Approval for vaccines already fast-tracked, says NPRA

Approval for vaccines already fast-tracked, says NPRA

The National Pharmaceutical Regulatory Agency denies claims it was slow to approve vaccines for use here.

Sinovac, Pfizer-BioNTech and AstraZeneca are three of the six Covid-19 vaccines approved by the NPRA.
PETALING JAYA:
The National Pharmaceutical Regulatory Agency (NPRA) has addressed complaints that the government was slow to approve vaccines for use here, saying conditional approvals had already been fast-tracked since December last year.

The NPRA said it had been using a priority review registration mechanism since Dec 14 to ensure that the country may gain quick access to vaccines without sacrificing safety and quality.

It said that, as a result, the evaluation period for registrations had been shortened by half, from 245 working days to 120 working days.

“The NPRA’s reference and standards in evaluating Covid-19 vaccine dossiers are based on guidelines issued by the National Regulatory Authority of other countries, including the World Health Organization, European Medicines Agency and others.

“The NPRA works closely with companies and manufacturers to ensure they can immediately furnish the complete information for each application.

“This good communication and cooperation helped to successfully expedite the approval for vaccines in Malaysia,” it said in a statement today.

So far, the NPRA has approved six Covid-19 vaccine products from different manufacturers.

These include the Pfizer-BioNTech vaccine, produced by Pfizer Manufacturing in Belgium and BioNTech Manufacturing in Germany, as well as the AstraZeneca vaccine, produced by the AstraZeneca factory in Sweden and Medimmune Pharma in the Netherlands.

Meanwhile, the Sinovac vaccines are produced by the Sinovac Life Sciences facility in China and by Pharmaniaga under the fill-and-finish process in Malaysia.

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