Korea Revises Quasi-drug Permit Regulation

New proposals on the legal revision of quasi-drug permits were raised by MFDS on 9 November specifically regarding the application and technical review of quasi-drugs. The drafted rectifications mainly focus on the review work of several ingredients’ safety and efficacy and are currently undergoing public consultation until 9 January 2016.

The substances include polyhexamethylene guanidine hydrochloride (PHMG), oligo (2-2-ethyoxy) ethoxyethylguanidim chloride (PGH), cetylpyridinum chloride (CPC) -- when concentration above 0.05%, and dipropylisocinchomeronate. Both PHMG and PGH have been newly regulated due to their association as risk factors in the development of lung disease if inhaled. For any other ingredients not covered within this scope and without confirmed results on safety and efficacy, relevant measures in line with existing testing methods in Korea should be undertaken.

Another focal point of the revision is new preservative usage regulations. Restriction on both Methylchloro-isothiazolinone and Methylisothia-zolinone are now being imposed, confining their application to the purpose of cleaning at a concentration not exceeding 0.0015%. Meanwhile, when used in production of quasi-drugs preservatives having been applied in cosmetic production under certain restriction must conform to relevant criteria set out in Korea’s pharmaceutical manufacturing standards which were not specified in the proposal and can be searched for using the official database created by MFDS.

With an aim to enhance screening of quasi-drugs before placement on the market, the proposal stressed that exemptions on the safety and review process are only available to products which are fully aligned with a string of specification, performance, efficacy, usage and dosage requirements. Companies should also submit relevant materials for safety and efficacy review of their products once there has been change to or cancellation of the category to which their products belong under the current “Korean Pharmaceutical Affair Law”.

The pharmaceutical affair law has undergone multiple changes in 2015, strengthening the application and review regulation as one of its major monitoring instruments towards quasi-drugs, which often demands companies to submit materials combining clinical testing and toxicological data. 

Reference: MFDS Official Website