KR South Korea
  • 30 - Pharmaceutical products


Proposed amendments to the "Korean Pharmacopoeia"; (88 page(s), in Korean)

The revision aims to provide reasonable support for proper pharmaceutical quality management by harmonizing standards and specifications in The Korean Pharmacopoeia with global standards and specifications. Moreover, the revision includes adding to the licorice origin species a species which the standard conformity with the existing species and the possibility of domestic cultivation were verified to lay the foundation for the localization of licorice.

In addition, to advance standards and specifications and distribute high-quality medicines by improving some of the general information that incorporated the development of advanced biopharmaceuticals and the demands of the pharmaceutical industry in line with the latest scientific level.

A. Addition of verified species to the origin of Licorice and incorporation of properties to the added species (Annex 4 of the draft)
B. Addition of flow cytometry, enzyme-linked immunosorbent assay (ELISA), and immunoblot analysis to general information (Annex 6 of the draft)