KOR/1002
WTO/TBT
KR Corée du Sud
  • 30 - Produits pharmaceutiques
2021-12-31
2021-11-02

Pharmaceuticals

Notification on Partial Amendment of "Regulation for Herbal medicine Approval, Notification" (73 page(s), in Korean)

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

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

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

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