Pharmaceuticals, quasi-drug

Notification on Partial Amendment of 'Regulation for Pharmaceutical Approval, Notification and Reviews' (43 page(s), in Korean)

The Ministry of Food and Drug Safety, Republic of Korea intends to revise the following matters in Regulation for Pharmaceutical Approval, Notification and Reviews.

1.Reinforcement of change control including manufacturing procedure for prescription drug

2. Abolishment of mandatory regulation on submission of manufacturing and Free Sales Certificate for imported new drug.

3. New Establishment on Example of indications of precaution for use by specifying package unit for disposable ophthalmic solutions at less than 0.5ml

4. Abolishment of foreign national drug formularies-based system to strengthen scientific evidence-based safety and validity review system