-
-
-
Human Resources
-
What is the role of an IND in the biopharmaceutical industry?
Category:
Press Release
Release date:
2025-11-06
IND It is a core concept—it serves as the link between medications Preclinical research And Human clinical trials Of the Key Legal and Regulatory Bridges 。
IND Its full name is Investigational New Drug , commonly translated into Chinese as "New Drug Clinical Trial Application" 。
Simply put, IND's core purpose is to apply for and obtain approval from regulatory agencies—such as the U.S. FDA—to begin research on investigational new drugs in humans.
What does IND do? — Its dual role
The role of IND can be understood on two levels:
1. For regulatory agencies (such as the U.S. FDA):
It is a complete one. Data packet , whose core mission is Prove three things ：
Sufficient security: Based on preclinical data from animal studies, the drug has demonstrated a relatively reasonable safety profile in humans, with risks that are controllable.
Scientifically sound and reasonable: The drug demonstrated potential therapeutic activity against the target disease in animal models, and its mechanism of action supports further testing in humans.
Research Protocol Compliance: The planned human clinical trial (clinical protocol) is scientifically sound and ethically compliant, ensuring robust protection of the participants' rights, safety, and well-being.
2. For pharmaceutical companies or R&D institutions:
It is The "green light" to launch clinical trials Without IND approval, any clinical study conducted in humans intended to support drug marketing is illegal.
Keywords:
More information
Contact Us
You might also like to inquire
Changchun YunSci Biopharmaceutical Co. Ltd
Telephone：0431-80528606
Email：YCHT@yunsci.com
Website：www.yunsci.com
Address：No. 845 Shengde Avenue, Beihu Science and Technology Development Zone, Changchun City
Links:
Copyright: Changchun YunSci Biopharmaceutical Co. Ltd