Asia Regulatory Roundup: TGA begins virtual GMP inspections of domestic manufacturers

RoundupsRoundups | 28 April 2020 |  By 

Australia’s Therapeutic Goods Administration (TGA) has begun conducting virtual inspections as part of a new approach to oversight of domestic manufacturers during the COVID-19 pandemic.
The coronavirus continues to shape TGA operations even as Australia is starts to relax its lockdown. The plan for handling domestic good manufacturing practices (GMPs) inspections shared this week reflects an assumption that in-person assessments of drug production facilities are likely to be a challenge for some time.
With routine onsite inspections on hold, TGA is assessing both the need for inspection and the risk associated with not doing so in-person. Based on the assessment, TGA will take one of four options:
  • Perform a fully virtual assessment, using “agreed communication tools” and doing a desktop review of information to gauge the compliance of a site with GMPs;
  • Employ a hybrid approach that combines a desktop review with “an on-site inspection under agreed, controlled conditions;”
  • Perform a full on-site inspection “where it has been evaluated as necessary and safe to undertake;” or
  • Defer the inspection altogether “under specific conditions”.
The range of options is intended to enable TGA to “ensure continued governance” of GMPs at licensed sites, facilitate new GMP licenses and maintain public confidence in drugs made in Australia. The administration sought to balance those goals against the need to “minimize potential impacts from an on-site inspection on industry staff and department personnel by reducing the need for or duration of on-site inspections of domestic manufacturing sites where social distancing might be difficult to achieve.”
TGA will restart routine GMP inspections “at an appropriate time when the pandemic restrictions are lifted.” In the meantime, TGA’s onsite inspections will focus on sites linked to the response against COVID-19 and serious threats to public health.
TGA Statement
Australia’s pandemic pharmacy substitution powers may drive lasting changes
Substitution powers granted to Australian pharmacies to deal with shortages stemming from the pandemic may stay in place in some form over the longer term. TGA said it is “important to consider the feasibility” of pharmacy-level substitution given the “ongoing impact of medicines shortages.”
The Australian government currently allows pharmacists in some circumstances to dispense products of a different dose, form and release rate than those identified on the prescription. Pharmacists can exercise the powers, which apply to shortages with “a high likelihood of significant and immediate negative health consequences,” without prior approval from the prescriber.
The powers are intended to help supply chains cope during the pandemic. However, TGA has left the door open to the continued empowerment of pharmacists to substitute medicines during future shortages not related to the pandemic.
“With the ongoing impact of medicines shortages, it will be important to consider the feasibility of there being certain pharmacist substitution powers on an ongoing basis,” TGA wrote. “Over the coming months, the Commonwealth and states and territories will consider whether different, longer-term approaches for substitution are appropriate.”
The current powers fall short of enabling pharmacists to dispense products with a different active ingredient. That could change, though, with TGA stating the “government may need to consider this option in the future” if “COVID-related medicine shortages escalate seriously.”
TGA Notice, More
China’s CDE drafts guidance on use of imaging endpoints in cancer trials
China’s Center for Drug Evaluation (CDE) has published draft guidance on the use of imaging to assess the efficacy of anticancer drugs. CDE framed the guidance as a response to the need for new endpoints as the duration of survival for patients with some cancers increases.
Imaging of tumors provides researchers with a way to quickly gauge if a drug is efficacious. However, the lack of relevant technical requirements or industry standards in China raises the risk that results will be affected by differences in how images are captured and analyzed. A desire to reduce that risk led CDE to publish the draft guidance.
In the text, CDE discusses the standardization of imaging protocols, the qualification and training of operators, considerations for data locking and modification, and other matters that could affect the reliability of the findings of oncology clinical trials.
CDE is accepting feedback on the draft for one month.
CDE Notice (Chinese)
TGA issues fines of AU$65,520 over COVID-19 adverts, test importation
TGA has issued fines totalling AU$65,520 ($42,300) to individuals and companies accused of breaking the rules on advertising and importing products related to COVID-19.
Two organizations are set to pay three quarters of the total fines issued this week. TGA fined one of those organizations, Peter Evans Chef, AU$25,200 for claims made about a device online and during a Facebook live stream. A company website claims the device is “proven to restore strength, stamina, co-ordination and mental clarity.” TGA alleges the Facebook stream said the device could be used in relation to COVID-19.
TGA also fined CK Surgitech AU$25,200. In that case, TGA issued the fine over allegations that the company made “a false or misleading statement” in a filing to have a COVID-19 test included in the Australian Register of Therapeutic Goods. TGA also accused the company of importing tests without the required clearances.
Two other fines also relate to COVID-19 tests. TGA fined Labtest Direct AU$12,600 for advertising a COVID-19 test on Facebook. The agency also fined a woman AU$2,520 for allegedly importing test kits.
TGA’s fines are part of a wave of regulatory actions in the region. The agency also began a postmarket review of COVID-19 test kits. The New Zealand Medicines and Medical Devices Safety Authority banned the unauthorized “importation, manufacture, sale, supply and use of COVID-19 point of care test kits.”
Peter Evans, CK Surgitech, Labtest Direct, More
Malaysia’s MDA seeks feedback on medical gas registration requirements
Malaysia’s Medical Device Authority (MDA) is seeking feedback on draft guidance on requirements for registration of medical gas systems. MDA created the guideline to explain how the medical device regulations apply to gases used to treat and anesthetize patients. 
The guidance states manufacturers must determine the intended use of a device, classify it based on rules set out by MDA and gauge if the product is subject to different control procedures. Depending on the risk class the device falls into, the manufacturer will either need to assess the conformity of the product or proceed straight to the submission of a registration application.
Applicants can seek registration of their devices using MDA’s MeDC@St system. Successful applicants will receive a medical device registration certificate that features a unique number issued by MDA. The manufacturer must label its device with the registration number.
MDA is accepting feedback until 8 May.
MDA Guidance, More
Other News:
TGA has proposed down-scheduling low-dose cannabidiol. The proposal follows a review that found low doses of the drug may have clinical utility and can be used in the management of some conditions without the oversight of a medical practitioner. TGA Notice


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