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Regulatory Focus™ > News Articles > 2019 > 6 > FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

Posted 26 June 2019 | By Michael Mezher 

FDA Consults on ICH Safety Data, Bioanalytical Method Validation Guidelines

The US Food and Drug Administration (FDA) on Wednesday issued two draft International Council for Harmonisation (ICH) guidelines covering safety data collection and bioanalytical method validation for public consultation.
The consultation on the guidelines, which correspond to ICH's E19 Optimisation of Safety Data Collection and M10 Bioanalytical Method Validation, will be open for two months. Both guidelines reached Step 3 of the ICH process earlier this year and will undergo consultations by each ICH member before being adopted by the harmonization body.
According to ICH, regulators in Brazil, Europe, Japan and Taiwan have already opened consultations on the E19 document, while regulators in Brazil, Europe, Canada, Korea, Japan, China, Switzerland and Taiwan have begun consultation on the M10 guideline.
Speaking at an event in April, FDA officials said the E19 guideline is expected to reach Step 4 in June 2021 and the M10 guideline is expected to reach Step 4 by November 2020.
While both guidances are presented in ICH's original format for the consultation, FDA says the final versions will be reformatted to meet its good guidances practices and style requirements.
The 10-page ICH E19 guideline details a "selective approach" to gathering safety data in late-stage premarket and postmarket settings.
FDA says the E19 guideline "is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information."
FDA also says the guideline is consistent with risk-based approaches and quality-by-design principles and would enable larger studies to be carried out more efficiently.
ICH's M10 guideline is aimed at enabling sponsors to improve the quality and consistency of bioanalytical data to support the development of new drugs and biologics.
The 59-page guideline lays out recommendations for validating bioanalytical assays for nonclinical and clinical studies conducted to generate data to support regulatory submissions, which FDA says will clarify regulatory expectations for industry.
FDA also says the guideline "describes the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects."
E19 Draft Guidance, Federal Register Notice
M10 Draft Guidance, Federal Register Notice

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