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Regulatory Focus™ > News Articles > 2020 > 7 > Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

Posted 21 July 2020 | By Nick Paul Taylor 

Asia-Pacific Regulatory Roundup: TGA finds ‘clear examples’ of harm linked to medical software

Reviews conducted by Australia’s Therapeutic Goods Administration (TGA) found “clear examples” of harm caused by medical software.
 
TGA searched the medical literature for articles on the safety and efficacy of medical software as part of an assessment of how it regulates the sector. In parallel, the administration reviewed its data, revealing that software faults caused 20% of all medical device recalls over the past five years. While the recalls primarily related to physical devices with software components, TGA said the finding showed the risk of digital products causing “significant and negative health impacts.”
 
In its literature review, TGA found “many app developers have little or no formal medical training,” leading them unknowingly to create products with patient safety issues. In some cases, the problems are severe as “missing malignant cancers.” TGA also identified issues related to limited clinical validation, the categorization of software errors and quality management.
 
The review provides examples of how such failings affect different types of products. For example, TGA found reports of medical calculation apps generating clinically significant errors and of symptom checker programs that failed to match the final diagnosis most of the time. The situation may be worse than it appears because adverse reports can go unpublished, TGA notes.
 
The review did not address how the findings might affect software regulation in Australia; however, TGA did note that the current regulatory framework places “the responsibility of adverse consequences from apps falls on individual clinicians.”
 
TGA Report
 
ASEAN members target hepatitis C, HIV in joint assessment
 
The Association of Southeast Asian Nations (ASEAN) is seeking treatments for hepatitis C, HIV and other diseases for its next joint assessment procedure. Participants in the program stand to access markets, including Malaysia, the Philippines and Singapore through a single submission.
 
ASEAN has piloted joint assessments in recent years with the support of the World Health Organization. The work has set ASEAN up to look for a new candidate to take through the joint assessment process, leading Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) to post a list of 11 therapeutic areas targeted by the association for the next stage of the program.
 
Hepatitis C tops the list. An estimated 400,000 people in Malaysia are infected with hepatitis C, leading the Drugs for Neglected Diseases initiative to make the country a target of its push to boost access to combination therapies featuring sofosbuvir, the active ingredient in Gilead Sciences’ Sovaldi.
 
Putting a hepatitis C drug through the joint assessment procedure could help meet that goal. Drugs that undergo joint assessment are submitted simultaneously to the national regulatory authority of all participating ASEAN members. Regulators collaborate on the assessment and prepare a joint report. Each ASEAN member then uses the information to help decide whether to approve a drug.
 
The process for selecting a joint assessment candidate takes up to 195 calendar days. The joint assessment itself then takes up to 165 to 225 calendar days, depending on whether a meeting is needed. The final decisions by ASEAN members take 30 to 90 working days.
 
Companies with hepatitis C drugs are among the organizations eligible to participate in the program. ASEAN is also targeting HIV drugs, specifically products such as Bristol-Myers Squibb’s Sustiva that are not available in many Asian countries, and treatments for tuberculosis, hepatitis B, treatment-resistant depression and Alzheimer’s disease.
 
NPRA Notice, More
 
Philippine FDA updates position on regulating amid COVID-19 restrictions
 
With the cautious lifting of COVID-19 pandemic restrictions across the Philippines, the Philippine Food and Drug Administration (FDA) is now allowing some activities to occur in person.
 
Companies now may make payments over the counter; however, other activities, such as the submission of complaints, still are prohibited. FDA will give companies 15 calendar days after the lifting of the community quarantine measures to file complaints.  
 
FDA established its original position on regulating under lockdown conditions in mid-March and went on to issue an update two weeks later. In recent weeks, the Philippine government has started easing restrictions, albeit while imposing temporary local lockdowns in response to surges in cases, leading FDA to reconsider its position.
 
FDA Circular
 
TGA shares guidance on advertising to health professionals exclusively
 
TGA has published guidance on how to target advertising at healthcare professionals. Companies can advertise to healthcare professionals online, provided they take precautions to prevent consumers from viewing the promotional materials.
 
Adverts placed in publications that target healthcare professionals, such as Australian Doctor, automatically comply with the prohibition on making promotions accessible to consumers. However, extra precautions are needed when running adverts online, given the materials are more accessible to the public.
 
TGA advises companies to secure the content, so “it can only be accessed by confirmed health professionals.” The guidance features several examples of ways of preventing consumers from accessing the materials.
 
One option is for advertisers to restrict access to people with a username and password. TGA said advertisers could issue the login credentials to people with an Australian Health Practitioner Regulation Agency (AHPRA) registration number, an email address that indicates they work for a health provider, or those who have met with a sales representative.
 
TGA acknowledges some health care professionals may struggle to provide the required information, for example, because they are not regulated by AHPRA and work in a setting other than a hospital or clinic. Advertisers can grant login details to people in such situations based on declarations from the worker or employer. 
 
TGA Guidance
 
India’s NPPA triples expected need for dexamethasone tablets
 
India’s National Pharmaceutical Pricing Authority (NPPA) has tripled its expected requirement for the steroid dexamethasone based on its potential as a treatment for COVID-19.
 
Earlier this month, NPPA told manufacturers India would need 3.3 million dexamethasone tablets through to mid-August. NPPA revised that forecast late last week. The agency now expects India to require 11 million dexamethasone tablets through to the end of August. The forecast represents a sharp increase, even accounting for the extended period covered by the revised outlook.
 
The update comes as the coronavirus continues to spread across India. The country is currently averaging almost 35,000 new cases a day, up from 18,000 at the start of the month.
 
NPPA Notice
 
Other News:
 
TGA has fined Lorna Jane AU$39,600 ($27,700) for alleged unlawful online advertising of “anti-virus activewear.” According to TGA, the company represented its products as being for therapeutic use by claiming they prevent and protect against infectious diseases, implying they are effective against COVID-19. The adverts prompted three infringement notices from TGA. TGA Notice
 
India has lifted its restrictions on the export of certain textiles used in the production of masks and coveralls. DGFT Notice

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