What Is The Process For Submitting A New Drug Application (NDA) To The MFDS?

The process for submitting a New Drug Application (NDA) to the MFDS involves preparing a comprehensive dossier that includes clinical trial data, safety and efficacy information, and manufacturing details. Applicants must submit the NDA electronically, after which the MFDS conducts a thorough review, engages in consultations, and ultimately decides on approval or rejection.

Leave a Reply

You must be logged in to post a comment.