Korean MFDS Publishes Data Collection on Dissolution Test Methods
Recommendation

Monday, 21 September 2026 14.00 - 16.00 h
Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
In December 2025, the Korean Ministry of Food and Drug Safety (MFDS) released the new Dissolution Test Method Data Collection. The publication is intended to support professionals involved in pharmaceutical research and development, quality control, manufacturing, education, and training by offering a user-oriented and practice-focused reference for dissolution testing.
The document is structured as follows:
- 1. Introduction
- 2. Application of Dissolution Test Method
- 3. Development and Validation of Dissolution Test Method
- 4. Domestic and Foreign Pharmacopoeia Status
- 5. Appendix
The appendix provides a dissolution test checklist intended to support the execution and documentation of dissolution testing.
The new document in Korean language can be found as a PDF file on the website of the Korean National Institute of Food and Drug Safety Evaluation.
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests


