Biological Products

Proposed amendments to the "Regulation on Approval and Review of Biological Products." (31 page(s), in Korean)

·         Whereas the products with the same strength of active ingredients, dosage form and route of administration for each unit dose are approved as one product, orphan drugs can be approved as separate products.

·         Domestic pharmaceutical companies may manufacture drugs using contract-manufacturing in overseas manufacturing facilities, which are established or whose shares are largely held by the domestic pharmaceutical companies. Importers of pharmaceuticals may also entrust part of the manufacturing process of import products to domestic manufacturers.

·         If pharmaceutical companies change strains of the approved influenza vaccines, the products should be reviewed in order to ensure safety and efficacy. The approved pharmaceuticals described as "in-house packaging units" or "manufacturer’s packaging units" did not indicate the specific packaging unit information under the current regulation. As a result, consumers couldn't check the dosage or the total number of drugs in circulation. Under the amended regulation, however, more detailed packaging unit information of approved drugs will be provided.

·         The amended regulation provides bases that can be used to subject orphan drugs to re-examination upon consent of the applicant company. 

Please refer to the attached document for information on other revisions to the Regulation.