Content tagged with EMA

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The EMA Draft Guideline On A GCP Compliant Trial Master File

The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”

First guidance on new rules for certain medical devices

EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices .