[ad_1]
PETALING JAYA: The National Pharmaceutical Regulation Agency (NPRA) requires 90 to 120 business days to review documents and make recommendations to the Drug Control Authority (DCA) on the registration of Covid-19 vaccines, says the director general of Health So Sri Dr. Noor Hisham Abdullah.
Dr Noor Hisham said that all pharmaceuticals must be registered with DCA following NPRA quality, safety and efficacy evaluations before they can be marketed in Malaysia.
“The NPRA has been recognized by the World Health Organization (WHO) as a ‘WHO Collaborating Center for the Regulatory Control of Pharmaceutical Products’ since 1996.
“This recognition is an acknowledgment by the WHO for the NPRA’s contribution in the field of regulatory affairs,” it said in a statement on its Facebook page on Wednesday (December 23).
However, in the interests of public emergency, Dr. Noor Hisham (Photo) He said NPRA is committed to providing a comprehensive review that is on or before the deadline, 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 to submit their dossier to NPRA.
“The first scientific documents (that is, the dossier) for the registration of a Covid-19 vaccine were received by NPRA on December 15 from a company thus far,” he said.
A typical dossier, he said, contains information such as administrative information, quality documents, clinical and non-clinical documents, as well as risk management plans and periodic benefit-risk assessment reports.
“All these documents are necessary for the risk or benefit assessment without compromising the quality, efficacy and safety of the vaccine,” said Dr. Noor Hisham, adding that NPRA will follow all international guidelines and guidelines and the Dossier Asean common technician The steps are essential to corroborate the safety, quality and efficacy of any vaccine intended for use in the country.
“The final decision on the use of a vaccine will only be made after receiving DCA approval and in accordance with current Malaysian laws and regulations,” he said.
On Monday (December 21), Dr. Noor Hisham said it will take up to four months for the NPRA to evaluate data from clinical trials provided by pharmaceutical giant Pfizer on the Covid-19 vaccine it has developed.
Dr Noor Hisham acknowledged that NPRA had received a formal request from Pfizer on December 15 to register its Covid-19 vaccine in Malaysia, adding that official commitments to Pfizer are expected in the coming days.
[ad_2]
