NPRA Malaysia Issues Latest Drug Registration Guidance Document

National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued the latest updated version of the Drug Registration Guidance Document (DRGD) in January 2022. 

One of the main updates is regarding the updated pharmacovigilance guidelines whereby all the relevant references have been updated to “Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, August 2021”. 

Information on Anastrozole and Bortezomib has been included under the specific labelling requirements, as well as some amendments for insulin and mycophenolate. 

Other important updates have also been included and the list can be accessed via this link: https://www.npra.gov.my/easyarticles/images/users/1047/DRGD%20Jan%202022/Compilation-List-of-DRGD-Updates-Sept-2021-Jan-2022.pdf  


More details can be found in the main guidance document “Drug Registration Guidance Document (DRGD), 3rd edition, 2nd revision, January 2022”: https://www.npra.gov.my/easyarticles/images/users/1047/DRGD%20Jan%202022/Complete-Drug-Registration-Guidance-Document-DRGD-3rd-Edition-2nd-Revision-January-2022.pdf  

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