Malaysia NPRA has release circular on Drug Registration Guidance Document (DRGD) guideline Updates on Variation application processing timeline for all registered products including all product categories and Introduce Reliance Mechanism for Pharmaceutical products.
Key Updates are as followings:
a) New processing timeline for MiV, MiV-PA, MaV and grouping/bundling variation applications
b) Implementation of reliance mechanism for pharmaceutical products including biological products that have been approved by at least one of DCA reference agency and
c) Supporting document requirements and application procedures through the QUEST system.
The circular related to this updates can be accessed at the following link:
https://npra.gov.my/easyarticles/images/users/1153/DCA/Direktif/2026/Pengemaskinian-DRGD-Berkaitan-Permohonan-Variasi-Produk-Berdaftar-Tempoh-Masa-Pemprosesan-bagi-Semua-Kategori-Produk-dan-Pengenalan-Mekanisme-Reliance-bagi-Produk-Farmaseutikal.pdf