In order to provide an easy-to-understand explanation of the required documents and types of change management for quality and equivalence assessments associated with post-approval changes, we have prepared and published an English version of the 'Guidelines on Post Approval Change Management of Pha...

Guidance on Physicochemical Equivalence Test (Guidance for Industry)

Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products(Guidance for Industry)

Considerations on the Development of Personalized Neoantigen-Targeted Therapy Products(Guidance for Industry)

MFDS publishes a compilation of analytical methods to support drug manufacturers' efforts to control mutagenic impurities incuding nitrosamines.This document is intended to providepharmaceutical industry with the information about the analysis methods for the determination of mutagenicimpurities in ...

This document is intended to provide pharmaceutical industry with the information about the analysis methods for the determination of mutagenic impurities in drug substances or drug products. The analysis methods in this document were developed and validated in the research studies funded by MFDS. B...