Health products policy and standards
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Nomenclature for Cell Therapy Substances

More than 50 years ago, WHO established the International Nonproprietary Name (INN) Expert Group / WHO Expert Committee on Specifications for Pharmaceutical Preparations, to assign nonproprietary names to medicinal substances, so that each substance would be recognized globally by a unique name. These INNs do not give proprietary rights, unlike a trade mark, and can be used freely as they are public property.

INNs have been assigned to biological products since the early days of the INN Programme. Since the time when insulin human became the first recommended INN (rINN) for a recombinant product, the range of biological / biotechnological products has increased in size and complexity.

In October 2015, a systematic scheme for naming cell therapy products has been recommended. Please see the document below.

 

INN Nomenclature Schema Icon

Mandatory information for INN selection and publication for cell-based therapies including cell-based gene therapy substances.(Please note that incomplete...

INN Bio Review
11 December 2023

INN Bio Review 2022

This document, first published on the website of the INN Programme in 2006, therefore presents an inventory of the policy decisions taken by the INN Expert...

Background documents

INN Nomenclature Schema Icon

During the 61th INN Consultation in 2015, a USAN-INN-harmonized nomenclaturescheme for cell therapy products (CTP) (shown in Table here below) was formallyfinalized...

INN Meeting Report

The INN programme has received many enquiries from developers of cell therapy productsand there is a pressing need to consider the establishment of a naming...

Icons INN Executive Summary

During the Consultation, a total of 132 INNs were discussed, including:107 new INN requests, including 47 for biological substances23 outstanding requests2...

Icons INN Executive Summary

During the Consultation, a total of 91 INNs were discussed, including: 70 new INN requests, including 31 for biological substances 17 outstanding...

Icons INN Executive Summary

During the Consultation, a total of 112 INNs were discussed, including:83 new INN requests, including 30 for biological substances25 outstanding requests4...