INHAND: International Harmonization of Nomenclature and Diagnostic Criteria
for Lesions - An Update - 2019
Global Executive Steering Committee: Charlotte M. Keenan,, John L. Vahle, Dawn G. Goodman, Emily Meseck, Ronald Herbert, Alys E. Bradley, Matthew Jacobsen, Christine Ruehl-Fehlert,Rupert Kellner, Thomas Nolte, Susanne Rittinghausen, Shim-mo Hayashi, Takanori Harada, Hijiri Iwata and Katsuhiko Yoshizawa

Background:
Harmonization of nomenclature and diagnostic criteria
in toxicologic pathology has been a goal ofpathologists working in the profession for many years.
Early initiatives were undertaken by the STP in theUnited States and by the RITA data base group(Registry of Industrial Toxicology Animal-data) inEurope. Their efforts resulted in a number ofinternationally recognized publications: SSNDC:
Guides for Toxicologic Pathology and the WHO/IARC
International Classification of Rodent Tumors. In 2005,
the STP and European Society of Toxicologic
Pathology (ESTP), in conjunction with RITA, developed
a collaborative process to review, update, andharmonize existing nomenclature documents anddatabases. In 2006, the British Society of ToxicologicPathology (BSTP) and the Japanese Society of
Toxicologic Pathology (JSTP) joined the initiative, sothat the project has become truly global.

Structure•5 non-rodent species working groups: dog, monkey,minipig, rabbit and fish
•New group formed to address terminology in nonrodent ocular toxicity studies•Each group is composed of expert toxicologic
pathologists from each of the participating societies
responsible for developing preferred nomenclatureand diagnostic criteria.

Completed Organ Systems:• Respiratory System (Toxicol Pathol. 37 (7 Suppl):5S-73S)• Hepatobiliary System (Toxicol Pathol. 38(7 Suppl): 5S-81S)• Urinary System (Toxicol Pathol. 40 (4 Suppl): 14S-86S)• CNS/PNS System (Toxicol Pathol. 40 (4 Suppl): 87S-157S)• Mammary, Zymbal’s, Preputial and Clitoral Glands(Toxicol Pathol. 40(6 Suppl): 7S-39S)

Objectives:•Produce publications for each rodent organ systemand select non-rodent species that provide astandardized nomenclature and differential diagnosis
for classifying microscopic lesions observed in toxicity
and carcinogenicity studies

New Mission:•Serve in advisory role for the FDA Standard for theExchange of Nonclinical Data (SEND) initiative.
FDA has indicated a preference to utilize
microscopic pathology terminology developed by
INHAND as these terms will be published in a peerreviewed journal.
•Two representatives from GESC sit on the SEND
Controlled Terminology Team to assist with mapping
INHAND terminology to SEND codelists of preferredterms and reviewing requests for new terms.

Structure•Global Executive Steering Committee (GESC) withrepresentation from major societies of toxicologicpathology•15 organ system working groups (OWG) defined byGESC• WG develop nomenclature primarily descriptive innature and denote findings which can be documented
from the review of routine histologic specimens.
• Incorporating diagnoses that imply a process thatcannot be determined from routine histologicspecimens (e.g. phospholipidosis) is not recommended.
• Upon completion of the draft nomenclature, GESC
conducts an initial review, followed by a period during
which all members of participating societies arerequested to review the proposed nomenclature.
• WG then finalizes the nomenclature based oncomments from the GESC and general membership.
• Published diagnoses may be extended or amended; achange control process is now available.
• An important feature of INHAND is the use of thegoRENI (global open Registry Nomenclature
Information System, www.goreni.org) as a web-based
platform to both review draft nomenclature and publish
final nomenclature. Originally developed by RITA,goRENI provides access to members of all STPs aswell as government regulators. The most current
version of nomenclature is available on goRENI.

• Male Reproductive (Toxicol Pathol. 40(6 Suppl): 40S-121S)• Soft Tissue (J Toxicol Pathol. 26 (3 Suppl): 1S-26S)• Integument (J Toxicol Pathol. 26 (3 Suppl): 27S-57S)• Female Reproductive (J Toxicol Pathol. 27 (3&4 Suppl): 1S–107S)• Digestive System (J Toxicol Pathol. 29 (1 Suppl): 1S–124S)• Recommendations from the Apoptosis/Necrosis Working
Group (Toxicol Pathol. 44(2), pp173-188)• Cardiovascular System (J Toxicol Pathol. 29 (3 Suppl): 1S–47S)• Skeletal System (J Toxicol Pathol. 29 (3 Suppl): 49S–103S)• Endocrine System (J Toxicol Pathol. 31 (3 Suppl): 1S–95S)• Special Senses (J Toxicol Pathol. 31 (3 Suppl): 97S–214S)In Progress:•Lymphoid and Hematopoietic System (ready for publication)•Non-rodent

Acknowledgements

Executive councils and members of the societies of toxicologic pathology who havesupported this effort with resources and contributions to development ofthe organ system manuscripts.