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On 27 June 2006 the EMEA published the document EMEA 120457/2006 Procedure
for Worksharing – Quality Variations.
This document outlines an approach for cooperation between individual
EU member states’ National Competent Authorities (NCAs) for dealing with
submitted variations to a product that has been authorised in various
member states. With this regulation EMEA intends to simplify the decision
process between the involved authorities.
For now the new procedure is limited to variations introducing
elements of PAT (Process Analytical Technology) and /or a
design space as described in ICH Guideline Q8, where it includes PAT
principles.
The new regulations’ goal is to ensure a harmonised assessment in
this relatively new field.
Authorisation holders currently planning variations introducing PAT
elements are invited to participate in the pilot phase of this project.
The document shows that European Authorities too consider PAT a
quite important issue.
The complete document can be downloaded here:
http://www.emea.eu.int/Inspections/docs/12045706en.pdf
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