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Regulatory Focus™ > News Articles > 2020 > 9 > Asia-Pacific Roundup: TGA seeks feedback on device adverse events, UDIs

Asia-Pacific Roundup: TGA seeks feedback on device adverse events, UDIs

Posted 29 September 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA seeks feedback on device adverse events, UDIs

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback from the industry and consumers about proposed enhancements to medical device adverse event reporting, posing the same set of questions “through a different lens” to each group.
 
The consultation is split up into five proposals, which include making changes to the current adverse event reporting exemptions and strengthening the reporting requirements.
 
For each proposal, TGA provides an overview of the problem and the options it could take. For example, TGA states the current exemption rules can be misinterpreted “resulting in missed opportunities for timely detection and appropriate action against an adverse event.” TGA wants feedback on whether to remove all or some of the exemptions or simplify jargon to cut the risk of misinterpretation.
 
TGA’s discussion of the potential to strengthen the reporting requirements features three options. One would require a final report to be submitted within a specific period following an adverse event report. Another would mandate that final adverse event reports include the instructions for use, supply data and similar adverse event data for the particular device. The third option addresses standardizing submission formats to streamline data analyses. TGA wants to know if respondents like some or all of the options or want to propose alternative actions.
 
In the UDI consultation, which builds on a feedback gathering exercise TGA ran last year, the agency has asked a series of questions. TGA wants to know what benefits an Australian UDI system will have for the broader health system and whether the first phase of its implementation should be limited to a small number of high-risk devices.
 
The consultation features specific questions about the six broad queries TGA has put to the industry. For example, the agency wants to know if respondents think a limited first phase is a good idea and, if so, how long it should run, and which stakeholders should be involved. TGA also wants respondents to detail the advantages and disadvantages of running a limited first phase of UDI.
 
TGA is accepting feedback on the two consultations until 18 November. 
 
TGA Consultation, More
 
TGA creates service to help drug developers get biowaivers
 
TGA has established an Early Scientific Advice service to enable applicants to seek feedback on specific data before filing to register a medicine. The regulatory service will initially be limited to requests about the biowaivers companies can seek to lower the data requirements for bioequivalent products.
 
Like other regulators, TGA issues biowaivers to developers of medicines that are bioequivalent to existing products. The mechanism allows developers of bioequivalent medicines to bring them to market on the strength of a reduced dataset. However, TGA has identified issues with the system that are preventing biowaivers from improving access to medicines.
 
“The highly technical nature of these requirements means it may not always be clear whether specific data would support a biowaiver justification. Applicants may invest considerable time and resources into developing data that is not needed or may leave out data that is needed. In either case, this may delay access to new medicines for consumers,” TGA wrote.
 
TGA has responded to the situation by establishing the Early Scientific Advice service. Developers of medicines that may be eligible for biowaivers can use the service to get input from TGA, potentially leading to lower R&D costs and improved access to medicines.
 
Companies that want to use the advice service need to send TGA AU$8,570 ($6,070) and complete a request form. After reviewing the request and supporting data, TGA will tell the potential applicant whether the data supports the proposed biowaiver. TGA will give an explanation when it rules the data do not support a biowaiver. TGA is aiming to provide advice within 45 working days.
 
Drug developers that go on to apply to register their medicines in Australia should include TGA’s advice in Module 1 of their dossiers. In some instances, TGA’s advice will be conditional on the acceptability of information missing from the request, such as details of the development of the dissolution method.
 
TGA Notice, Guidance
 
New Zealand modifies warnings for allergens in drugs
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised the wording of warnings that drugs containing allergens need to carry. Medsafe finalized the warnings and gave the industry more time to comply after reviewing 260 responses to a consultation it held last year.
 
In June 2019, Medsafe proposed adding 27 allergens to the Label Statements Database and changing the wording of the warnings for two substances already in the repository. Medsafe put forward the revisions to ensure patients know when medicines contain excipients such as egg, milk and peanut products that can cause allergic reactions.
 
Now Medsafe has removed the word “caution” from the statements to align itself with the rules in Australia, where TGA has been debating how to share information about allergens.
 
Other changes affect the gluten warning. Medsafe is now asking affected manufacturers to identify the source of the gluten and use a lower threshold of 3 parts per million (PPM). The original threshold was 20 ppm.
 
Respondents also told Medsafe the examples of medicines, and groups and classes of products, were too specific. In response, Medsafe has clarified that the list is nonexhaustive by adding the phrase “examples include.”
 
Medsafe had planned to implement the requirements earlier this month but reset its deadlines after receiving pushback from industry. Companies will have to include the statements in new medicine applications from March 2021 onward. Manufacturers of existing products affected by the warnings have until March 2024 to comply.
 
Medsafe Statement
 
India delays implementation of track-and-trace system for medicine exports
 
India’s Directorate General of Foreign Trade (DGFT) has again delayed the implementation of the track-and-trace system for exports of pharmaceuticals and drug consignments. Exporters now have until the start of April to comply with the requirements.
 
DGFT first published details of its track-and-trace system for pharmaceutical and drug consignment exports in 2015. At that time, the requirements were set to take effect over the summer of 2015, with the barcoding of secondary and tertiary packaging becoming mandatory for exports at the start of July. The enforcement of the requirements was first delayed later in 2015.
 
Going into 2020, DGFT planned to start requiring compliance with the track-and-trace system “for export of drug formulation with respect to maintaining the Parent-Child relationship in packaging levels and its uploading on Central Portal” from the start of April. The deadline applied to all drug exporters, including those classed as small-scale industry (SSI).
 
DGFT gave the industry more time to comply in March, when it pushed the deadline back to the start of October for both SSI and non-SSI manufactured drugs. Last week, DGFT issued another delay. The industry now has until April 2021 to comply, six years after the trade body first published details of the procedure for implementing the track-and-trace system.
 
DGFT Notice

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