"No Cold Medicine" "No Laxatives"... Preventing These Issues with Predictive Models

Pharmacy [Image source=Yonhap News]

"The supply of children's antipyretic analgesics in the acetaminophen category has somewhat improved, but the shortage of pseudoephedrine preparations that relieve nasal congestion symptoms remains. Not only cold medicine but also joint medicine and laxatives are difficult to obtain, leading to situations where pharmacies plead with other pharmacies or wholesalers." (Pharmacist A, Jung-gu, Seoul)

Following the 'cold medicine crisis' that began last fall, supply shortages of some medicines have continued recently, causing ongoing supply imbalances. The government is now preparing an artificial intelligence (AI) prediction model to address this issue. Until now, the government has held public-private consultative bodies involving pharmaceutical companies whenever there were supply disruptions of specific medicines, but there were limitations in responding when multiple types of medicines were out of stock simultaneously. On the 21st, the Ministry of Food and Drug Safety (MFDS) announced the 'Food and Drug Regulatory Innovation 2.0 Project' and stated that it will develop an AI-based prediction model to ensure stable supply of medicines.

Currently, even essential medicines for children are frequently out of stock at frontline pharmacies. According to a recent survey by the Korean Association of Children's Hospitals targeting 44 children's hospitals, 141 essential medicines including pediatric asthma treatments, antibiotics, and flu treatments are experiencing supply disruptions. Accordingly, the MFDS plans to analyze data on medicines that have had past supply issues to derive factors (evaluation variables) that can predict supply shortages. Kim Myung-ho, head of the MFDS Big Data Analysis Team, said, "Indicators such as medicine ingredients, import volume, distribution volume, and usage will be considered," adding, "The pilot project is scheduled to begin in March next year." The MFDS also plans to soon establish measures to ensure that increased production by pharmaceutical companies is evenly distributed to pharmacies.

The regulatory innovation project by the MFDS also includes provisions to prioritize the review of nationally essential medicines that are not yet approved domestically. If unapproved nationally essential medicines are included in the priority review category, approval reviews will be conducted within 90 days, reducing pharmaceutical companies' costs and shortening supply times.

Medicines manufactured using new methods are also expected to enter the market more quickly. According to the MFDS, the minimum period for stability testing (long-term storage testing) when changing manufacturing methods is currently six months, which is stricter than overseas standards. Going forward, the MFDS plans to refer to the World Health Organization (WHO) standard of three months to increase pharmaceutical companies' production performance.

The recognition of alternative testing methods that can reduce animal testing will also be expanded. Recently, the MFDS registered a testing method that can replace horseshoe crab blood used in vaccine development in the Korean Pharmacopoeia. Regulations for submitting data using alternative testing methods during clinical trials and product approval processes will be established.

Meanwhile, the MFDS also announced plans to expand the scope of licensing for food service businesses (restaurants) to include yachts and boats, and to allow the purchase of portioned block cheese at department stores and marts. These measures aim to enhance convenience for consumers and small business owners and to revitalize related industries.

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