Regulatory Focus™ > News Articles > 2020 > 7 > Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivi

Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

Posted 14 July 2020 | By Nick Paul Taylor 

Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.
Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by having “a large multidisciplinary review team” work around the clock. Five working days elapsed between the acceptance of the submission dossier and the registration decision.
That turnaround time reflects the support of TGA’s international peers. The European Medicines Agency (EMA) and the Singapore Health Sciences Authority (HSA) “generously shared” their review reports at an early stage, TGA said, thereby enabling the Australian agency to use their assessments to inform its decision. EMA and HSA are two of a small number of regulatory agencies to approve remdesivir before TGA.
The provisional approval clears Gilead to provide remdesivir in Australia for up to six years. Gilead can apply for full approval when it has the clinical data needed to confirm the safety and efficacy of the antiviral. The current data are limited but strong enough to persuade TGA that remdesivir should be part of the Australian response to COVID-19.
Describing remdesivir as “the most promising treatment option so far,” TGA sketched out hopes that the potential for the antiviral to shorten stays in hospital will reduce the strain COVID-19 is placing on the Australian healthcare system. The approval comes at a time when the virus is resurgent in parts of Australia. Having been well below 20 throughout most of May and June, the seven-day rolling average of new daily cases has shot up in recent weeks to almost 200.
TGA Notice, More
Philippine FDA foresees another year without foreign GMP inspections
The Philippine Food and Drug Administration (FDA) has suspended overseas good manufacturing practice (GMP) inspections until July 2021. FDA revealed the extension of the pandemic-related shift in its approach in guidelines on how it will handle requests from foreign drug manufacturers in the interim.
Last month, FDA released draft guidelines detailing how it would compensate for its inability to carry out the in-person assessments of GMP compliance that are normally central to the registration of foreign manufacturers. Having reviewed feedback on the June draft, FDA has revised and finalized its process for registering foreign manufacturers during the COVID-19 pandemic.
The updated guidelines firm up how long FDA expects the suspension of foreign inspections to last, dropping the phrase “until further notice” in favor of “a period of one year.” FDA has also revised the guidelines that will apply to manufacturers during that period.
In the revised version, FDA states the remote assessment service is open to “manufacturers which have been inspected by Pharmaceutical Inspection Cooperation Scheme, ASEAN Mutual Recognition Agreement and part of the WHO Prequalification Program.” The draft suggested the service would be open to any manufacturer that submitted the required paperwork and paid the associated fee.
FDA also clarified what happens to companies that are found to be compliant with GMPs based on a remote review. Such companies will receive an interim approval to proceed with registering a drug product. FDA will only issue a Foreign cGMP Clearance after conducting an on-site inspection.
Companies working on COVID-19 drugs and vaccines will be prioritized by the remote assessment team. Manufacturers of innovator drug products and companies that had already begun the filing process are next on FDA’s list of prioritized organizations.
Final Guidelines
Boehringer overturns NPPA ruling on retail price of Synjardy in India
Boehringer Ingelheim has won its appeal against the fixing of retail prices of products containing the active ingredients empagliflozin and metformin in India.
In March, India’s National Pharmaceutical Pricing Authority (NPPA) set the price of empagliflozin-metformin tablets made by Boehringer at between Rs 25.66 and Rs 32.45 ($0.34 and $0.43), depending on the dose. Boehringer hit back against the price ceiling, leading to deliberations at an NPPA meeting in May.
The Department of Pharmaceuticals (DoP) disclosed the outcome of the deliberations last week, revealing Boehringer had withdrawn its grievances after NPPA agreed the price cap is not applicable to its products. News of the shift in policy comes shortly after Boehringer disclosed a partnership with Cipla to co-market an empagliflozin-metformin formulation in India as Oboravo Met.
DoP Notice
Pandemic prompts TGA to post advice on thermal imaging systems
TGA has published advice for manufacturers of thermal imaging systems. The advice, which clarifies the regulatory status of thermal imaging systems, comes as COVID-19 drives an upswing in interest in the devices.
The ability for thermal imaging devices to use infrared radiation to measure body temperatures has suggested a role for the technology in the screening of people for infection with coronavirus. That idea, which moves thermal imaging systems toward the definition of medical device, has caught the attention of regulators in the UK and now Australia.
TGA said thermal imaging systems meet the definition of medical device when used in the screening of “potentially febrile individuals during a pandemic.” Systems with infrared radiation measurement capabilities are Class IIa devices and must be registered prior to importation and supply.
Companies can sell thermal imaging systems without getting them added to the Australian Register of Therapeutic Goods provided they make no claims about their use in the screening of potentially infected individuals. The technology can also be used in security systems. TGA may take compliance actions against manufacturers that promote security systems in diagnostic contexts.
TGA Notice
India’s NPPA asks manufacturers to provide 3.3M dexamethasone tablets
India’s NPPA has told manufacturers it will need 3.3 million dexamethasone tablets through the middle of August. The request for dexamethasone manufacturers to ensure they can meet India’s supply needs comes after a clinical trial linked the steroid to improved COVID-19 outcomes.
A clinical trial run in the UK found dexamethasone reduced mortality in ventilated COVID-19 patients. With the finding spurring global interest in the steroid, NPPA wants to ensure India has enough of the drug to manage its growing COVID-19 case load. India has averaged more than 25,000 new cases of COVID-19 a day over the past week.
In light of the situation, NPPA wrote to Zydus Cadila, which controls four-fifths of the Indian market for dexamethasone, and its main rivals Wockhardt and Cadila Pharmaceuticals, to ensure access to the steroid.
NPPA wants the companies to “take proactive steps to maintain adequate stock and ensure supply across the country” and make supplies available wherever shortages are reported. To gain insights into the situation, NPPA also asked the manufacturers to share details of production levels over the past two years and their anticipated output for the coming six months.
NPPA Notice
Other News:
TGA has said it issued fines of almost AU$1.8 million ($1.3 million) to people and companies alleged to have engaged in illegal activities in the past financial year. The figure was inflated by AU$549,000 in fines that TGA issued in relation to COVID-19 in the last few months of its financial year, which closed at the end of June. TGA Notice


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