EMA Adopts ICH Q&A on Nonclinical Evaluation for Cancer Drugs

Regulatory NewsRegulatory News | 16 May 2018 |  By 

The European Medicines Agency (EMA) on Wednesday adopted the International Conference on Harmonisation's (ICH) questions and answers guideline on the nonclinical evaluation of anticancer drugs.
The 17-page document includes 41 questions and answers offering additional clarity on ICH S9, including information on studies to support nonclinical evaluations such as toxicology studies and nonclinical data to support trial design and marketing.
The agency's Committee for Medicinal Products for Human Use (CHMP) adopted the ICH S9 Guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers document just weeks after its adoption by the ICH Assembly.
With its adoption by CHMP, EMA says the questions and answers document will take effect on 16 November 2018.
According to ICH, the document was needed as both regulators and industry have experienced challenges in interpreting and implementing the guideline since its adoption in 2009.
Some of issues addressed by the Q&A include whether additional toxicology studies in animals are needed for drugs that are shown to increase survival in patients (ICH says these are not usually warranted, but may be needed on a case-by-case basis) and what types of studies are necessary to support the clinical evaluation of drug combinations (ICH says a toxicological evaluation should be done for each individual drug and there should be a scientific rational to demonstrate increased anti-tumor activity of the combination).


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