MFDS Establishes Regulatory Support System for Biopharmaceuticals Applying Exosomes
The Ministry of Food and Drug Safety (MFDS) recently announced on the 30th that it will proactively establish a regulatory support system, including product classification, in consideration of the increasing trend of next-generation biopharmaceutical development using new technologies such as exosomes.
To this end, the MFDS has enacted and implemented the regulatory guideline titled 'Regulations on the Classification and Productization Support of Next-Generation Biopharmaceuticals' starting from today.
The guideline includes ▲ definitions and product classification of next-generation biopharmaceuticals ▲ the composition and functions of the Next-Generation Biopharmaceutical Support Council and the internal review committee ▲ procedures for handling applications regarding whether a product qualifies as a next-generation biopharmaceutical and its classification.
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The MFDS expects that the enactment of this guideline will assist domestic developers in developing next-generation biopharmaceuticals and stated that it will continue to support the rapid productization of biopharmaceuticals based on regulatory expertise.
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