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Regulatory Focus™ > News Articles > ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

Posted 15 May 2012 | By Alexander Gaffney, RAC 

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing.

"The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clarify and update, without compromising safety, the criteria for deciding whether the conduct of a two-year rodent carcinogenicity study of a given pharmaceutical would add value to this risk assessment," wrote ICH in a statement.

The EWG, S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals, said it hopes to develop a "crisply defined" plan detailing how the working group would impact the efforts of other groups working on carcinogenicity testing topics, including S1A: Need for Carcinogenicity Studies in Pharmaceuticals and S1B: Testing for Carcinogenicity of Pharmaceuticals.

The S1 EWG said in its concept paper that it sees a need to "help determine whether aspects of a pharmaceutical's pharmacology and toxicology, as current evaluated in nonclinical programs, can be used to adequately assess the degree of carcinogenic risk short of conduct two-year rodent bioassays."

The group expects to modify the existing ICH S1 rodent carcinogenicity testing Guidelines, but first must surmount a number of issues, including the need for additional data, the limits of analytical studies, process alignment between sponsors and regulatory authorities, clear definitions of endpoints and the use of secondary pharmacologic characteristics to predict outcomes.

Read more:

ICH - The Steering Committee endorses the establishment of an S1 EWG

ICH Safety Guidelines

Concept Paper - S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals

Business Plan - S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals


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