A government program introducing electronic package inserts, or e-labels, for medicines — selected in 2022 as one of the top 100 regulatory reform tasks for food and drugs — has effectively come to a standstill.
According to the Ministry of Food and Drug Safety and the pharmaceutical and biotech industry on the 20th, new product designations under the drug e-label pilot program, which the ministry launched in 2023, have been fully suspended since last year. The pilot began with 27 products from 10 companies in 2023 and expanded to a total of 109 products from 27 companies after 82 products from 23 companies were added in 2024. No new designations have been made since.
Dong-A ST (170900), Chong Kun Dang (185750) and Boryung (003850) took part in the first round of the pilot. The second round included Samsung Bioepis, Yuhan (000100), MSD Korea and Novartis Korea.
E-labels allow patients to check the latest approved information — including efficacy, dosage and adverse reactions — through a QR code printed on drug packaging. If a drugmaker produces 100,000 units of an injectable and a new adverse reaction is later identified, it would normally have to replace the inserts or repackage the existing products. With an e-label, it can update the electronic document online and deliver the latest safety information without opening the packaging. Previously, changes to a drug's approved information required reprinting or replacing paper inserts, a process that typically took one to three months.
Companies participating in the pilot reported cost savings and environmental benefits. In its 2026 sustainability report, Boryung disclosed that converting 39 products to e-labels last year cut annual paper use by about 5.04 million sheets, or roughly 9 tons, and reduced printing and material costs by about 130 million won ($94,000) (roughly $94,000). Yuhan adopted QR code-based electronic inserts for seven injectable products and calculated that the move cuts about 4.43 tons of paper waste a year.
The problem is that the expansion of the pilot has been fully suspended since last year, when the government began a three-year research project running through 2027 to improve how drug labeling information is managed. The ministry says it plans to use the research to assess the need for an integrated system and to draw up expansion plans, but no timetable for new designations has been set.
"E-labels are not only industrially useful in cutting material costs but also serve as digital healthcare infrastructure that protects patients' right to know and the safe use of medicines," an industry official said. "An administrative decision is needed to widen the scope, starting with prescription drugs used in hospitals that have already been verified." A ministry official said: "The research project covers the labeling system as a whole, which is why it is being carried out as a three-year continuing project. We plan to expand e-labels, but the details have not yet been finalized."