Faculty Advisor

Boucher, Esther F.

Faculty Advisor

Hou, Zhikun

Center

Hangzhou, China

Abstract

The goal of this project, sponsored by Hangzhou DAC Biotech, was to conduct a comparative analysis of the drug approval process for three agencies, with a focus on antibody drug conjugates (ADCs). The results show that the FDA has the fastest approval, the EMA has the safest approval, and the CFDA has the least expensive approval. This report concludes with an evaluation of each of the three agencies approval processes and recommendations for small biotech and pharmaceutical companies seeking approval for newly developed drugs such as antibody drug conjugates.

Publisher

Worcester Polytechnic Institute

Date Accepted

December 2015

Project Type

Interactive Qualifying Project

Accessibility

Unrestricted

Advisor Department

Humanities and Arts

Advisor Department

Mechanical Engineering

Project Center

Hangzhou, China

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