The current Act requires an importer to register the name and location of the overseas production facilities with the Minister of Food and Drug Safety to import drugs, etc., prescribed by Ordinance of the Prime Minister. However, for the import of drug substances, safety management is not systematically conducted due to insufficient registration provisions. 

In addition, biological medicines, etc., need to obtain lot release approval from the Minister of Food and Drug Safety after the data on manufacturing and quality control of the drugs is examined and inspected, but recently, cases of individuals or entities obtaining national lot release approval by submitting false data have been found; therefore, it is being pointed out that there is a need to strengthen the sanctions.

Accordingly, this amendment aims to reinforce the management of overseas production facilities by requiring them to be registered even in the case of importing drug substances and strengthen the sanctions against those responsible persons or entities when national lot release approval is obtained through false or fraudulent methods (Article 42 (7), Article 76 (1) 5-10, and Article 93 (1) 9).

This amendment aims to reinforce the management of overseas production facilities by requiring them to be registered even in the case of importing drug substances and strengthen the sanctions against those responsible persons or entities when national lot release approval is obtained through false or fraudulent methods (Article 42 (7), Article 76 (1) 5-10, and Article 93 (1) 9).