Regulatory Focus™ > News Articles > 2022 > 1 > Asia-Pacific Roundup: TGA seeks feedback on adverse event data

Posted 25 January 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA seeks feedback on adverse event data

3136 Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into how to improve access to medicine adverse event data. The agency is proposing to enable sponsors to view and export such data from its systems.
Currently, sponsors cannot automatically view or export de-identified adverse event data held in TGA systems; instead, they must manually search the public Database of Adverse Event Notifications - Medicines or email TGA. After receiving a request, TGA manually exports the relevant data to a PDF document. As TGA sees it, those methods are inefficient for it and for sponsors and result in delays in access to important safety information.
TGA wants to allow sponsors to use its existing authentication processes to view and export de-identified medicine adverse event data. Before pushing ahead with the update, TGA wants to get feedback on specific aspects of the proposal.
The agency is seeking responses to 18 questions but singled out three broad areas of focus for the public consultation. TGA wants to know what medicine adverse event data sponsors want to view, the preferred formats for extracted data, and whether sponsors can switch to the International Conference on Harmonisation (ICH) Enterprise to Business (E2B) R3 standard.
One section of the survey is dedicated to the proposed transition to ICH E2B(R3). Many sponsors use the standard voluntarily when submitting Individual Safety Case Reports (ICSRs) to TGA. The data model used by TGA is based on the standard. Other regulatory agencies, including those in the US, EU and Japan, have already adopted E2B(R3) as their standard submission format.
TGA is asking sponsors whether they already use ICH E2B(R3) to file ICSRs with overseas regulators and how long they would need to transition to the format for their Australian submissions. The question features suggested transition time frames ranging from six months to four years.
TGA is accepting feedback until 18 February.
TGA Notice
India extends deadline for medical device manufacturers to apply for ISO certificates
The Indian government has given medical device manufacturers more time to apply for International Organization for Standardization (ISO) certificates covering their quality management systems.
In October, the government released draft amendments to the Medical Devices Rules, 2017, that would have required manufacturers to file for ISO 13485 certificates by 30 November 2021. Manufacturers that filed by then would have until 31 May 2022 to obtain the certificate. The latest update extends the deadlin for filing while retaining the deadline for obtaining the certificate.
Manufacturers now have until 28 February to file for ISO 13485 certificates. Manufacturers that meet the revised deadline for filing will get a provisional registration number that will remain valid until 31 May. Indian authorities will cancel the provisional registrations of manufacturers that fail to obtain ISO certificates by 31 May “without any notice.”
ISO 13485 sets out the requirements for quality management systems “where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.” India specified requirements for quality management systems in the Medical Devices Rules, 2017.
The government published the revised timeline on the same day as it released draft rules on the suspension and cancellation of medical device licenses. The draft rule will empower the Central Licensing Authority to cancel or suspend a license “for such period as it thinks fit” if the manufacturer or licensee fails to comply with any of its conditions. The authority must give the manufacturer or licensee a chance to show why it should not cancel or suspend the license. If a license is canceled or suspended, the affected company has 30 days to appeal the ruling.
Government Notification, More
TGA grants provisional approval to Pfizer, Merck oral COVID antivirals
TGA has granted provisional approval to oral COVID-19 antivirals from Merck and Pfizer. The actions clear Australia to start using the 800,000 courses of the two medicines that the country has ordered this year.
Merck and Pfizer have generated clinical data that suggests the use of their antivirals in the early days of infection with SARS-CoV-2 reduces the risk of hospitalization of death. The companies have already used the data to bring the products to market in the US and UK.
TGA authorized both drugs for use within five days of the start of symptoms in people who do not need oxygen and who are at increased risk of progression to hospitalization or death. Both products are given orally twice a day for five days. Neither Lagevrio nor Paxlovid is recommended for use in pregnancy and breastfeeding. Use of Paxlovid also is contraindicated in patients receiving certain other drugs because of the potential for side effects and reduced antiviral efficacy.  
TGA Notice
India to require APIs to carry QR codes next year
The Indian government is set to make manufacturers and importers of active pharmaceutical ingredients (APIs) put Quick Response (QR) codes on the label at each level of their packaging starting January 2023.
In an amendment to the labeling section of the Drugs Rules, 1945, the government has set out its plans to mandate the use of QR codes on all API packaging from January 2023 onward. The publication comes more than two years after the release of draft rules on the requirement.
The only change to the 2019 draft is the inclusion of January 2023 as the start date for the requirement. The government still expects the QR codes to store data on at least 11 pieces of information, including the unique product identification code, the name of the API and manufacturer, the expiry date and details of any special storage conditions.  
Government Notification
Other news:
TGA has provisionally approved Novavax’s COVID-19 vaccine Nuvaxovid. The authorization covers the use of Nuvaxovid for primary vaccination in adults, limiting its use to the fraction of Australians who are yet to receive another vaccine against COVID-19. Nuvaxovid is the first protein COVID-19 vaccine to receive regulatory approval in Australia. TGA Notice


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