Advanced biopharmaceutical products

Proposed amendments to the "Enforcement Rule of the Safety and Support of the Advanced Biopahrmaceutical Products"; (8 page(s), in Korean)

The Ministry of Food and Drug Safety of the Republic of Korea intends to amend the Enforcement Rule of the Safety and Support of the Advanced Biopharmaceutical Products to include the following:

- Establishment of fee standards for the application for approval of new drugs among advanced biopharmaceutical products

- Raising fees of customized technical documents review by the field of newly developed drugs in compliance with approval

- Establishment of standards for reducing fees of newly developed drugs