Korea to Revise Manufacturing Standards for Quasi-Drug

Recently the Korean MFDS released a notice on the revision of the manufacturing standards for quasi-drug. The main contents of this upcoming revision are:

1. Revising the manufacturing standards of hair dye:

1)        To reduce the upper concentration limit of 12 components including p-aminophenol. The new upper concentration limit for α-naphthol will also be set.

2)        The standards of hair dye are set to be aligned with international standards   

2. Setting manufacturing standards for teeth whitening products:

1)        To standardize the types of active ingredients, products specification, contents and prescription for teeth whitening products.

2)        To simplify the application procedures for teeth whitening products and facilitate market access.

3. Removing the components of hair dye which are not applicable to quasi-drug:

11 components including nitro-p-phenylenediamine and hydrochloride are to be removed.