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Good clinical practice specific to advanced therapy medicinal products

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance.

Related topics

Healthcare industries

Deadline:  15/10/2008

See also:  Public consultation paper (web archive)

Contributions to this public consultation should be sent before 15 October 2008.