Regulatory Focus™ > News Articles > 2021 > 11 > Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation

Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

Posted 16 November 2021 | By Michael Mezher 

Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that exposed the urgent need for clarification of the classification rule and definitions.
 
TGA’s guidance applies to medical devices that are substances introduced into the human body via a body orifice or applied to the skin. As TGA explains in the document, that definition covers products such as saline solution nasal sprays, wound protection gels and topical creams. All of the products are substances or combinations of substances that are absorbed by or locally dispersed in the human body after being introduced through a body orifice or applied to the skin.
 
The rules on the devices are set to change on 25 November, when TGA will require them to meet the regulatory requirements for Class IIa, Class IIb or Class III products. Devices fall into the highest-risk category if the substance is absorbed systemically, with the lowest-risk group reserved for products that act locally on the skin or nasal or oral cavity.
 
TGA provides examples in the guidance, explaining that throat lozenges, which used to be in Class I, will now be in Class IIa because they are applied in the oral cavity and act locally. The agency cites a vaginal gel that maintains pH balance and weight-loss capsules that expand in the stomach as examples of Class IIb devices. Both types of devices are currently in Class IIa.
 
The examples and broader guidance document discuss the regulatory line between medical devices and medicines. TGA said many products that are devices in other markets are medicines in Australia because, “Their mechanism, including chemical effect in or on the human body can be characterised as pharmacological, metabolic or immunological.” If the action of a throat lozenge is to reduce irritation and symptoms, TGA will treat the product as a medicine.
 
Sponsors of products that meet the definition covered by the guidance can benefit from transitional arrangements. If a device is in the Australian Register of Therapeutic Goods (ARTG) with a start date before 25 November, the sponsor has until 25 May 2022 to tell TGA it has a product that needs to be reclassified. Sponsors then have until 1 November 2024 to submit an application to correct the classification. TGA wants sponsors that are withdrawing devices to cancel ARTG entries by 25 May.
 
The publication of the guidance comes months after TGA held a consultation that exposed “a general misunderstanding” of the types of devices covered by the rule. Most of the responses came from consumers who “misunderstood the intent of the consultation due to social media incorrectly suggesting the consultation was in relation to microchipping individuals.”
 
TGA disregarded the consumer responses but still saw evidence of confusion in the 17 responses from the device and medicine industries. Eleven of the respondents opposed the proposal to refine the regulations but, in TGA’s view, the opposition largely stemmed from misunderstandings, including over the potential for the changes to require sponsors to comply with the medicines regulations.
 
“There is an urgent need to clarify and provide a definition for absorption, chemical action and physical barriers, both of which help determine whether a product should be regulated as a medicine or medical device,” TGA wrote. “The proposed refinements would principally reduce some of the confusion in the language of the device classification rules and avoid any such products being up-classified to the Class III level.”
 
TGA Guidance, Consultation Feedback
 
TGA seeks feedback on creation of regulatory pathway for ‘export only’ biologicals
 
TGA is holding a consultation on potential regulatory options for “export only” biologicals. The idea is to enable the export of biologicals that have different indications, release specifications or labels to the product approved by TGA.
 
Currently, exported biologicals must be identical to the product in the ARTG, even if the differences are approved in the importing country. TGA is considering two changes to the export rules, while also maintaining the option to stick with the current arrangements. The agency is seeking feedback on the preferred option, the confidence of overseas agencies in Australian products and associated fees.
 
The first option is to automatically allow exported biologicals to differ from their ARTG entries in a few ways, such as clinical indication, specifications and shelf life. In that model, the active ingredient, principal manufacturing site and other key attributes must be the same as the ARTG entry.
 
TGA wants to know if the approach provides enough flexibility for sponsors. The alternative is to offer an abridged premarket review for export only biologicals, as is already done for medicines. TGA sees premarket review as a way to give overseas regulators confidence that Australian biologicals meet a minimum level of quality and safety. The third option is to retain the current system.
 
The window for comments is open until 20 December. After that, TGA will review the feedback to inform the Australian government about which regulatory option to support. TGA may hold further consultations to discuss details, including fees and charges.
 
TGA Notice, Consultation Document
 
Indian expert committee tells J&J, Novartis to include 50% government sites in clinical trials
 
India’s Subject Expert Committee (SEC) has told Johnson & Johnson and Novartis to ensure at least half of the clinical trial sites in studies of their pulmonary disease drugs are run by the government.
 
J&J and Novartis separately presented protocols for Phase 2 clinical trials to the committee last week, respectively discussing their plans to study rilematovir in respiratory syncytial virus and CSJ117 in chronic obstructive pulmonary disease. The discussions covered the assessment of risks and benefits, the innovation over existing treatments and the unmet medical need in India.
 
The SEC responded by recommending the approval of the studies, with caveats including a request to include at least 50% government sites. The request is part of a rare set of demands made by the expert committees.
 
India’s Central Drugs Standard Control Organization has published recommendations and minutes from 57 SEC meetings since the start of August, most of which cover multiple clinical trials. Nine of the documents cover conditions related to government sites, typically broad requests to use more but occasionally quantified demands for them to make up 50% or more of all centers. 
 
SEC Recommendations
 
China’s NMPA creates centralized unit for high-throughput sequencing technology
 
China’s National Medical Products Administration (NMPA) is setting up a centralized unit for the standardization of medical high-throughput sequencing technology.
 
In disclosing the plan, NMPA published a document detailing the intent to address standards related to reference genomes, reagents, data analysis software, tumor diagnosis and other areas involved in the medical applications of sequencing technology. NMPA is yet to provide exact details of what the unit will do and over what timeline.
 
The rest of the document lists the 76 people and organizations involved in the initiative. The list features people working in academia, healthcare and industry alongside representatives of Chinese regulatory agencies.
 
NMPA Notice (Chinese)
 
Other News:
 
TGA has issued AU$53,280 ($39,130) in infringement notices over the alleged export, supply and advertising of counterfeit erectile dysfunction medicines. The statement accuses Performance Online Services of supplying products that contain undeclared sildenafil, the active ingredient in Viagra. TGA Notice

 

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