The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of clinical trial data.
The guideline provides a unified framework to facilitate the mutual acceptance of clinical trial results by regulatory authorities across ICH member regions, supporting global collaboration in drug development and ensuring consistent regulatory standards.?
Clinical Development
In this section you may find indication on the role and function of clinical studies in research and drug development.
FDA Qualification process – Drug Development Tools
Published by IRDiRC
Animal ModelBiomarkerCenter for Drug Evaluation and ResearchClinical DevelopmentDrug Development ToolEndpointQualification ProcessRegulatory AffairsResearch and Drug DevelopmentThis guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.
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Japan Compassionate Use Programs
Published by IRDiRC
Clinical DevelopmentCompassionate Use ProgrammeEarly Access SupportMHLW or PMDA RegulatoryRegulatory AffairsA system for patients with life-threatening conditions without effective a treatment to gain access to unapproved investigational medical products.
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EU Compassionate Use Programs
Published by IRDiRC
Clinical DevelopmentCompassionate UseEarly Access SupportEMA Compassionate UseEuropean UnionOrphan DrugRegulatory AffairsResearch and Drug DevelopmentCompassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.
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National programs for early access
Published by IRDiRC
Clinical DevelopmentCompassionate UseRegulatory SciencesSometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available
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