Regulatory Science

The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.

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DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.

Published by European Commission (EC)

Genetically Modified OrganismsGMO

This Directive set the regulation of the environment of genetically modified organisms. The protection of human health and the environment  from the deliberate releaset of genetically modified organisms 

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Preparedness of medicines’ clinical trials in paediatrics. Recommendations by the Enpr-EMA working group on trial preparedness. EMA/56009/2019.

Published by European Medicines Agency

Clinical TrialsMedicinesPaediatrics

This document focuses on preparedness for individual trials. However, as a development plan would normally constitute a number of trials, it is implicit that the same elements would also be relevant for preparation of a complete plan. Trial “feasibility” is the likelihood of completing a trial in a timely manner. This document moves beyond the definition of “feasibility” to present a global determination of all aspects of a trial that need to be
prepared.

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