Korea: New Drug Reclassification Bill Announced



The Korea Food and Drug Association (KFDA) recently revised the classification of six medicines. Two over-the-counter (OTC) drugs were re-categorized as prescription drugs, while two previously prescription drugs can now be sold at pharmacies OTC. Classifications of 11 other drugs which consumer groups had also asked the KFDA to review were not changed.

These changes are part of KFDA’s plan to review the classification of nearly 40,000 drugs by the end of 2011. A special task force of experts has been formed to complete the review by evaluating the scientific research and data of each drug.

The Ministry of Health and Welfare (MHW) has also announced plans to submit a new bill to the National Assembly. The bill would revise Korea’s Pharmaceutical Law by introducing a third category called “household drugs” which can be sold at supermarkets and convenience stores. The household drug category would include drugs currently sold OTC in pharmacies such as cold medication, fever reducers, and digestive drugs. MHW officials plan to introduce the bill to the National Assembly by the end of 2011.

The proposed bill revision comes as part of a broader initiative to increase consumer access to medicines. In July of 2011, the KFDA re-designated 44 non-prescription medicines — such as energy and digestive drinks — as non-drugs to expand their sale beyond pharmacies and into retail outlets.