National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the third revised version of the guidance and requirements on conditional registration of pharmaceutical products during disaster in March 2022.
The objectives of this guidance are to speed up the process of bringing in new pharmaceutical products (including vaccines) during disasters, by using a risk-based approach, and to be used as a source of information for all stakeholders.
Applications that are submitted via this route and fulfil the requirements will be granted priority review, which has a timeline of 70 working days for processing.
The validity of a conditional registration is one year and can be renewed twice (validity of one year each time).
More details can be found in “Guidance and Requirements on Conditional Registration of Pharmaceutical Products during Disaster, 3rd revision, March 2022”: https://www.npra.gov.my/easyarticles/images/users/1047/Guidance-and-Requirements-on-Conditional-Registration-of-Pharmaceutical-Products-During-Disaster-March-2022.pdf