90 - 120 WORKING DAYS TIMELINE FOR COVID-19 VACCINE REGISTRATION WITH THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MOH MALAYSIA
All pharmaceutical products must be registered with the Drug Control Authority (DCA) following a quality, safety and efficacy evaluation process by the National Pharmaceutical Regulatory Agency (NPRA), MOH before it can be marketed in Malaysia. NPRA has been recognised by the World Health Organization (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.
The registration of a vaccine by a manufacturer is voluntary. It is up to the manufacturer's initiative to submit their dossier to NPRA. The first scientific documents (i.e., dossier) for the registration of a COVID-19 vaccine were received by NPRA on 15th December 2020 from one company thus far.
A typical dossier would contain information including but not limited to:
a. Administrative information (including proper labelling, package insert, patient information leaflet)
b. Quality documents (including manufacturing processes, materials, specification and evidence of consistency)
c. Non-clinical and clinical documents
d. Risk Management Plan and Periodic Benefit-Risk Evaluation Report
All these documents are needed for risk/ benefit assessment without compromising the quality, efficacy and the safety of the vaccine.
The 90-120 working days is identified as a priority review within NPRA to review all the documents and to make a recommendation to the Drug Control Authority (DCA). However, in the interest of public emergency, NPRA is committed to providing a comprehensive review that is well within the stipulated timeline or earlier, which also includes correspondence to the company.
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 (ICH) and the ASEAN Common Technical Dossier which applies to Malaysia. These steps are critical to substantiate the SAFETY, QUALITY & 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.
Rujuk : FB Ketua Pengarah Kesihatan KKM