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Regulatory Focus™ > News Articles > 2021 > 3 > Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases

Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases

Posted 23 March 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA posts guidance to support self-testing for infectious diseases

Australia’s Therapeutic Goods Administration (TGA) has released guidance documents to support the expansion of self-testing in Australia, addressing clinical performance requirements and risk mitigation strategies for self-tests for seasonal influenza, hepatitis B and C, and chlamydia, gonorrhoea and syphilis.
 
Australia banned self-testing for serious diseases in 2010. An exception was granted for self-tests for HIV in 2014 but otherwise testing for serious diseases continued to require the involvement of a healthcare professional. With the original ban needing to be remade after 10 years under Australian law, TGA sought feedback on allowing self-testing against more diseases in 2019. Positive feedback led a change in the law last year.
 
Now, TGA has released three guidance documents aimed at companies that want to take advantage of the more permissive rules on self-testing. The documents discuss clinical requirements, usability studies, risks and mitigation strategies for self-tests of three different sets of infectious diseases.
 
In the influenza guidance, TGA states that self-tests must have an overall clinical sensitivity of at least 85% and an overall clinical specificity of at least 95%. TGA expects the sensitivity and specificity of self-tests used to analyze samples taken in the four days following the onset of symptoms to exceed 95%. Viral shedding is at its peak over those days.
 
TGA also expects test developers to show that samples taken by the consumers who will use the test are suitable for analysis. The requirement is part of a broader focus on the usability of self-tests. TGA wants self-test developers to assess the ability of users to interpret the instructions for use, the rate of operational errors and test system failures, and inter-reader variability.
 
Self-test developers also need to identify risks. The guidance states influenza false negatives are most likely to occur with self-tests when the sample is taken more than four days after the onset of symptoms. TGA is most concerned about false positives at the start and end of the flu season, when the prevalence of the virus in the community is low.
 
To mitigate risks, TGA wants companies to develop straightforward sample collection processes and demonstrate the stability of their products across a range of conditions. Those risk-mitigation actions also feature in the guidance on self-tests for hepatitis and the sexually transmitted infections (STIs) but in other areas the documents diverge. 
 
For example, the clinical performance requirements are more stringent for the STI and, in particular, hepatitis tests. The risks differ, too, with TGA noting that antibody tests for syphilis may deliver false positives due to cross-reactivity with other pathogens. TGA also named the challenge of encouraging or implementing follow-up STI testing as a risk in the self-test environment.
 
Despite the risks, TGA said the benefits of self-testing for the three STIs and hepatitis B and C may outweigh the risks. The risk-benefit profile will be most favorable for self-tests with high levels of clinical sensitivity and specificity.
 
The guidance clarifies what test developers need to do to bring products to market. It remains to be seen how quickly companies take advantage of the new self-testing opportunities, TGA permitted self-testing for HIV in 2014 but only approved the first kit for use in Australia in 2018.
 
Influenza Guide, STI Guide, Hepatitis Guide
 

AstraZeneca COVID-19 vaccine clears Australian expert review of anaphylaxis risk

 An independent panel of experts convened by TGA has found no increased risk of anaphylaxis linked to COVID-19 Vaccine AstraZeneca. TGA asked the experts to review the data after four anaphylaxis cases were reported in two days in recipients of the vaccine in Queensland.
 
Only one of seven reported cases met the definition of anaphylaxis; others may have been allergic reactions or immediate stress responses to vaccination, the experts noted.
 
TGA said cases of anaphylaxis-like events still need monitoring and immunization providers should give adrenaline when they feel it is clinically required. Vaccines can cause anaphylaxis as a very rare side effect but, despite the apparent flurry of cases of the severe allergic reaction, the experts do not think the AstraZeneca product carries any additional risk.
 
TGA shared these findings on the same day as it passed on the results of the higher-profile European reviews of the risk of blood clots associated with AstraZeneca’s vaccine. Those reviews also found no proven link between the vaccine and the adverse event and that the benefits of the product continue to outweigh the risks.
 
Australia, which has bought 50 million doses of the AstraZeneca vaccine, now has local production capacity following TGA’s approval of a Seqirus site to make the product. TGA needed to approve the Australian manufacturing operation to ensure the vaccines it makes have the same composition and performance of the foreign-produced products tested in clinical trials. Approval of the facility comes weeks after Italy blocked the export of 250,000 doses of the AstraZeneca vaccine to Australia.
 
TGA Notice, More
 

DRAP starts searching for new CEO two years after suspending leader

The Drug Regulatory Authority of Pakistan (DRAP) has posted a vacancy announcement for the CEO role nearly two years after the Pakistani government suspended Akhtar Hussain for listing a PhD from an unrecognized institute on his résumé. Hussain’s dismissal was finalized in March 2021, according to news reports.    
 
Asim Rauf has led DRAP since the Hussain’s suspension but the regulator has never run a recruitment process for the role. Hussain also held the role on an acting basis before being appointed as permanent CEO. The government recently signalled its intent to establish a permanent replacement at a hearing into the appointment of Hussain.
 
DRAP took a step towards finding a permanent leader this week by issuing a vacancy announcement. The new leader will need a postgraduate degree in pharmacy or medicine, something that former CEO Hussain appeared to have before the legitimacy of his doctorate was called into question.
 
Other prerequisites include a minimum of 20 years’ experience “in management or pharmaceutical field or regulatory affairs” in the public sector. If no suitable candidates are found in the public sector, DRAP can hire from the private sector. The CEO must be between 45 and 56 years of age. DRAP will hire the CEO for a three-year term that can be extended by one year. 
 
Vacancy Announcement
 

CDSCO reconstitutes sexual harassment complaint committee

India’s Central Drugs Standard Control Organization (CDSCO) has reconstituted an internal sexual harassment complaint committee.
 
In disclosing the panel, CDSCO said the action is a partial modification of an office memo from 2019, although no such notice is listed in the agency’s publicly available records.
 
The reconstituted panel will deal with “the complaints of working women on sexual harassment.” CDSCO has assigned six people to work on the committee. Most of the committee members, including the chairperson, are women.
 
News of the panel comes weeks after the Department of Pharmaceuticals set up a sexual harassment committee. Work on that panel dates back to 2018.
 
CDSCO Notice

 

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