Announcement on the Matters related to filing and Joint Review & Approval of Active Pharmaceutical Ingredients, Pharmaceutical Excipients, and Pharmaceutical Packaging Materials for Drug Products

The CNDA (formerly CFDA) has issued an announcement which clarifies the expectations for when excipient suppliers, API suppliers and packing suppliers can be exempted from the filing requirements for the China DMF (as listed in Announcement No. 146 30NOV17). This document provides exemptions, in certain cases, for compendial excipients, materials used in certain approved products in global markets, and for certain items such as pH adjusters, flavors and colors.

Click Here to View Official Publication

CFDA 2017 No. 146

Download Resource