ICH aims to slash number of drugs needing 2-year rodent carcinogenicity testing
This article was originally published in SRA
Executive Summary
The International Conference on Harmonisation has approved plans for developing a new guideline on rodent carcinogenicity testing of human drugs1. The document, when finalised and adopted, could result in fewer drugs requiring two-year rodent carcinogenicity studies in cases where other data is available to support patient safety.
You may also be interested in...
ICH Finalizes Guide To Cutting Down On Rat Carcinogenicity Studies
An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.