EMEA supports PAT for Variations

 
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

Two representatives from European and US Authorities – Prof Christina Graffner (Swedish Medical Products Agency) and Dr Chris Watts (FDA) – will also be present.

 
Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)