The year 2023 marked significant transformations in the medical and pharmaceutical sectors. Despite facing resistance from the medical community, President Yoon Suk Yeol's administration declared its intention to increase the number of medical school seats starting in 2025. Additionally, 2023 witnessed the opening of the digital therapeutics market. The initiation of telemedicine this year led to an ongoing conflict between the medical community, opposing such practices, and the Ministry of Welfare, advocating for them, expected to persist into 2024. In the pharmaceutical industry, numerous domestic companies ventured into the global market. Korea Biomedical Review has compiled the 10 most noteworthy healthcare developments in 2023. -- Ed.

In December of last year, regulators implemented the "one strike out" system that revokes certification for violations of GMP (good manufacturing practice), and its first case occurred last month.

This, coupled with some absurd cases of mislabeling, has brought the issue of quality control of domestic drugs to the forefront.

In November, the Ministry of Food and Drug Safety (MFDS) decided to revoke the GMP conformity decision for a large-scale formulation of an injectable solid drug by Hutecs Korea Pharmaceutical.

During an on-site inspection in July, MFDS found that the company had manufactured six products, including Recutin Tab, by arbitrarily increasing or decreasing additives in violation of the license while falsely stating in the manufacturing records that the license manufactured the products.

The ministry explained that it determined that the degree of violation was serious and the intentionality was multiple, so it decided to revoke the “GMP conformity decision.” Once the GMP revocation process is finalized, the company cannot manufacture and sell drugs. Following the ministry’s announcement, Hutecs Korea reportedly applied for a provisional injunction to suspend its execution.

In August, a bizarre incident occurred in which Celltrion's drug was placed in a container of Myungmoon Pharma's drug. Celltrionl's Astection Enteric Coated Tab 100mg (aspirin) was packaged in some of Myungmoon Pharm’s over-the-counter medicine, Myungmoon Aspirin Enteric Coated Tab (aspirin), and was recalled. Both products have the same main ingredient and content. Theragen Etex, the contract manufacturer of the two items in question, said it was a simple mix-up caused by an employee error.

In the same month, KORUS Pharm issued a recall of its antibiotic "KORUS Cefaclor Cap 250mg (KEFACCAP in the export name)" by attaching the label of a different packaging unit to the product.

In June, Hyundai Pharmaceutical was found to have distributed dementia drug Tamirine ER Tab 8 mg in a container of hypertension drug Hyundai Minoxidil Tab (Minoxidil). Hyundai Pharm said that the Tamirine ER Tab packaging was labeled with the Hyundai Minoxidil Tab and that only one bottle was mislabeled.