eCTD NEWS
RECENT NEWS
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EMA Regulatory and procedural guideline: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)(updated) Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope...
MHRA Completed Paediatric Studies - submission, processing and assessment - 1 February 2023 – Guidance
EMA Clinical Trials Information System (CTIS): online modular training programme(updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
EMA European Medicines Agency post-authorisation procedural advice for users of the Centralised Procedure Clean Version / Tracked Version (updated) European Medicines Agency Pre-authorisation guidance - Clean Version / Tracked Version (updated) Regulatory and procedural guideline:...
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EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated PLM Portal eAF timeline now...
EMA Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams (updated) Template or form: Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical Clinical Trials Information System (CTIS): Walk-in clinic - March...
EMA EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions News and press releases: New features further strengthen Priority Medicines scheme (PRIME) Medical devices (updated)
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