While it is required to obtain marketing approval from the Minister of Food and Drug Safety or file a marketing notification to manufacture, sell, or import drugs, the criteria of documentation for such approval and notification are defined in administrative rules. Hence, it is necessary to specify such criteria in law to ensure legal stability in drug approval management and transparency in policies.

Accordingly, this Act aims to define approval filing requirements for new drugs or drugs designated by the Minister of Food and Drug Safety and clarify approval requirements for drugs, which are filed based on new drugs’ safety and efficacy data when their active ingredients, contents, and route of administration are identical, by requiring the submission of bioequivalence test data.

Furthermore, as the current administrative rule allows bioequivalence test data to be shared unlimitedly, it is concerning that too many drugs share bioequivalence test data and it may lead to illegal distribution including rebates and weaken pharmaceuticals’ R&D capabilities. As such, this Act aims to limit to three the number of drugs that can be filed for approval by using the same bioequivalence test data in an effort to resolve confusion in distribution due to contract manufacturing and weakening capabilities in product development and reinforce competitiveness in the pharmaceutical industry, in the event that approval is sought by contract-manufacturing the drug to the manufacturing business office, which already manufactures the drug whose bioequivalence has been demonstrated, with the same manufacturing method and using the drug’s bioequivalence test data (Articles 31 and 42).

Limit to three the number of drugs that can be filed for approval by using the same bioequivalence test data in the event that approval is sought by using the drug’s bioequivalence test data (Articles 31 and 42).