EU and US to widen co-operation
Regulatory co-operation between the EU and the US is to be expanded to include confidential exchanges of information on paediatric medicines and orphan drugs.
The European Medicines Agency (EMEA), the European Commission and the
US Food and Drug Administration have agreed regularly to exchange information
on scientific and ethical issues and other information on paediatric
developments in the EU and US in order to avoid unnecessary clinical
trials involving children, as well to exchange more information on orphan
drugs.
Information that will be exchanged includes paediatric investigation
plans, requests, deferrals and waivers from the requirement for such
plans, and safety-related information, such as reports of adverse drug
reactions in children.
They will also develop a framework for global paediatric development
plans that meet the needs of both the EU and the US.
The EU and the US started confidential exchanges of medicines regulatory
information in 2003 and agreed in 2005 that this would continue for a
further five years. Product-related information can only be exchanged
for products that are licensed under the EU’s centralised licensing
procedure.
EMEA application
templates The EMEA has now published templates
to be used by companies wishing to apply for paediatric investigation
plans,
deferrals or waivers
under the new licensing rules that require medicines to be tested for their
suitability for treating children, along with timelines for the submission
of applications. |
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