The MedDRA (Medical Dictionary for Regulatory Activities) terminology was launched in 1999.
To support the use of MedDRA, the M1 PtC WG updates with each MedDRA release the two Points to Consider (PtC) documents on MedDRA Term Selection and MedDRA Data Retrieval and Presentation, available in English and Japanese, as well as condensed versions available in all MedDRA languages.
Please refer to the MedDRA page and MedDRA website for information about MedDRA and the Points to Consider documents.
In addition, since 2017, the remit of the M1 PtC WG was extended to include the maintenance of a companion document to the PtC documents, available in English and Japanese, which provides more detailed guidance, examples, and Questions and Answers on topics of regulatory importance such as data quality, medication errors, and product quality issues.
