First Edition of the MedDRA Points to Consider Companion Document is Available

27 June 2018

On behalf of the ICH M1 Points to Consider (PtC) Working Group, the MSSO is pleased to announce the posting of the first edition of the MedDRA Points to Consider Companion Document on the Support Documentation page of the  MedDRA website. It is available in English and Japanese in Word and PDF versions.

The purpose of the Companion Document is to supplement the existing PtC documents by providing additional details, examples, and guidance on specific MedDRA-related topics of global regulatory importance. The first edition includes sections on data quality and on medication errors. The Companion Document is intended to be a “living” document and will be updated frequently based on users’ needs.

MedDRA users are invited to contact the MSSO Help Desk with any questions or comments about the Companion Document.