The National Pharmaceutical Regulatory Agency (NPRA) today denied that the slow pace of the vaccination rollout in the country was due to delays in approval for Covid-19 vaccines.
In a statement, it said it had in fact implemented a conditional fast-track registration route for Covid-19 vaccines since Dec 14 last year, through the Drug Control Authority (DCA).
It also said the evaluation period for complete registration applications had been shortened from 245 to 120 working days, starting from the date of approval for priority review applications and conditional registration status.
“This is to expedite approval and in turn provide immediate access to the use of Covid-19 vaccines in the country, without neglecting the aspects of quality, safety and efficacy using a risk-based approach,” it said.
NPRA also said it refers to standards provided by national regulatory authoritues from other countries including guidelines issued by the World Health Organization, European Medicines Agency, US Food and Drug Administration, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use to evaluate Covid-19 vaccines dossiers.
“NPRA works closely with companies and manufacturers to ensure they promptly submit complete information for each application.
“Indeed, without complete data and information, the quality status, efficacy and safety of a Covid-19 vaccine cannot be determined, which is why the conditional registration approval has not been given by the DCA,” it said today.
As of today, there are six Covid-19 vaccines products which have been fully evaluated by the NPRA within the stipulated time.
The vaccine manufacturers approved by the NDRA are Pfizer’s BioNTech Manufacturing GmbH and Pfizer Manufacturing Belgium NV, AstraZeneca’s Medimmune Pharma BV and AstraZeneca AB Sweden and PharmaNiaga’s Sinovac Life Sciences Co Ltd and PharmaNiaga Life Sciences Sdn Bhd.