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South Korea proposed standard on pharmaceutical equivalence study


South Korea proposed standard on pharmaceutical equivalence study

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is issuing the proposed amendments to the regulation notified as MFDS Notice "Standard on Pharmaceutical Equivalence Study". The content of the amendments is as follows.

  1. In an aim to enhance the credibility for the quality of generic drugs, the acceptance criteria of bioequivalence study have been adjusted upwards to the level of advanced countries. Also, the standards on the selection of reference products in case of approval for change have been strengthened.
  2. Pharmaceutical equivalence study shall only be conducted with referenced products published by MFDS. In addition, the exemption criteria have been modified for bioequivalence tests between products that have been proved to be bioequivalent to its originals and the products that are also bioequivalent but have different strength with them.

Products covered: Pharmaceuticals

HS Codes: 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.


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