The Health Ministry has introduced new rules that will fast-track the conditional approval of Covid-19 vaccines that have already been approved through the World Health Organisation (WHO) emergency-use listing process.
The rules will also apply to vaccines approved by “stringent” drug regulators abroad that are used as a reference by Malaysia’s Drug Control Authority (DCA).
These are the National Pharmaceutical Regulatory Agency (NPRA) and DCA’s counterparts in the UK, Sweden, France, the United States, Australia, Canada, Japan and Switzerland as well as the European Medicines Agency.
“The directive comes into effect immediately from the date the directive is issued,” read a letter by the Health Ministry's Pharmaceutical Services director Norhaliza A Halim.
The letter is dated yesterday and was posted on NPRA’s website this morning. It was addressed to several Health Ministry department and division directors including the NPRA.
Assessment reports to be submitted
Under previous guidelines issued on Dec 14 last year, the NPRA prioritised the review of Covid-19 vaccines with the aim of completing the process within 120 working days from the date it receives a complete application to register the vaccine in Malaysia.
The revised guidelines introduce a new “recognition pathway” for conditional approval of vaccines already approved by recognised regulators.
The guidelines said this would “significantly shorten” the time taken for the review process but do not say by how much.
“The recognition procedure will expedite the product registration process without neglecting quality, safety and efficacy of the product by taking advantage of evaluation done by the WHO or stringent authorities,” read the directive by Norhaliza.
Those seeking conditional approval through the recognition pathway will have to submit all assessment reports by the WHO or the relevant drug regulator. This includes all questions and answers between the WHO or regulator and the vaccine manufacturer.
Fast-track for Moderna, Sinopharm?
For the record, the WHO has approved six Covid-19 vaccines for emergency use listing so far. Of these, only two have yet to be approved in Malaysia.
It is previously reported that Zuellig Pharma was seeking NPRA approval to market the Moderna vaccine in Malaysia. It is expected to go to the private market since the government is not procuring the vaccine for the National Covid-19 Immunisation Program (NIP) due to its high cost.
Kanger International Bhd, meanwhile, is seeking to import the Sinopharm vaccine for the Malaysian market.
On May 27, The Edge reported that the company had signed a memorandum of understanding to supply the vaccine to the Sabah government subject to approvals by the NPRA and DCA.
The NPRA is also considering applications to register the Sputnik V and Cansino Biologics vaccines, both of which would be part of the NIP if approved. Neither of these vaccines has been approved by the WHO or the regulators recognised by the DCA. - Mkini
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