Asia-Pacific Roundup: Australia seeks feedback on making references to TGA in product advertising

RoundupsRoundups | 27 September 2022 |  By 

Australia is holding a consultation on whether to allow advertisers to make references to the Therapeutic Goods Administration (TGA) in their promotional materials. TGA is seeking feedback on a wide range of options, from maintaining the current prohibition through to different, more permissive approaches. 
 
Currently, advertisements to the public cannot suggest or imply that a product has been approved or endorsed by a government agency without authorization. However, TGA is considering allowing advertisements to make references to it to help consumers more easily identify products that can be lawfully supplied in Australia and make informed decisions about the self-selection of medicines and medical devices. TGA thinks the change could also simplify its compliance and enforcement activities.
 
The first question is whether the agency should maintain the status quo or allow companies to make references to TGA in promotional materials. TGA wants to know if relaxing the rules will help consumers identify legally supplied products.
 
The consultation seeks feedback on the limits and specifics of a new regime that allows the use of references to TGA in advertisements. The agency is considering allowing references to TGA in all approved products that are in the Australian Register of Therapeutic Goods (ARTG) and can be advertised to the public. In that scenario, TGA references will be allowed for most medical devices and most over-the-counter medicines.
 
The agency is also considering more restrictive regimes. The other options put forward by TGA are to limit the more relaxed rules to products that have undergone pre-market assessment, or to only allow specific products to make references to the agency. TGA thinks the case-by-case approach might be “appropriate where there is a high risk of unlawful promotion or marketing of unapproved products that have public health importance” because it could help consumers identify lawfully supplied products.
 
The consultation acknowledges that “unscrupulous advertisers could seek to illegally use any such claim to market unapproved products.” However, TGA thinks requiring a reference to the ARTG number will make it “straightforward” to determine if a product is legitimate.
 
Other sections of the consultation paper address what references to TGA could look like, how references could be used in advertising, whether the scheme should be optional or mandatory and how to educate people about the changes. The agency presents three options for how references could look, offering respondents the chance to choose between inserting TGA before the ARTG number, add a statement such as “TGA approved” or use a logo or symbol that indicates the product is authorized.
 
TGA is also seeking feedback on how the references are used. One option is to only allow the display of the TGA reference on product labels, provided it does not distract from mandatory information, and in pack shots. TGA is also considering allowing references in any advertising that complies with the rules of the authorization, reflecting its belief that the option is low risk and would help digital devices.
 
The agency sees benefits to making the scheme mandatory, noting that a voluntary program could lead consumers to incorrectly assume products lacking the reference are not in the ARTG and make its own enforcement programs more challenging. The downside is a mandatory program will impose on sponsors and necessitate a transition period of “several years.”
 
TGA is seeking feedback until 7 November.
 
Consultation Paper
 
India posts draft rules on registering non-sterile, non-measuring Class A medical devices
 
The Indian Ministry of Health and Family Welfare has released draft changes to the medical device rules for consultation. Officials are planning to add a new section on the registration of “Class A (non-sterile and/or non-measuring) medical devices.”
 
Under the rules, manufacturers of medical devices covered by the new chapter will need to register their products by uploading information to an online portal. The draft proposal sets out the information that manufacturers and importers will need to upload, including details of each device such as the intended use.
 
Companies also need to self-certify that the product conforms to the safety and performance essential principles checklist and to the standards prescribed in the Medical Devices Rules, 2017. After providing the information, manufacturers and importers will receive a registration number. Companies covered by the rules need to maintain records of manufacture or import, as well as for sales and distribution.
 
Draft Rules
 
TGA provisionally approves Pfizer’s COVID-19 shot as booster in kids aged 5 years and up
 
TGA has provisionally approved Pfizer’s COVID-19 vaccine Comirnaty as a booster for use in children aged five years and up. The decision to clear the vaccine for use as a booster in children aged five to 11 years comes five months after TGA provisionally authorized it for use in older children.
 
The latest label expansion is the fourth step in the ongoing process of growing the number of people who can receive Comirnaty in Australia. TGA provisionally approved the vaccine in adults as a booster 11 months ago. After three subsequent decisions lowered the minimum booster age, TGA is now assessing whether to authorize the vaccine as a primary course in children as young as six months.
 
TGA is yet to publish the Australian Public Assessment Report on the latest decision. The agency is also evaluating Moderna’s application for booster doses of its Spikevax COVID-19 vaccine for individuals aged 12 years and under.
 
TGA Notice
 
Malaysia’s MDA clarifies postmarket responsibilities in update to medical device guidance
 
Malaysia’s Medical Device Authority (MDA) has revised its guidance on medical device licensing for establishments. The revised version of the guidance includes a section on postmarket responsibilities.
 
In updating its 2016 first edition of the guidance, MDA has added new terms to the glossary and a new section on postmarket responsibilities. The new section requires establishments to comply with 2019 regulations on postmarketing and “continuously ensure the safety and performance of the medical devices in the market throughout the supply chain.”
 
Another new section explains that retailers or tendering agents that carry out manufacturing, import, export and distribution activities will need to obtain the relevant establishment license. MDA has also updated existing sections of the guidance, for example by explaining that details of the person responsible, including proof of identity, need to be uploaded to the MeDC@st 2.0+ online portal.
 
MDA Guidance
 
TGA provides update on incorrect settings, replacement cords for recalled Philips devices 
 
TGA has provided an update on Philips’ recall of sleep apnea and ventilator devices in Australia. After shipping replacement devices with incorrect settings and power cords, Philips is now working to correct the mistakes.
 
Philips has contacted all the patients who received bilevel positive airway pressure machines with the wrong settings. The company is also reviewing replacement continuous positive airway pressure (CPAP) devices to ensure that it installed the correct settings. If Philips discovers incorrect CPAP settings, it will contact the owner to fix the device.
 
TGA also provided an update on the power cords supplied with Philips’ sleep and respiratory devices. The company shipped some products with a “light duty” power cord, rather than the intended “ordinary duty” power cord. While the light duty cord is safe to use in home settings, Philips is contacting patients to offer replacement cords.
 
TGA Notice

 

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