Regulatory Open Forum

Hello,

I can't find a source of information on the requirements of unique identifiers for drugs, in this case a capsule. The FDA is clear that drugs must contain a unique identifier, but I am wondering if there is a standard that would work for the EU and US, and what entities provide clear guidance here? Is there a clearing house or place where a pharma company can look up identifiers currently in use, thereby avoiding duplication? Is there a global standard to the creation of unique identifiers? Thank you for any guidance here.

Hello Anon

Not sure if you're looking for a list of capsule imprints or the NDC codes?

https://www.drugs.com/imprints.php

https://reference.medscape.com/pill-identifier

https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

There is not yet a global standard, although there is work toward that.

https://www.fda.gov/industry/fda-data-standards-advisory-board/identification-medicinal-products-idmp