• Feature ArticlesFeature Articles

    The transition to ICH M10 and its impact on global submissions

    With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...
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    FDA launches global Generic Drug Cluster

    In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug Cluster.   Described as “the first forum established for the world’s leading regulatory agencies to address generic drug development globally,” the new cluster, wrote FDA, is meant to help harmonize approaches global regulators take to generic drug development through a variety ...
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    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 Q12: FDA guidance explains US implementation

    The US Food and Drug Administration (FDA) has issued draft guidance to help manufacturers implement the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes by explaining how manufacturers can submit established conditions (ECs) for new drug applications (NDAs) and prior approval supplements (PASs). It also reconciles ICH post-approval changes classification categories with FDA supplement categories.   A Federal Register announcement ...
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    ICH: MIDD concept paper coming by year’s end

    Regulators are increasingly interested in developing model-informed drug development (MIDD) programs, but some barriers still impede their more widespread adoption.   Among these is a lack of common understanding of MIDD between technical and non-technical experts, asserted Scott Marshall, executive director for Pfizer Research and Development in the UK, in a 15 May update on the progress being made by an International Council for Harmonization (ICH) discussion group o...
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    Euro Convergence: Academic clinics should establish risk management programs for ATMP development

    Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies.   So asserted Lutz Uharek, a professor of internal medicine and founder and CEO of Xencura, at RAPS Euro Convergence 2021 on 12 May in discussing some of the challenges and opportunities for academic centers in developing cell and ge...
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    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonisation (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.   The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with the I...
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    FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

    The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.   The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a ...
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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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    ICH announces new data exchange with SNOMED to promote drug safety

    The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.   This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety. The ICH Medical Dictionary for Regulatory Activities (...
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    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
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    ICH updates focus on patient-focused drug development, nitrosamines

    The International Council for Harmonisation (ICH) has shared an update on its initiatives, revealing recent progress in areas including its position on elemental impurities and the role patients can play in drug development.   ICH met virtually last month in lieu of a face-to-face gathering that was to take place in Greece. At the event, ICH’s second virtual gathering of 2020, the management committee re-elected FDA’s Theresa Mullin for another one-year term as manag...