KUALA LUMPUR – Covid-19 vaccines’ conditional registrations have been fast-tracked since December 14 as approval now only takes 120 working days, said the National Pharmaceutical Regulatory Agency (NPRA) amid accusations the surge in infections is due to a prolonged approval process.
It said that the risk-based approach has shortened the duration of complete vaccine approvals from 245 working days to 120, starting from the priority review approval until the conditional registration status was given.
In a statement today, the NPRA said the accusations were untrue because the Drug Control Authority (DCA) has fast-tracked the conditional registration for Covid-19 vaccines in the country since December 14.
It said this was done to address the urgency of the Covid-19 situation that was done through a priority review mechanism.
“This is intended to expedite the approval and give immediate access to Covid-19 vaccines in the country, without neglecting the quality aspects, safety, and efficacy using a risk-based approach.”
It added that NPRA’s standards and references in evaluating related vaccine dossiers are based on guidelines issued by international regulatory bodies.
The regulators include the World Health Organisation (WHO), European Medicines Agency (EMA), US Food and Drug Administration (FDA), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
“Completed and evaluated Covid-19 vaccine applications and dossiers will be immediately submitted to the DCA for approval of conditional registration,” said NPRA.
“The NPRA works closely with companies and manufacturers to ensure they promptly submit complete information for each application.”
It added that without complete data and information, the quality status, efficacy, and safety of Covid-19 vaccine could not be determined, and this prevented the DCA from giving conditional registration.
The NPRA said there were currently six vaccine products that have been evaluated and received conditional approval from the DCA in the time frame given, adding that it was also evaluating several new applications that would be expedited using the same methods.
“The NPRA has always been open to receiving views of various parties.
“Most importantly, the safety and well-being of Malaysians must come first in our journey through the Covid-19 pandemic by paying attention to the quality, effectiveness, and safety of the Covid-19 vaccine registered by the population in Malaysia.” – The Vibes, May 25, 2021
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