I need legal advice regarding pharmaceutical approval.

Hello, you have inquired about the pharmaceutical approval procedures.

In Korea, you must receive prior approval from the Ministry of Food and Drug Safety from the drug development stage before conducting trials.

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

Also, even if you have received US FDA approval, you must go through an independent review procedure again in Korea, and clinical trial data, quality data, and manufacturing and distribution-related documents are required.

The approval procedure generally consists of ▲pre-consultation (including clinical/non-clinical plans) ▲pharmaceutical product approval application ▲review and supplementation ▲approval completion.

Particularly for new drug pharmaceuticals, the review materials for safety and efficacy, including data on stability and effectiveness, data on test methods, data on registration of raw material drugs, data on risk management plans, and data on quality control standard evaluation, tend to be quite stringent.

Therefore, it is good to prepare for pharmaceutical approval with the assistance of a specialist attorney who is familiar with Korean laws and procedures and has experience in dealing with the Ministry of Food and Drug Safety.

Receiving legal advice from the early stages is the fastest shortcut to pharmaceutical approval.