Regulatory Focus™ > News Articles > 2021 > 2 > Asia-Pacific Roundup: TGA ends COVID exemptions for ventilators, PPE

Asia-Pacific Roundup: TGA ends COVID exemptions for ventilators, PPE

Posted 02 February 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA ends COVID exemptions for ventilators, PPE

Australia’s Therapeutic Goods Administration (TGA) has let the emergency measures imposed to help the supply of medical devices during the pandemic lapse. The change means products will need to be included in the Australian Register of Therapeutic Goods (ARTG) to be supplied in the country.
 
In March and April 2020, Australia responded to worries about the availability of personal protective equipment (PPE) and ventilators by enacting emergency exemptions. The ventilator exemption gave hospitals the option of sourcing equipment that was manufactured to certain minimum technical requirements but was not approved by TGA.
 
Similarly, the PPE exemption freed suppliers of masks and other protective equipment from certain rules, including those related to conformity assessments, provided they had a contract with an agency such as the Australian Government Department of Health. Both exemptions ended on 31 January.
 
With Australia currently averaging around six cases of COVID-19 a day, the situation in the country has stabilized to the extent that TGA has allowed the exemptions to lapse.
 
The change has implications for organizations that sourced equipment under the exemptions. TGA said hospitals with unapproved ventilators can continue to use them but are responsible for considering how and when to deploy the equipment. Those considerations should take the limitations of the ventilators into account. From now on, only ventilators in the ARTG can be supplied in Australia.
 
TGA Notice
 
Pakistan posts guidelines on responsible use of antimicrobials in humans
 
The Drug Regulatory Authority of Pakistan (DRAP) has published guidelines intended to reduce the inappropriate use of antimicrobials in humans. Pharmaceutical and diagnostic companies are among the stakeholders targeted in the guidelines.
 
DRAP wants the pharmaceutical industry to ensure marketing and promotional activities aimed at healthcare professionals in Pakistan comply “with the particulars listed in the summary of product characteristics” and encourages “the rational use of the medicinal product.” The agency also called on drugmakers to align financial incentives with the principles set out in the guidelines and to monitor for evidence of drug resistance and off-label use of their products.
 
The guidelines also target the diagnostic industry. DRAP wants the industry to address the need for point-of-care surveillance as well as surveillance and support studies into the use and cost-effectiveness of novel antimicrobial tests.
 
The guidelines also directly address the regulation of antimicrobials. DRAP is planning to limit the use of last-resort antimicrobials, ensure labels carry up-to-date information about resistance and “review, or establish, the legal provisions on over-the-counter and without prescription availability of antimicrobials.” Additional labeling to highlight the risk of causing resistance through the irrational use of antimicrobials is under consideration.
 
DRAP created the guidelines in response to the World Health Organization’s (WHO) 2015 global action plan on antimicrobial resistance. WHO called on all countries to establish national action plans aligned with its own global proposal and the standards and guidelines of intergovernmental bodies.
 
DRAP Guidelines
 
TGA fines Life Biotech $81,000 over alleged false and misleading information
 
TGA has fined Life Biotech AU$106,560 ($81,250) for alleged non-compliance with requests for information and face mask samples in relation to COVID-19. The agency has accused the Australian seller of products including KN95 respirators of “providing false and misleading information.”
 
A postmarket review of face masks by TGA found that Life Biotech failed to comply with a number of requests for information and samples. The Therapeutic Goods Act 1989 requires companies to respond within specified time frames. When Life Biotech responded to other requests, it allegedly provided “partial, late and misleading responses.”
 
Now, TGA has issued eight infringement notices related to Life Biotech’s alleged noncompliance with the reporting requirements. The multiple infringements resulted in one of the largest fines issued by TGA in relation to COVID-19.
 
The fines follow other questions about masks that claim compliance to KN95, a performance rating under a Chinese standard. Concerns that the masks may fail to provide consistent and adequate respiratory protection have led regulatory agencies including Health Canada and the US Food and Drug Administration to issue safety notices. 
 
TGA Notice
 
DRAP shares advice on CTD filings, creates regulatory support desk
 
DRAP has published advice on the use of Form 5F to apply for marketing authorization for a new or generic drug product. The publication comes months after DRAP shared guidance on the Common Technical Document (CTD)-based Form 5F.
 
In the new documents, DRAP answers common questions about the switch to the CTD format and discusses the creation of targeted regulatory support. The frequently asked question text explains that companies seeking marketing authorizations for new and generic drugs need to use Form 5F. Companies seeking to export drugs can use either Form 5F or Form 5D. Manufacturers of veterinary medicines cannot use Form 5F.
 
DRAP also clarifies how Drug Master Files (DMF) interact with CTD filings. Submission of a DMF is optional, DRAP explained, but details of the drug substance need to be shared in the relevant sections of Form 5F.
 
Manufacturers that need additional support can reach out to the recently created CTD Facilitation Desk. DRAP has established the desk and published documents including a pre-submission screening checklist to improve implementation of Form 5F. The flurry of activity follows the release of guidance intended to increase the consistency of submissions made to DRAP.
 
DRAP FAQ, More
 
China’s CDE issues update on breakthrough drug designation program
 
China’s Center for Drug Evaluation (CDE) has shared details of the progress of its breakthrough drug designation program. CDE has accepted 26 therapies onto the breakthrough channel since publishing details of the initiative in July.
 
The initiative, which is intended to accelerate access to new medicines and improve use of regulatory resources, attracted early applications from Legend Biotech, Takeda Pharmaceutical and Johnson & Johnson’s Chinese R&D arm Xian Janssen. Legend Biotech became the first company to have a drug accepted into the program less than one month after CDE posted the program’s details.
 
The rate at which CDE accepted drugs into the program accelerated later in 2020. Toward the end of the year, companies including CStone Pharmaceuticals and Bayer secured breakthrough designations for their candidates, driving the total number of products with the status up toward 30.
 
CDE Notice, More (both Chinese)
 
Other News:
 
TGA has shared details of Boxed Warnings now carried by products containing pregabalin and gabapentin. The additions warn both drugs pose a risk of misuse. The gabapentin warning also states it carries a risk of dependence. The risks can be life threatening. The addition of the warnings follows a TGA investigation into continuing reports of misuse, abuse and dependence. TGA Notice
 
China’s CDE has issued guidance on adaptive clinical trials. The guidance addresses the factors sponsors need to consider when evaluating the suitability of an adaptive design, before going on to discuss commonly used techniques such as group sequential design, sample size re-estimation and adaptive enrichment. CDE Guidance (Chinese)
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published the third edition of its Drug Registration Guidance Document. NPRA described the document as a major revision of the text it released in 2016.  NPRA Guidance

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