Historically, the review and approval of a Chinese investigational new drug (IND) has taken a year or even longer to complete, and NDA approval for a new drug lagged western counties by four or five years. Recently the National Medical Products Administration announced changes to encourage pre-IND consultation and shortened the clinical trial approval process to 60 working days, opening up new opportunities to expedite development. Changes were also made to encourage NDA submissions more in parallel with submissions in other regions.
Join this webinar to learn how to plan your first IND application in China. We will:
- Help you understand the new 60-day review system
- Explain new ways to consult with Chinese regulatory authorities
Additionally, this talk will also:
- Cover China’s current thinking about accepting foreign data for the approval of new drugs
- Explain how to apply ICH E5 and ICH E17 to facilitate simultaneous registration of medicinal products in different geographic regions