the registries supporting RWE and PROs.
TGA Notice
After US FDA action, Malaysia’s NPRA rejects bioequivalence studies from 2 sites
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has rejected bioequivalence studies run at Synchron Research Services and Panexcell Clinical Lab after reviewing the findings of its US counterpart.
The US FDA decided to stop accepting clinical and bioanalytical studies run by the sites in September because its inspectors made data integrity observations. The action led NPRA to evaluate its use of data from the Indian contract research organizations and ultimately to reject all bioequivalence tests run at the centers.
With immediate effect, NPRA is rejecting “all application for the Evaluation on the Need for BE Study Inspection (BEDE)” and canceling “all BE study inspection exemptions granted via BEDE applications.” The agency will consider accepting bioequivalence studies to support product registration evaluations after the centers are listed on its BE Centre Compliance Programme.
NPRA Notice
Rise in product names that breach advertising code spurs TGA to restate rules
TGA has reminded sponsors to “carefully consider” the Therapeutic Goods Advertising Code when naming therapeutic goods. The agency issued the notice after seeing “a trend in naming conventions that may be in breach of the Code.”
In the notice, TGA calls for sponsors to pay particular attention to sections 9 and 10 of the Code, which prohibit claims that goods are infallible, unfailing, magical or miraculous. TGA cited products that use terms such as “Calm,” “Fat Be Gone” and “Anxious No More” in their names as examples of how sponsors could breach the Code.
“The TGA understands the need for products to be named in a way that distinguishes one product from other similar items. However, the above examples are likely to result in Australian consumers having a false sense of security about the safety of those products,” the agency wrote.
TGA said sponsors of medicinal cannabis products, nicotine vaping products and weight-loss products have contributed to the recent rise in breaches of the Code.
TGA Notice
Pakistan changes staffing requirements for medical device manufacturing plants
Pakistan has changed the rules on staffing facilities that manufacture medical devices. The new rules may be less prescriptive than the old requirements and could thereby give manufacturers more flexibility.
Previously, the Drug Regulatory Authority of Pakistan (DRAP) required manufacturers to have at least one full-time employee who has a degree in pharmacy or biomedical engineering from a recognized institution and at least four years experience in the production of medical devices or pharmaceuticals. That person needed to be part of a technical staff that was in charge of production.
The new text states manufacturers need an employee with “relevant qualification and experience as deemed appropriate by the MDB.” DRAP’s Medical Device Board goes by the initials MDB.
Pakistani authorities have also changed the rules on staffing quality control departments. Again, the change replaces the requirement for the person in charge to have specific qualifications with a wider call for them to possess relevant qualifications and experience.
DRAP Notice


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