AI and big data to streamline South Korea’s drug evaluation processes
A new AI system under development will initially target synthetic drug evaluations, with broader applications expected in future phases.
The Ministry of Food and Drug Safety (MFDS) of South Korea is modernising its drug review and evaluation processes by incorporating AI, big data, and other emerging technologies.
The efforts are being spearheaded by the ministry’s National Institute for Food and Drug Safety Evaluation (NIFDS).
Starting next year, NIFDS plans to apply AI to assist with routine tasks such as preparing review data.
The initial focus will be synthetic chemical drugs, gradually expanding to other product categories.
‘Initial AI applications will focus on streamlining repetitive tasks,’ said Jeong Ji-won, head of the Pharmaceutical and Medical Device Research Department at NIFDS.
‘The AI system is being developed internally, and we are evaluating its potential for real-world inspection scenarios. A phased approach is necessary due to the large volume of data required,’ Jeong added.
In parallel, NIFDS is exploring using big data in various regulatory activities.
One initiative involves applying big data analytics to enhance risk assessments during overseas GMP inspections. ‘Standardisation remains a challenge due to varying formats across facilities,’ said Sohn Kyung-hoon, head of the Drug Research Division.
‘Nonetheless, we’re working to develop a system that enhances the efficiency of inspections without relying on foreign collaborations.’ Efforts also include building domain-specific Korean-English translation models for safety documentation.
The institute also integrates AI into pharmaceutical manufacturing oversight and develops public data utilisation frameworks. The efforts include systems for analysing adverse drug reaction reports and standardising data inputs.
NIFDS is actively researching new analysis methods and safety protocols regarding impurity control.
‘We’re prioritising research on impurities such as NDMA,’ Sohn noted. Simultaneous detection methods are being tailored for smaller manufacturers.
New categorisation techniques are also being developed to monitor previously untracked substances.
On the biologics front, NIFDS aims to finalise its mRNA vaccine evaluation technology by year-end.
The five-year project supports the national strategy for improving infectious disease preparedness in South Korea, including work on delivery mechanisms and material composition.
‘This initiative is part of our broader strategy to improve preparedness for future infectious disease outbreaks,’ said Lee Chul-hyun, head of the Biologics Research Division.
Evaluation protocols for antibody drugs are still in progress. However, indirect support is being provided through guidelines and benchmarking against international cases. Separately, the Herbal Medicine Research Division is upgrading its standardised product distribution model.
The current use-based system will shift to a field-based one next year, extending to pharmaceuticals, functional foods, and cosmetics sectors.
‘We’re refining the system to improve access and quality control,’ said Hwang Jin-hee, head of the division. Collaboration with regional research institutions remains a key component of this work.’
NIFDS currently offers 396 standardised herbal medicines. The institute continues to develop new reference materials annually as part of its evolving strategy.
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