a Amanda




I am looking specifically for version 2016-09-08, although it does seem like there might be more missing versions from the drop down list. Is this something that we can manually configure on our end?

Forums: Troubleshooting and Problems

on January 27, 2020

Hi Amanda, 

Could you explain why 2016-10-03 version can not work for your case?

NDF-RT dictionary have ~10 releases per year. So, we limited number of published versions for better usability. We thought that it's not an issue.

Thank you, 


a Amanda
on January 28, 2020

Hi Sergiy,


A client specifically requested that we validate with that version. Is it possible for it to be added?




on January 29, 2020

Hi Amanda, 

We can provide you 2016-09-08 NDF-RT file per your request. However, I think that a problem is not related to version of the dictionary.

According to FDA Technical Conformance Guide, Pharmacologic Class for FDA submissions should be based on "the established pharmacologic class" which "is generally the MOA, PA, or CS term that is considered the most scientifically valid and clinically meaningful. Sponsors should include in TS the established pharmacologic class of all active moieties [49] of investigational products used in a study. FDA maintains a list of established pharmacologic classes of approved moieties. If the established pharmacologic class is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. For unapproved investigational active moieties where the pharmacologic class is unknown, the PCLAS record may not be available.

[49] Available at http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM346147.zip"

Based on FDA request in ~2014, original NDF-RT files were filtered for [PE], [MoA], [EPC] and [TC] terms. Later, for MED-RT dictionary (which is actually the same as older NDF-RT) a list of these classes was extended by adding [Chemical/Ingredient].

So, my assumption is that you have a term from  [Chemical/Ingredient] class.

Kind Regards,


w Weijie
on July 21, 2022

Hi, Sergiy

So, the term     Vaccine [APC] N0000193912 MED-RT     which is APC and excluded from the NDF-RT 2021-11-01 txt, should not be used for PCLAS TS parameter. is that correct?

Thank you!

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