• Regulatory NewsRegulatory News

    ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards

    The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual solvent testing, carcinogenicity testing, and specifications for submitting applications in the electronic Common Technical Document (eCTD).   ICH made this 10 June announcement following a virtual meeting of the ICH Assembly. During the meeting, the ICH Assembly adopted several guidelines for Step 4 of t...
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    ICH announces sign-off of residual solvent guideline

    The International Council for Harmonization (ICH) recently announced that its guideline establishing new permitted daily exposures (PDEs) for three residual solvents had reached Step 4, meaning the guideline can now be implemented by regulators.   The ICH Q3C(R8) guideline has been revised to include permitted daily exposure (PDE) levels for 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME) and tertiary butyl alcohol (TBA). The PDE for 2-methyletrahydro...
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    FDA Updates on Two ICH Guidelines

    The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents. For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy , w...