Seoul, South Korea – The Ministry of Food and Drug Safety (MFDS) announced on [date] a significant overhaul of its drug approval and management system, effective from January 1, 2025.

Key changes include:

Accelerated New Drug Approval: The introduction of a new, streamlined process for approving innovative drugs. This involves:Dedicated teams for each drug application.
Increased face-to-face consultations between companies and reviewers (up to 10 times).
Expedited Good Manufacturing Practice (GMP) assessments within 90 days of application.
Revised Fee Structure: A new fee of 4.1 billion won will be implemented for new drug applications, effective from January 1, 2025.
Simplified Import Drug Registration: The process for registering imported drug substances (DMFs) has been simplified, reducing processing time from 120 days to 20 days.
Flexible GMP Assessments: For manufacturers with a history of compliance, the frequency of on-site GMP inspections may be reduced, allowing for more frequent remote assessments.
Extended GMP Certificate Validity: The validity period for GMP certificates has been adjusted, providing more flexibility for manufacturers.
"These new regulations aim to provide the public with safe and effective drugs more quickly, while also supporting the growth of the pharmaceutical industry," said an MFDS official.

The reforms are expected to:

Enhance efficiency: Streamlined processes and increased consultations will expedite drug approvals.
Improve transparency: Clearer guidelines and regular communication will increase transparency.
Reduce regulatory burden: Simplified procedures will reduce the administrative burden on manufacturers.
The MFDS plans to continue monitoring the implementation of these changes and make further adjustments as needed.