Regulatory Focus™ > News Articles > 2021 > 8 > Asia-Pacific Roundup: TGA to publish adverse event reports within 14 days

Asia-Pacific Roundup: TGA to publish adverse event reports within 14 days

Posted 24 August 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA to publish adverse event reports within 14 days

Australia’s Therapeutic Goods Administration (TGA) has slashed the time it will take to share adverse event reports with the public, publishing the details of adverse events 14 days after accepting them into its database.
 
Since 2012, TGA has made publicly available the de-identified reports of suspected side effects in its Database of Adverse Event Notifications - medicines (DAEN) 90 days after they are accepted. The lag between acceptance and publication has given TGA time to analyze the data for safety signals. In the interest of greater transparency, the agency began publishing on the quicker schedule on 18 August.
 
“Following the change, more than 30,000 additional reports will be visible in DAEN, reflecting the availability of more recent reports combined with the rate of reporting for COVID-19 vaccine adverse events, arising from the millions of COVID-19 vaccines administered in Australia over a short period of time,” according to TGA.
 
TGA cited “strong public interest in adverse event reports relating to COVID-19 vaccination” as one of the drivers for the new policy, but the change also is underpinned by more long-term considerations. The new timeline brings its approach in line with international practices and aligns with a “Digital Transformation project which over the coming couple of years will digitize, transform and modernize our business systems and infrastructure and allow for greater transparency.”
 
The policy change comes as Australia tries to increase vaccine uptake. To date, around 30% of people aged 16 years and over are fully vaccinated in Australia, putting it near the bottom of the 38 Organisation for Economic Co-operation and Development countries. Australia is aiming to increase its vaccination rate to 70%-80% to end the need for lockdowns but vaccine hesitancy may stand in the way of achieving that objective.
 
TGA Notice
 
Azide impurity in sartan meds sparks recall in Australia
 
TGA is investigating the presence of an azide impurity in sartan medicines. As has happened in other countries, the discovery of low levels of the contaminant in batches of losartan and irbesartan drug products has triggered recalls in Australia.
 
In recent weeks, Arrow Pharma and Link Medical Products have recalled batches of irbesartan and losartan after finding levels of a potentially mutagenic azide impurity at above the acceptable limit. The two recalls affected a total of four batches and led to the quarantining of the affected products.
 
TGA said it is working with sponsors of sartan medicines to investigate the azide impurities and ensure they are addressed. The sponsors now are changing manufacturing processes and establishing controls to keep levels of the impurity below internationally acceptable intake limits.
 
TGA said the risks posed by the impurity at the levels found in the affected batches are very low but the contamination is nonetheless unacceptable.
 
TGA Notice
 
Malaysia posts guidance on remote GMP inspections ahead of policy change
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance on the distant assessment of good manufacturing practices (GMPs) at foreign production facilities. NPRA released the guidance ahead of the 1 September start of a remote assessment program.
 
Faced with pandemic-related travel restrictions, NPRA has been using desktop assessments to extend the GMP statuses of eligible foreign drug manufacturers. However, the use of desktop assessment is limited to manufacturers that have previously been found compliant for the same dosage form and the application at least one year before expiration of GMP status. Producers of biopharmaceuticals are ineligible for desktop assessment.
 
NPRA will continue to conduct desktop assessments of eligible manufacturers but is creating a new option for companies that do not meet the criteria. Distant assessments are open to all foreign GMP applications that are awaiting on-site inspections.
 
The new approach includes a remote review of documents, followed by a virtual inspection. NPRA will use video chat, screen sharing or “or other means of real-time communication” to conduct the virtual inspections. The inspections may include a “virtual tour of aspects of the manufacturer, video communication and interview,” the guidance states.
 
NPRA has set the same fee, RM 20,000 ($4,742), for on-site and virtual inspections, although there are no expenses associated with distant assessments. GMP certificates issued based on distant assessments will last two years, compared to three years for certificates resulting from on-site visits.
 
NPRA Guidance, More
 
Philippine FDA seeks feedback on postmarket surveillance of new drugs
 
The Philippine Food and Drug Administration (FDA) is seeking feedback on the requirements for the postmarket surveillance of new drugs under the three-year “monitored release” registration.
 
New chemicals and existing drug products that have undergone structural modifications are subject to a period of postmarket surveillance under a policy that makes medicines available for monitored release prior to their approval for general use. The existing policy provides some details of real-world data companies need to collect but FDA sees a need for further guidance.
 
The draft guidelines state companies seeking approval of biological and new drug products need to include a risk management plan (RMP). In the RMP, the applicant should set out a pharmacovigilance plan that explains how the company will further characterize the safety of the product, for example by detailing the non-clinical studies, non-interventional trials and other assessments it will perform.
 
FDA is accepting feedback on the draft until 31 August.
 
Draft Guidance
 
TGA shares guide to advertising COVID rapid antigen point-of-care tests
 
TGA has specified what can and cannot be said when advertising COVID-19 rapid antigen tests to the public and released an accompanying guide to the compliant promotion of the diagnostics.
 
One of the documents lists conditions for advertising rapid antigen tests, stating, for example, that promotional materials must say that “negative test results do not exclude infection with COVID-19” and must not infer that PCR testing is not needed. Other restrictions include the prohibition of claims relating to accuracy, specificity, sensitivity or limit of detection and comparisons to other diagnostics.
 
TGA fleshed out the list of what can and cannot be said in an accompanying guidance document. The guidance provides additional details such as an explanation of the thinking behind the ban on the use of testimonials and endorsements to promote COVID-19 rapid antigen tests.
 
Australia allows testimonials and endorsements for certain advertisements of therapeutic goods but has taken a different approach to rapid antigen kits to ensure they “are only advertised as necessary to impart the key capabilities and limitations of the test.”
 
TGA Notice
 
Other news:
 
The Philippine FDA has released a list of class A medical devices. FDA created the list because the wide array of devices on the market means “identifying the risk classification of these health products could be an arduous task for the industry.” Manufacturers of the listed devices need to apply for a Certificate of Medical Device Notif

 

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