EVERY drug and vaccine products have to be screened using the standard operating procedure (SOP) specified under the Control of Drugs and Cosmetics Regulations (CDCR) 1984.
“Every product must be vetted using the legislation for pharmaceutical product registration. The process is very strict and the Drug Control Authority (DCA) will make the final decision.
“There is also a procedure for emergency use of products like in any national regulatory body in the UK, the US Food and Drug Administration (USFDA) and European Medicines Agency (EMA),” Malaysian Pharmacists Society (MPS) president Amrahi Buang told FocusM.
Yesterday, Health Ministry director-general Tan Sri Dr Noor Hisham Abdullah said that Pfizer’s application to register its vaccine for use in Malaysia was received by the National Pharmaceutical Regulatory Agency (NPRA) on Dec 15.
He added that process will undergo five phases which may take between 90 and 120 days before approval.
“We have five phases. We may take around 90-120 days to scrutinise everything and make sure it is safe to use. That is the first phase.
“The second is to make sure we can procure these vaccines and have the logistics to handle it. The third step is prioritise certain groups such as frontliners and vulnerable groups.
“The fourth stage involves checking the after-effects of the vaccine, and the final step is to assess its effectiveness in curbing the spread of COVID-19,” business portal The Edge reported Noor Hisham saying.
As it is, Amrahi said the Government was already trying its best to speed up the approval process which usually takes years.
“We were told it will take about three to four months-time due to the emergency situation. Usually, the process takes between one and two years,” he noted.
Amrahi added that for the Pfizer Biontech vaccine, the National Pharmaceutical Regulatory Agency (NPRA) had already received its dossier and the latter would conduct its due diligence.
“And the same process will be applied to other COVID-19 vaccines from Moderna, Oxford -AstraZeneca and other Chinese companies.
“Make no mistake about it. There are no short cuts to the process and we must respect DCA’s decision on the matter,” he stressed.
In an update, the Health Ministry’s Pharmaceutical Regulatory Division director Dr Hasenah Ali had issued a directive to review the vaccine’s approval process, under the conditional fast-track procedure.
In a circular issued on Dec 14, she said that the CDCR had agreed to the fast-track registration procedure as the nation is going through a crisis (pandemic).
“Under this emergency process, all applications for pharmaceutical products, for use during a crisis, will be given the priority review status automatically and to be processed within 120 working days from the day we receive the full application.
“The products that receive approval under the fast-track procedure is valid for a year, starting from the day of registration.
“The said product can be re-registered twice in a year, under certain conditions,” she said. – Dec 22, 2020.
