New Drug Applications

The top two pharmaceutical markets in the world are the United States and China. Due to the difference between the two countries in regulations and policies, as well as the changing drug application system, many companies face challenges in the new drug application process. Are your trials meeting international standards? Is it possible to use data obtained in one country for a drug application submission in a different country?

This module mainly provides a thorough analysis of the strategy for the application in both China and the United States, covering the application process, pathway selection, and approval factors. Since clinical trial data is crucial for the application both in China and the United States, overseas clinical trial data acceptance has always been one of the focuses in the application process. This module will elaborate on the acceptability of clinical trial data based on practical cases, and help avoid common pitfalls in gaining access to international markets.

Workshop Outline

• Understand the process, trend and key points for drug application in China and the United States
• Learn the similarities and differences between China and the United States in expediting drug applications, and to find out the optimal application pathway
• Case Study: overseas clinical trial data acceptance in both China and the United States and its strategies