I'm curious about the pharmaceutical clinical trial procedure.

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Hello, I'm the CEO of a small to medium-sized company. I'm considering proceeding with an M&A with another company, and I'm wondering what the procedures are. Also, what are the pros and cons of going through an M&A? I'd appreciate a summary of the procedures and pros and cons of SME M&A.

pharmaceutical clinical trial

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作者: 김국일

Pharmaceutical clinical trials proceed through approval procedures from the Ministry of Food and Drug Safety and the Institutional Review Board (IRB), and the structure is such that whether to approve a new drug is decided through verification of safety and efficacy.

First, the clinical trial sponsor prepares a clinical trial protocol and applies for approval to the Ministry of Food and Drug Safety and the IRB within the implementing institution.

The two institutions carefully review the protocol and decide whether to approve.

Subsequently, the clinical trial sponsor requests the responsible investigator to conduct a pharmaceutical clinical trial to verify the safety and efficacy of the new drug candidate substance.

The responsible investigator sufficiently explains the purpose and procedures of the clinical trial to the subjects, then after obtaining consent, conducts the trial in a scientific and ethical manner according to the clinical trial protocol.

In addition, during the pharmaceutical clinical trial process, the Ministry of Food and Drug Safety can conduct field investigations of the clinical trial implementing institution, the clinical trial sponsor, and the responsible investigator, etc., and finally, by evaluating the safety and efficacy of the new drug candidate substance, decides whether to approve the new drug, and only approved drugs can be sold.