PETALING JAYA: The National Pharmaceutical Regulatory Agency (NPRA) requires 90 to 120 working days to review documents and make recommendations to the Drug Control Authority (DCA) on the registration of Covid-19 vaccines, says Health director-general Tan Sri Dr Noor Hisham Abdullah.
Dr Noor Hisham said all pharmaceutical products must be registered with the DCA following quality, safety and efficacy evaluations by NPRA before they can be marketed in Malaysia.
"NPRA has been recognised by the World Health Organisation (WHO) as a 'WHO Collaborating Centre for Regulatory Control of Pharmaceuticals' since 1996.
"This recognition is an acknowledgement from WHO for NPRA's contribution in the field of regulatory affairs," he said in a statement on his Facebook page on Wednesday (Dec 23).
However, in the interest of public emergency, Dr Noor Hisham (pic) said NPRA is committed to provide a comprehensive review that is well within the stipulated timeline or earlier, which also includes correspondence with the company.
Dr Noor Hisham noted that registration of a vaccine by a manufacturer is voluntary, adding that It is up to the manufacturer's initiative to submit their dossier to NPRA.
"The first scientific documents (ie. dossier) for the registration of a Covid-19 vaccine was received by NPRA on Dec 15 from one company thus far," he said.
A typical dossier, he said, contains information such as administrative information, quality documents, non-clinical and clinical documents, as well as risk management plans and periodic benefit-risk evaluation reports.
"All these documents are needed for risk or benefit assessment without compromising the quality, efficacy and the safety of the vaccine," said Dr Noor Hisham, who added NPRA will follow all international guidance and guidelines, and the Asean Common Technical Dossier, as these steps are critical to substantiate the safety, quality and efficacy of any vaccine intended for use in the country.
"The final decision on the usage of a vaccine will only be made after receiving approval from DCA and in compliance with prevailing acts and regulations of Malaysia," he said.
On Monday (Dec 21), Dr Noor Hisham said it will take up to four months for NPRA to evaluate the clinical trial data provided by pharmaceutical giant Pfizer on the Covid-19 vaccine it has developed.
Dr Noor Hisham acknowledged that NPRA had received a formal application from Pfizer on Dec 15 to have its Covid-19 vaccine registered in Malaysia, adding that the official engagements with Pfizer are expected over the next few days.