KUALA LUMPUR, Dec 23 — It takes roughly three to four months to register a Covid-19 vaccine with the National Pharmaceutical Regulatory Agency (NPRA), said the Health Ministry.
Its director-general Tan Sri Dr Noor Hisham Abdullah said all pharmaceutical products must be registered with the Drug Control Authority (DCA) following a quality, safety and efficacy evaluation process by the 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.
Dr Noor Hisham said the registration of a vaccine by a manufacturer is voluntary, and it is up to the manufacturer to submit its dossier to the NPRA.
“The first scientific documents, such as the dossier for the registration of a Covid-19 vaccine, were received by NPRA on December 15 from one company thus far.
“A typical dossier contains details including but not limited to administrative information including the proper label, package insert and patient information leaflet.
“It also includes quality documents such as manufacturing processes, materials, specification and evidence of consistency, non-clinical and clinical documents, as well as the Risk Management Plan and Periodic Benefit-Risk Evaluation Report,” he said.
Dr Noor Hisham added these documents are needed for risk/ benefit assessment without compromising the quality, efficacy and the safety of the vaccine.
“The 90 to 120 working days is identified as a priority review within the NPRA to review all the documents and to make a recommendation to the DCA.
“However, in the interest of public emergency, the NPRA is committed to providing a comprehensive review that is well within the stipulated timeline or earlier, which also includes correspondence to the company,” he said.
The NPRA will follow all international guidance and guidelines, such as from WHO and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Asean Common Technical Dossier, which apply to Malaysia.
“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 the DCA and in compliance with prevailing acts and regulations of Malaysia,” Dr Noor Hisham said.