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Regulatory Focus™ > News Articles > 2022 > 5 > Asia-Pacific Roundup: TGA commissions independent report on risks of self-harm from paracetamol misu

Asia-Pacific Roundup: TGA commissions independent report on risks of self-harm from paracetamol misuse

Posted 10 May 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA commissions independent report on risks of self-harm from paracetamol misuse

Australia’s Therapeutic Goods Administration (TGA) has commissioned an independent expert report into the risks of intentional self-poisoning with paracetamol. The report will look at how current access controls for paracetamol manage the risks of self-harm from intentional misuse.
While there are currently no applications to amend the Poisons Standard with respect to paracetamol, TGA wants to gather information to inform considerations about whether any changes to the scheduling, including access or purchasing controls, may be warranted. TGA’s interest in potentially making changes reflects the concerns of the families and healthcare professionals of affected consumers of paracetamol. The concerns center on the number of poisonings and deliberate overdoses from paracetamol.
As those poisonings and overdoses involve paracetamol obtained from general retail outlets, TGA wants to assess whether current access restrictions are appropriate. The current restrictions place limits on the pack size and strengths of paracetamol that can be sold by general retail outlets, such as supermarkets and convenience stores, and through pharmacy or pharmacist-only sales.
TGA wants the panel of experts to assess the incidence of overdosing reports, emergency department presentations, hospital admissions, adverse health outcomes and deaths attributable to paracetamol in Australia. The review will place particular emphasis on events linked to paracetamol bought at general retail outlets and try to compare outcomes to other over-the-counter pain relief medicines.
The experts will also perform a systematic review of medicine overdosing behavior, assess the balance of benefits and risks of current access to paracetamol on the Australian market and look into the possible outcomes of changes to general sale access to paracetamol. TGA has asked the panel to review access controls and paracetamol misuse outside Australia.
TGA is set to publish the report online in July. After that, the agency will hold a public consultation ahead of the Advisory Committee on Medicines Scheduling offering its take on any proposal to amend the Poisons Standard in relation to paracetamol in the second half of the year.
TGA Notice
Malaysia’s MDA finalizes guidance on the rules for classifying medical devices
Malaysia’s Medical Device Authority (MDA) has finalized its guidance on the rules for classifying medical devices, setting out a process for determining the appropriate risk category based on the intended use of a product.
MDA released draft guidance for consultation in February. Most of the final text is unchanged from the draft document, but MDA has added and deleted some sentences after receiving public feedback.
The Malaysian regulator has made a series of changes to its terms and definitions. MDA has completely rewritten its definition of “active therapeutic device” and deleted the terms “ancillary” and “primary intention.” The final guidance also features a revised definition of “surgically invasive medical devices,” which now explains that the term covers products that enter the body through the “mucous membranes of body orifices.”
Elsewhere, MDA has deleted a paragraph about the application of special national rules. The draft listed assessing whether special national rules apply within a particular jurisdiction among the steps for using a rules-based system to classify a device. MDA originally said a different conformity assessment procedure may be indicated when special national rules apply, but deleted the comment from the final guidance.
Other changes include the additions of paragraphs to clarify when noninvasive medical devices fall into Class A and the differences between Class A and Class B nasal solution sprays. MDA also added another caveat to the rule that surgically invasive medical devices intended for transient use are Class B devices. The caveat states that devices such as neuro-endoscopes and brain spatulas that are intended specifically for use in direct contact with the central nervous system are Class D products.
As in the draft text, MDA concludes the final guidance with a series of flow charts based on the rules to help manufacturers determine the appropriate risk category for their medical devices.
Final Guidance
TGA extends label of Gilead’s COVID-19 antiviral Veklury in new provisional approval
TGA has granted provisional approval to Gilead Sciences’ COVID-19 antiviral Veklury in an expanded patient population, extending the label to cover younger children and older, high-risk patients who do not require supplemental oxygen.
Gilead first received provisional approval for Veklury, the trade name for remdesivir, in July 2020. At that time, TGA authorized Gilead to provide the intravenous antiviral for use in adults and adolescents aged 12 years and older and weighing at least 40 kg with pneumonia who have been hospitalized and require oxygen.
The new label expands use of the medicine in two ways. First, TGA has extended the original population of adults and children who weigh at least 40 kg to include patients who do not require supplemental oxygen but are at high risk of progressing to severe COVID-19. Second, Veklury is now authorized for use in children with pneumonia because of SARS-CoV-2 who require supplemental oxygen starting from four weeks of age and a weight of 3 kg.
TGA, which follows the US Food and Drug Administration in granting the two label expansions, based its decision on data from a Phase 2/3 open-arm study in children under 18 years of age and a Phase 3 trial in participants aged 12 years and older weighing over 40 kg.
TGA Notice
NMPA posts guidelines in push to build traditional Chinese medicine evidence system
China’s National Medical Products Administration (NMPA) has published a pair of guidance documents on traditional Chinese medicine as part of its push to establish an evidence system for evaluating and registering the products.
One of the guidelines addresses the clinical development of “new drugs of traditional Chinese medicine compound preparations based on human use experiences.” The second text covers communication under the evidence system for registration and evaluation based on the “combination of traditional Chinese medicine theory, human use experiences and clinical trials.”
The two documents, which came into force late last month, advocate for clinical trials that build on the theoretical basis for traditional Chinese medicine to address outstanding efficacy and safety issues.
NMPA Notice
TGA publishes fact sheet on regulation of digital mental health software
TGA has posted a fact sheet to answer questions about the regulation of digital mental health software. The document covers topics including what it means for software to follow established clinical practice guidelines.
Australia reformed its regulation of software-based medical devices last year, bringing in new rules for software and apps that meet the legislated definition of a medical device. The fact sheet addresses the impact of the changes on developers of digital mental health software, explaining that they are excluded from regulation if they follow established clinical practice guidelines and meet other criteria.
TGA added the fact sheet to a centralized resource that details the requirements that now apply to the software-based medical device industry. The web page brings together a collection of existing documents covering different aspects of the new environment, from a flow chart for determining if software is a medical device through to cybersecurity guidance.
TGA Guidance
Other News:
India’s Central Drugs Standard Control Organization (CDSCO) has extended its flexibility on the rules for the minimum shelf life of imported products. The flexibility will now remain in place until the end of October. CDSCO Notice


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