Korean MFDS Releases New Dissolution Test Method Reference

In December 2025, the Korean Ministry of Food and Drug Safety (MFDS) published a new Dissolution Test Method Data Collection to support professionals working across pharmaceutical research and development, quality control, manufacturing, education and training. The guidance is designed as a practical, user-focused resource to improve understanding and application of dissolution testing.

The document is organised into five sections: an introduction, application of dissolution test methods, development and validation of dissolution tests, and an overview of domestic and international pharmacopoeial standards, followed by an appendix.

The appendix includes a structured dissolution testing checklist aimed at assisting laboratories with proper execution, consistency and documentation of dissolution studies.

This new reference, published in the Korean language, is available as a PDF on the website of the Korean National Institute of Food and Drug Safety Evaluation. The MFDS said the document is intended to strengthen regulatory alignment and technical competence in dissolution testing practices.

09-01-2026