What Are The Requirements For Submitting Clinical Data In South Korea?

Submitting clinical data in South Korea requires adherence to guidelines set by the Ministry of Food and Drug Safety (MFDS). Data must demonstrate safety, efficacy, and quality, and be collected according to Good Clinical Practice (GCP) standards. Submissions include trial protocols, patient data, statistical analysis, and compliance with ethical and regulatory requirements.

Leave a Reply

You must be logged in to post a comment.