Reasons for Proposal
The current Act prescribes that where a person who has obtained marketing approval intends to market a drug continuously after the expiration of the period of validity of marketing approval or notification of the relevant drug, he/she shall obtain renewed marketing approval or file a renewed marketing notification, and where a person who has obtained marketing approval fails to manufacture or import a drug during the period of validity, the marketing approval or notification of such drug shall not be renewable.
While concerns are rising over the safety of drugs due to cases such as an antihypertensive drug containing carcinogens, etc., it has been pointed out that it is problematic that persons holding marketing approval manufacture or import drugs in the minimum quantity for the renewal of marketing approval or notification of the relevant drugs and do not sell and distribute them.
When renewing the marketing approval, etc. of drugs, the Act requires the evaluation of information on the relevant drugs such as cases of side effects, quality control, improvement measures, etc. collected during the period of validity to confirm their safety and efficacy. However, in the case of drugs that do not fall under this because they are not sold, submitting information on such drugs is not necessary for their renewal. In order to protect public health, it is necessary when renewing the marketing approval, etc. of a drug to check the actual status of post-marketing safety and quality control of the relevant drug and comprehensively review its safety and efficacy.
Hence, this Amendment aims to create a basis for providing people with safe and effective drugs by prohibiting the renewal of marketing approval or notification of a drug that failed to be manufactured or imported during the period of validity of marketing approval or notification of such drug (Article 31-5).
Major Provisions
Prohibit the renewal of marketing approval or notification of a drug that failed to be manufactured or imported during the period of validity of marketing approval or notification of such drug (Article 31-5)
