Guidelines on MedDRA Coding for Drug Marketing Authorization Holders

On 6 May 2022 the Chinese NMPA issued the MedDRA coding guidelines for the MAHs.

The purpose of this guideline is to guide the drug marketing authorization holders (hereinafter referred to as "holders") in China to use MedDRA coding-related medical terms in the work related to post-marketing adverse reaction reporting. Other reporting entities may refer to the ideas and suggestions provided in this guide.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /