‘Made In China’ Provision Removed From Green Channel Policy

10 Sep 2013

• By Varun Saxena

The original draft of an accelerated approval policy in China for innovative devices included a condition that a product being considered for the special pathway “is produced in China.” That condition has been removed from the latest draft following pressure from the U.S. government.

Under pressure from the U.S. government, Beijing removed regulatory language stating that innovative devices must be produced in China to be eligible for accelerated approval under what is known as the green channel policy.

The original draft, released in the spring, had four conditions for eligibility, including a requirement that the product being considered...