Korea Revises Quasi Drug Evaluation Requirements

Korea adjusted the existing evaluation requirements for quasi drugs to align with the new quasi drug reevaluation scheme implemented on December 4th 2015.

Enlarge the scope of high risk ingredients

MFDS newly adds polyhexamethylene guanidine hydrochloride (PHMG), oligo (2-2-ethyoxy) ethoxyethylguanidim chloride (PGH), cetylpyridinum chloride (CPC) -- when concentration above 0.05%, and dipropylisocinchomeronate into the scope of high risk ingredients which can potentially cause cellular damage. Both PHMG and PGH have been discovered as risk factors in the development of lung disease if inhaled. The preparations of inhalation, spray, steam or mask containing the two ingredients are considered to be in question. Any other ingredients without confirmed results on safety and efficacy are restricted for use.

Revise quasi drug usage restrictions

Methylchloro-isothiazolinone and Methylisothia-zolinone was regulated to be used under a concentration of 0.0015%, but now are only permitted to be used in rinse-off products. The MFDS also stipulated that bactericidal preservatives designated with a set restriction in cosmetics shall conform to the corresponding limits when used in quasi drugs.

Set rules on efficacy and safety evaluation documentation preparation

For categories of quasi drugs that already have a license, certain products which are fully aligned with a string of specifications including performance, efficacy, usage and dosage requirements can be exempt from the evaluation of efficacy and safety when applying for new category licensing. Companies shall submit documents for safety and efficacy review if their products belong to a category which has been cancelled after reevaluation by the MFDS.