The B3/C3 formats are introduced to facilitate regulatory submissions of WHODrug data.
The different WHODrug formats have information about the same drug names in WHODrug - but on different levels of specificity. Until March 1st 2017, the dictionaries of WHODrug have been available in the B2- and C-formats. In January 2016, the launch of the new, improved WHODrug-formats, B3 and C3, was made official. From March 1st 2019, the B3-format will replace the B2-format and the C3-format will replace the C-format. The first release of WHODrug with the new B3/C3 formats was March, 2017
To learn more about the differences between the B2/C and the B3/C3 formats, please download our document ‘WHODrug B3- and C3-formats Implementation Guide’.
The dictionaries of WHODrug have been around for thirty years and have constantly evolved to meet users’ needs and current standards. WHODrug is now required or strongly recommended by leading national authorities for the reporting of concomitant medications in clinical trials and in post-marketing safety surveillance. The B3/C3 formats are introduced to facilitate regulatory submissions of WHODrug data in formats meeting regulatory CDISC SDTM expectations, without the need of any workarounds. To learn more about how the WHODrug data fits into the CDISC SDTM standard, please download our document ‘How to use WHODrug for compliance with CM domain in the CDISC SDTM standard’.
Companies planning to submit study data during 2017 or later are recommended to use the B3/C3 formats to meet regulatory SDTM expectations.
The improved WHODrug-formats, B3 and C3, were officially launched in January 2016. Read more about the implementation timeline of the new improved B3 and C3 formats.
We want to assist you in your implementation of the B3/C3 formats. Read more about the UMC resources you can make use of.