I am seeking legal advice regarding pharmaceutical licensing and approval.

Hello. You have inquired about the procedures related to pharmaceutical licensing and approval.

In Korea, testing must be conducted only after obtaining prior approval from the Ministry of Food and Drug Safety, beginning at the drug development stage.

This is strictly regulated under the Pharmaceutical Affairs Act and related subordinate notifications.

In addition, even if approval has been obtained from the U.S. FDA, an independent review procedure must be undergone again within Korea, and clinical trial data, quality data, and documents related to manufacturing and distribution are required.

The approval procedure generally consists of ▲prior consultation (including clinical and nonclinical plans), ▲application for product approval of the drug, ▲review and supplementation, and ▲completion of approval.

In particular, for a new drug, the review data required to ensure safety and efficacy tend to be demanding at the time of approval, including data on stability and efficacy, data on testing methods, data on the registration of the active pharmaceutical ingredient, data on the risk management plan, and data on the assessment of quality control standards.

Therefore, it is advisable to prepare for pharmaceutical licensing and approval with the assistance of a specialized attorney who is well versed in Korean statutes and procedures and who has experience in responding to matters involving pharmaceuticals and the Ministry of Food and Drug Safety.

Receiving legal advice on pharmaceutical licensing and approval from the early stages can be an effective step for the future of your company, and you may wish to seek the assistance of Daeryun, a law firm ranked ninth in Korea based on the '25 value-added tax filings with the National Tax Service.