Asia-Pacific Summary: TGA Releases COVID Vaccine Safety Oversight Plan

Australia’s Therapeutic Goods Administration (TGA) has released a five-point plan detailing the enhanced measures it will put in place to ensure the timely identification and mitigation of safety concerns during the deployment of COVID-19 vaccines.

The agency aims to “strengthen the existing vaccine vigilance system for the early detection and investigation of suspected side effects”, thereby enabling it to manage emerging safety issues and maintain public confidence.

Specifically, TGA is implementing an improved adverse event reporting process to ensure timely collection and management of reports; forms will be customized for each vaccine and will be shared between its staff and regional managers.

The agency is also looking to improve the detection and investigation of safety signals by ensuring it has the ability to conduct timely reviews of adverse event reports and the ability to collaborate in real time with AusVaxSafety, the national vaccine safety system. Upon identification of a safety issue, TGA will “use available legislation to implement effective and timely regulatory action” that can help address or reduce the emerging risk.

TGA will also ensure that information reaches consumers, healthcare professionals and sponsors quickly and will proactively monitor media reports to proactively identify public concerns regarding vaccine safety.

To achieve these goals, TGA plans to work with Australian officials and experts on consolidating ‘timely information sharing, communication and collaboration with national stakeholders on COVID-19 vaccine safety », As well as with officials abroad.

The plan’s release follows interim approval from Comirnaty (Pfizer / BioNTech) and the start of a national immunization strategy that initially targets around 700,000 people, including quarantine and border workers as well as residents. and staff in care facilities for the elderly and disabled.

Monitoring plan

Indian state calls on national government to suspend supply of COVID vaccine

The Indian state of Chhattisgarh has asked the national government to stop sending shipments of Covaxin, the COVID-19 vaccine made by Bharat Biotech, amid concerns over the lack of late-phase data on the vaccine.

India cleared Covaxin, a locally developed vaccine, for restricted emergency use earlier this year. The action drew immediate criticism from groups such as the All India Drug Action Network, which said they were “shocked” and “bewildered” by the decision to allow the use of the vaccine before Bharat completed the development of phase 3.

TS Singh Deo, Minister of Health in the Chhattisgarh government, called for the shutdown due to “community concern” about the vaccine and “a sense of hesitation about its use” due to lack of data complete phase 3 on its use. He also noted that the Covaxin vials did not have an expiration date.

Indian Health Minister Harsh Vardhan took a different point of view, taking to Twitter to ask if “is it really appropriate for a state health minister … to stir up inhibitions about” the effectiveness of a COVID-19 vaccine. Vardhan added that “in these unprecedented times” Singh Deo should help address any vaccine hesitation and “do what is in the best interests of the people, not other special interests.”

Vardhan expressed the same concerns in a formal response to his state-level counterpart. In the letter, Vardhan said the vaccine “is safe and immunogenic,” adding that Singh Deo’s concern about the lack of an expiration date is “completely unfounded” as the information is included on the vial labels.

Chhattisgarh Letter, Government response, Reuters

Pakistan allows private imports of COVID vaccines, exempts vaccines from price controls

Pakistan’s Medicines Regulatory Authority (DRAP) allows private companies to import COVID-19 vaccines into the country and exempts imports from price controls.

Under the policy, COVID-19 vaccines will be exempt from price caps for six months or until “market prices for these vaccines are available.” The exemption applies to vaccines registered for emergency use authorization and imported for sale in hospitals and institutions. Vaccines cannot be “sold or distributed in the market” if they are to qualify for the exemption.

The changes come as Pakistan, home to 220 million people, seeks to protect its people in the absence of major supply agreements. Pakistan’s vaccination campaign began after China donated 500,000 doses of Sinopharm’s vaccine, but will not expand significantly until it begins receiving millions of doses under the COVAX initiative and by agreement with CanSino Biologics.

DRAP notice, Reuters, Following

Indian NPPA to Stop Accepting Hard Copies of Retail Pricing Form

India’s National Pharmaceutical Pricing Authority (NPPA) is expected to stop accepting physical copies of a form related to retail pricing of new drugs as of April 1.

The change applies to Form I that companies use to request prices for new drugs. Historically, companies have sent hard copies of the form to the NPPA. However, last year, the NPPA made plans to streamline its processes, in part by moving to a fully digital Form I submission system.

The NPPA highlighted the faster turnaround times that have resulted from the move to online submissions for new drugs to justify the change and explain the benefits that can come from the new way of working.

NPPA Notice

Other news:

DRAP has asked manufacturers of products containing gluten or lactose to add allergen warnings on their labels. The patient information leaflet and the primary or secondary packaging should state that the product contains gluten or lactose to guide patients with allergies to the substances. DRAP took action after hearing about patients with celiac disease. DRAP notice

The Malaysian National Drug Regulatory Agency (NPRA) issued a circular on documentary reviews of good manufacturing practices among foreign pharmaceutical manufacturers. The release of the text comes as the NPRA seeks to maintain aspects of its inspection program despite travel restrictions linked to the COVID-19 pandemic. ONPR opinion (Malaysia)

An Indian regulatory committee said convalescent plasma showed no statistically significant difference in clinical outcomes compared to the control intervention in a phase 2 clinical trial. SEC Notice

© 2021 Society of Regulatory Affairs Professionals.

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