National Pharmaceutical Regulatory Agency (NPRA) Malaysia issued an updated guidance document on the requirements of Conditional Registration of Pharmaceutical Products during Disaster, in July 2021.
The main objective of this guidance document is to provide expedited access to pharmaceutical products for treatment or prevention during disasters without compromising aspects of quality, safety and efficacy using a risk-based approach.
The updates are:
- Introduction to the “Recognition Procedure”, which is the acceptance of the regulatory decision of another regulator or other trusted institution
- Shorter timelines for products that have been conditionally approved or given emergency use authorization or listing by any DCA reference countries or WHO
More details can be found in the GUIDANCE AND REQUIREMENTS ON CONDITIONAL REGISTRATION OF PHARMACEUTICAL PRODUCTS DURING DISASTER, Rev 1 (July 2021): https://npra.gov.my/easyarticles/images/users/1047/Lampiran-A-Guidance-and-Requirements-on-Conditional-Registration-of-Pharmaceutical-Products-During-Disaster-July-202_20210713-04Julth_2.pdf