"Innovative New Drug Development Requires 4 Essential Documents... Easy If You Know the Principles and Direction"

Jongwon Kim, Director at MFDS
"Innovative Drug Development Is Like Baseball... Hope K-Bio Hits More Home Runs"

As domestic bio companies increase their development of innovative new drugs, a regulatory official advised that thorough preparation is necessary for clinical approval and product licensing of new drugs.

On the afternoon of the 10th, Kim Jong-won, head of the Vaccine Inspection Division at the Ministry of Food and Drug Safety, stated this during a lecture titled "Considerations of Regulatory Science in Innovative New Drug Development" at 'Bio Korea 2023' held at COEX in Gangnam-gu, Seoul.

Kim explained that in the new drug development process, four elements must all be prepared for clinical trial approval and product licensing: ▲Good Manufacturing Practice (GMP) ▲Chemistry, Manufacturing, and Controls (CMC) ▲non-clinical trial data ▲clinical trial data. He emphasized, "Even if you score 100 points in non-clinical trials, if GMP scores 59 points, approval will not be granted," adding, "Ultimately, developers must produce all four types of data within a limited timeframe."

He also compared clinical approval and product licensing in innovative new drug development to baseball. Just as a player scores by running through first, second, and third bases and returning home, clinical trials must be perfectly completed from Phase 1 to Phase 3 before product licensing can be obtained. Kim said, "In the end, returning home is the goal in baseball, and the same applies to new drug development," and explained, "To develop innovative new drugs, collaboration with many stakeholders from the early stages of clinical trials is necessary."

Regarding innovative new drugs without related guidelines, he explained that persuading regulatory authorities based on scientific validity and logic is sufficient. Kim stated, "When developing new innovative drugs, there are often no guidelines, but clinical approvals were still granted even when there were no guidelines for cell therapy products," and added, "The basic principle of persuading regulators with scientifically valid and well-reasoned data does not change."

He also advised that quality issues should be prioritized during the clinical process. He said, "Whether developing quickly or slowly, quality standards remain the same. What matters is how quickly the same data can be produced," and advised, "Developers should consider quality issues from Phase 1 clinical trials to become new drug developers who can hit a home run."

Finally, Kim emphasized, "Many find regulatory science difficult, but if you know the principles and direction, it can be approached easily," and reiterated, "The basic principle of persuading regulatory authorities with scientific validity and reasoning does not change."

This content was produced with the assistance of AI translation services.