Pharmaceuticals

Proposed amendments to the "Regulations on Fees for Pharmaceutical Approvals, etc."; (10 page(s), in Korean)

The Proposed amendments to the "Regulations on Fees for Pharmaceutical Approvals, etc." are as follows:

A. Increase in fees for application of new drug approval and preliminary review (Annex 1,3,5 and 26 of the Draft)

- To expand the human resources with high quality and ability for approval review and facilitate rapid approval of new drug and give patients expeditious access to innovative health care by increasing fees for new drug approval and review.

B. Fee reduction of new drug for SMEs (Newly established Article 2(4) of the Draft)

- To support the domestic new drug development by discounting 50% of such fee for the drug developed and manufactured in Korea by small and medium-sized enterprises regardless of the increase in the fees for new drug approval and review.