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. 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’.
In October 2017, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register, in which they state that the use of the B3-format of WHODrug Global is supported and will be required in submissions for studies starting after March 15, 2019. Furthermore, the U.S. FDA Data Standards Catalog has also been updated with this information.
Both the B3- and C3-formats are compliant with regulatory requirements.
The data required for study data submissions, per the requirement described above, can be retrieved from both the C3-format just as from the B3-format. Therefore, C3-format users can easily also comply with the FDA requirement, just as B3-format users can. For more details, please read our document ‘WHODrug B3- and C3-formats Implementation Guide’.
As a general recommendation from UMC, companies planning to submit study data (to the U.S. FDA or other regulatory agencies) are recommended to make use the B3/C3 formats as soon as possible, to meet regulatory SDTM expectations and benefit from the improvements of the new formats.