Clinical Development

In this section you may find indication on the role and function of clinical studies in research and drug development.

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EU Compassionate Use Programs

Published by IRDiRC

Regulatory AffairsResearch and Drug DevelopmentClinical DevelopmentOrphan DrugEarly Access SupportEuropean UnionCompassionate UseEMA Compassionate Use

Compassionate 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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ICH E6 (R2) Good clinical practice

Published by EMAInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Good Clinical Practice (GCP)Ethics Committee

This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

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Good clinical practice

Published by EMA

Good Clinical Practice (GCP)Clinical Trials

The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications to the EMA (through the centralised procedure) or to National competent Authorities (through decentralised, mutual recognition, or national procedures) . The Paper set up practical steps to be undertaken during the provision of guidance and advice in the medicine development phase and during the evaluation of Marketing Authorisation Applications.

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