(1) Reasons for Proposal

The Amendment aims to enhance fairness and professionalism in the re-evaluation of drugs, prescribes a systematic re-evaluation procedure, and otherwise aims to improve the drug re-evaluation system.

(2) Major Provisions

A. Clarify the scope of items excluded from re-evaluation (Article 2, paragraph 1, subparagraph 6)

1) Drug substances used only for the formulation of finished products or for preparations are not required to undergo a re-evaluation of safety and efficacy.

2) The Amendment clarifies the scope of items subject to re-evaluation, thereby aiming to improve work efficiency.

B. Improve the procedure for selecting items subject to re-evaluation and preparing proposals (Article 3, paragraph 5 and Article 6, paragraph 3)

1) Opinions are gathered from relevant organizations after preparing a re-evaluation proposal through a comprehensive assessment of data submitted for a drug re-evaluation.

2) The Amendment prescribes a procedure for making inquiries about the opinions of relevant organizations when selecting target items and preparing proposals to ensure first-hand opinions are incorporated from the early stages of the re-evaluation procedure.

C. Prescribe clinical trial-related procedures for submitting data for a re-evaluation (Article 5-2)

1) The relevant clinical trial procedures for the submission of re-evaluation data comply with “Korean Good Clinical Practice,” but this is not stated in the relevant regulations.

2) The Amendment specifies clinical trial procedures and requirements, thereby aiming to improve work efficiency and transparency.

D. Prescribe grounds for reliability investigations of data submitted for a re-evaluation (Article 5-3)

1) Reliability investigations of re-evaluation data are conducted in accordance with the “Bioequivalence Test Standards” and “Korean Good Clinical Practice,” but this is not stated in the relevant regulations.

2) The Amendment modifies the relevant regulations to prescribe reliability investigations of data submitted, thereby aiming to contribute to the supply of drugs whose safety and efficacy have been better assured.

E. Clarify re-evaluation assessment procedures (Article 6-2)

1) Requests for supplementation of data submitted for re-evaluation are made in accordance with the “Civil Petitions Treatment Act,” but this is not stated in the relevant regulations.

2) The Amendment clarifies supplementation requests and other procedures, thereby aiming to enhance work transparency and efficiency.