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.

• This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

Creator

• Ross, Susan Marie
• Rumpf, Nathan Frederick
• Wen, Yuan
• Michelini, Stephen Dominic

Subject

• Health
• Well-Being
• Industry
• Innovation
• Security

Publisher

• Worcester Polytechnic Institute

Identifier

• E-project-121415-221927

Keyword

• Medical care

Advisor

• Boucher-Yip, Esther
• Hou, Zhikun

Year

• 2015

Center

• Hangzhou, China Project Center - IQP

Sponsor

• Zhou, Xiaomai
• Hangzhou DOC Biotech

Date created

• 2015-12-14

Location

• Hangzhou

Resource type

• Interactive Qualifying Project

Rights statement

• In Copyright

Last modified

• 2022-04-01