Asia-Pacific Roundup: Rise in requests drives TGA to prioritize GMP clearances

Australia’s Therapeutic Goods Administration (TGA) is prioritizing the assessment of good manufacturing practice (GMP) clearances over administrative changes because of an increase in the number of submissions it needs to process.
 
While TGA is seeing an increase in administrative change requests – manufacturer name changes, address revisions and the like – it has concurrently seen a greater rise in the volume of applications. To respond, the agency has deprioritized administrative change requests.
 
“We will endeavour to action your transfer request or name change application within a reasonable timeframe, however request patience during this period,” according to a notice from the agency.
 
TGA aims to process requests to transfer less than five GMP Clearances within 10 working days, if it is provided with full contact information of the new sponsor contact person and all the other required documentation. However, the agency warned it is unable to hit that target when handling requests to transfer larger numbers of GMP Clearances. TGA said large transfers may take several months.
 
Given the potential disruption for sponsors, TGA is asking applicants that are seeking to transfer more than 30 GMP Clearances to identify the GMP Clearances that “are the most critical ones for transfer” and share an idea of when they need to complete the transfer “to allow product regulatory actions to be undertaken.”
 
The notice also addresses the timeframe for processing name change requests. TGA is required to contact other sponsors before actioning a name change request. As such, the time TGA takes to action name changes depends on the number of sponsors involved and the number of Australian Register of Therapeutic Goods entries that need to be updated. There is no set timeframe for actioning name changes. Sponsors need a current GMP Clearance to get name changes actioned.
 
TGA Notice
 

Japan’s PMDA details next steps for 3-year-old medical information database

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared plans for development of its medical information database MID-NET. PMDA set up MID-NET three years ago to enable the collection and analysis of large amounts of data from sources such as electronic medical records.
 
The agency marked the anniversary by describing the current system, what it has achieved so far, and plans for further development and use of the database. PMDA plans to improve the accessibility of the technology and expand its capabilities but focused its discussion of the next steps on reinforcing the regulatory utilization of MID-NET.
 
So far, PMDA has primarily used the database to support safety investigations triggered by reports of adverse drug reactions and journal publications. The next step is to use the system more proactively for the routine monitoring of early safety signals before problems are identified by other resources.
 
PMDA used the database for 87 studies from April 2018 to the end of 2020, as well as allowing its use by other organizations on a handful of occasions. The PMDA studies include the assessment of the effect of hepatitis C drugs on blood coagulation in patients on warfarin. PMDA expects to use the system more as the utilization of real-world data increases.
 
PMDA Report
 

COVID breathalyzer tests win provisional authorization in Singapore

Singapore’s Health Sciences Authority (HSA) has granted provisional authorization to two medical devices that are designed to detect COVID-19 infection by analyzing breath samples.
 
COVID-19 testing remains largely reliant on samples taken by swabbing parts of the nose and throat, but researchers have explored other ways of detecting infection such as saliva and exhaled breath. Dutch researchers showed the potential to detect the coronavirus in exhaled breath in February when they posted to the medRxiv preprint server a paper describing a study of their cloud-connected eNose.
 
Now, two Singapore startups have generated the data needed to win provisional authorization in their home market. HSA first cleared Breathonix’s BreFence Go COVID-19 Breath Test System on the strength of a study that found it had 85.3% sensitivity and 97% specificity. The test uses mass spectrometry to detect specific volatile organic compounds in human breath samples.
 
Silver Factory Technology won provisional authorization for its TracieX Breathalyser shortly after the Breathonix approval. HSA cleared the Silver Factory test, which analyses human breath composition using Raman spectrometry, after reviewing the results of a clinical study that generated a sensitivity of 95% and a specificity of 97.8%.
 
HSA Notice
 

Pakistan proposes revising legislation on contract drug manufacturing

The Drug Regulatory Authority of Pakistan (DRAP) has published draft amendments to legislation on contract manufacturing that include requirements such as the formation of written quality agreements between contract manufacturing organizations (CMOs) and their clients.
 
Contract manufacturing is addressed in the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. DRAP is proposing to amend and expand the existing text, introducing a new definition of “contract manufacture” and revising a schedule that sets out the requirements for agreements between CMOs and their customers.
 
The updated schedule places greater emphasis on quality, mandating written quality agreements and the establishment of a quality management system that clearly states who is responsible for what and addresses the process for releasing each batch for sale or issuing a certificate of analysis.
 
DRAP has expanded sections detailing the requirements of both the CMO and the company that gives it a contract. The requirements on CMOs now state contract manufacturers cannot pass on any work to a third party without the written consent of the organization outsourcing the work. Other changes to the CMO requirements include paragraphs outlining the change control mechanism and the responsibility to maintain records of the production and analysis of the products they handle.
 
DRAP is seeking objections or suggestions related to the draft amendment.
 
DRAP Notification
 

TGA calls out ‘seriously’ concerning radio ads about COVID vaccines

TGA is “seriously concerned” about the broadcasting of misleading information that “provides an incorrect picture of the safety of COVID-19 vaccines” by some Australian radio stations.
 
The advert, which was paid for by Australian businessman and politician Clive Palmer, said “Australia has had one COVID-19 associated death in 2021 but the TGA reports that there’s been 210 deaths and over 24,000 adverse reactions after COVID vaccinations,” according to the Guardian. The adverts were reportedly running in “high rotation” on multiple radio stations in Queensland.
 
TGA responded by pointing out it only knows of one death from vaccine-related thrombosis with thrombocytopenia syndrome or any other related condition. The agency added that almost 3,000 people in Australia die each week “and therefore it is quite expected that there have been some deaths reported within days or a few weeks of vaccination.”
 
The adverts were pulled from the radio stations after TGA issued its warning, in which it said the misinformation posed “an unacceptable threat to the health of Australians” and said public figures have a responsibility to be factual. Australia is contending with rising vaccine hesitancy.  
 
TGA Notice, The Guardian