South Korea – Publishes partial amendment to standard on pharmaceutical equivalence test

Ministry of Food and Drug Safety, Republic of Korea intends to revise the following matters in Standard on Pharmaceutical Equivalence Test

1. The fed Study shall be performed and its report shall be submitted to inflect the dosage form property of the enteric-coated products.

2. To judge the equivalence of comparative dissolution, only similarity factor shall be adopted rather than both of mean dissolution ratio variance and similarity.

3. The level of changes and data to be submitted shall be determined to change manufacturing procedure and manufacturing site.

4. Exemption from bioequivalence study shall be expanded to reflect the establishment of ICH Guideline M9. 

Product Coverage: Pharmaceuticals, quasi-drug

HS Code: 30

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.