Asia-Pacific Roundup: TGA seeks feedback on request to lift ivermectin restrictions

RoundupsRoundups | 06 September 2022 | By

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on whether to allow off-label use of the antiparasitic drug ivermectin, following a request by an applicant who branded the current restrictions as “irrational, irresponsible, reckless, negligent and possibly criminal.”
 
TGA limited off-label prescribing of ivermectin to dermatologists, gastroenterologists, hepatologists and infectious diseases specialists in 2021 in response to an increase in prescriptions of the drug to treat or prevent COVID-19. Like regulators around the world, TGA found a lack of good evidence to support the use of ivermectin against COVID-19 and acted to stop its use in the setting.
 
Now, the restrictions imposed one year ago are up for review. TGA’s Advisory Committee on Medicines Scheduling is set to discuss the issue in November.
 
“[The restrictions pose] a serious threat to public safety and may have caused the unnecessary deaths of thousands of Australians by preventing general practitioners from effectively treating their patients,” the summary of the applicant’s request reads. “Ivermectin is a safe, cheap and effective medication that may prevent 44% of COVID-19 infections and may prevent serious illness and death caused by COVID-19 infections. Ivermectin is well tolerated at doses well beyond those that are typically prescribed for approved indications, which is at odds with the reasoning provided for the Appendix D entry.”
 
While the applicant argues that ivermectin is effective, citing an observational study of its use in a prevention program in a single Brazilian city, authorities in Australia and around the world have reached different conclusions. As TGA notes in its request for feedback, the World Health Organization, US National Institutes of Health and the European Medicines Agency advise against the use of ivermectin for COVID-19 outside of clinical trials. TGA is accepting feedback until 29 September.
 
The agency put out the call for feedback the day after sharing news of a regulatory reaction related to ivermectin. TGA has fined World Environmental Technologies AU$13,320 ($9,050) over the alleged unlawful importation of ivermectin.
 
TGA Consultation, More
 
PMDA posts English-language translation of guide to remote inspection procedure
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has translated its guide to the remote inspection procedure into English. The guide describes how organizations can prepare and share files for remote assessment by PMDA.
 
In 2020, Japan established procedures for document-based good clinical practice (GCP) inspections of applications for approval of drugs and regenerative medicine products, as well as the assessment of good postmarketing study practices. PMDA established a procedure to support remote inspections in November 2020, only to revise its approach in May following a legislative change.
 
The new translation describes the major changes to the notification on remote inspection. As of 1 July, PMDA has accepted documents uploaded to its Electronic Study Data Submission System, also known as the Gateway System. The new guide lists the system alongside the cloud system as a way for applicants to share documents with PMDA. Documents on physical electronic media are accepted in some cases.
 
Other changes include the addition of points to be considered for documentation prepared in a language other than Japanese or English. PMDA is asking applicants to submit the document after the title and section names have been translated into Japanese or English. If requested by inspectors, the applicant will need to translate specific documents.
 
At the main inspection, PMDA is asking applicants to employ an interpreter who can explain the contents of the documents. The agency is advising applicants to be careful when employing an interpreter because factors such as the time difference may affect the timing and duration of the main inspection. PMDA has also clarified points regarding the preparation of documentation and the cloud system and video conferencing system.
 
PMDA Guide
 
TGA fines radiopharmaceutical manufacturer over alleged GMP failings
 
TGA has fined the radiopharmaceutical manufacturer Cyclotek Queensland AU$93,240 ($63,200) for allegedly breaching conditions of its manufacturing license.
 
At a recent good manufacturing practice (GMP) inspection of the company, TGA “identified unacceptable manufacturing practices that presented a risk of unsafe products being supplied.” The alleged issues at Cyclotek Queensland, which makes radiopharmaceuticals used in positron emission tomography scans, led to seven infringement notices.
 
TGA issued the notices “due to the seriousness of the breaches and for not taking appropriate steps to investigate and address manufacturing failures.” However, because the notices relate to past breaches of GMPs, Cyclotek Queensland can continue manufacturing. The affected batches are no longer in supply and no adverse events related to the products were reported. No disruption to supply is expected.
 
The agency is now working with Cyclotek Queensland to develop and implement preventative measures to address the GMP failures.
 
TGA Notice
 
Malaysia’s MDA lists harmonized classifications of medical devices in ASEAN region
 
Malaysia’s Medical Device Authority (MDA) has published a list of risk classifications of medical devices, including in-vitro diagnostics (IVDs), that are harmonized across the Association of Southeast Asian Nations (ASEAN).
 
In 2020, Malaysia signed up to the ASEAN Medical Device Directive, an agreement that requires the publication of a classification of medical devices. The newly published list fulfills that requirement.
 
The 16-page document is comprised largely of an annex that breaks types of medical devices and IVDs up into categories, such as cardiovascular and dental devices, and assigns them to one of four risk categories, A, B, C or D. The list also features comments that add caveats to some of the classifications.
 
MDA also published a list for borderline products, defined as products that are difficult to distinguish from a medical device. The list provides the ASEAN decision on the status of borderline products such as micropipettes and disinfectants. A micropipette is a non-medical device unless the manufacturer states it is for IVD purposes, while the status of disinfectants depends on their mechanism of action.
 
MDA Guidance, More
 
In a first, all five Access Consortium members jointly assess new drug applications
 
TGA has worked with the other four members of the Access Consortium on the assessment of new active substances for the first time. The regulatory agencies collaborated on the review of Novartis’ leukemia drug Scemblix and Roche’s eye disease therapy Vabysmo.
 
The Access Consortium began the New Active-Substance Work-Sharing Initiative in 2018. Since then, the UK Medicines and Healthcare products Regulatory Agency has joined its peers from Australia, Canada, Singapore and Switzerland in the consortium. The reviews of Scemblix and Vabysmo marked the first times all five agencies worked together to review new drug submissions.
 
TGA approved Scemblix and Vabysmo in July and August, respectively. In both cases, the approvals took place after 170 to 180 working days of TGA evaluation. Each agency in the consortium independently decides whether to approve a drug but benefits from the work of its peers, thereby reducing duplicated effort.
 
TGA Notice
 
Other news:
 
The government has extended the tenure of the Drugs Controller General of India by three months. Venugopal Girdharilal Somani is now set to stay in the post until 15 November. Gazette Notification

 

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