Editorial: A real chance for a seismic shift in moving the risk and science based approach forward.

The author applauds the announcement that Annex 1 requirements under a national application of the Pharmaceutical Inspection Cooperation Scheme regulatory programme in Europe will be subjected to a root and branch revision. Topics discussed include the author's experience with working a firm in Southeast Asia, an example illustrating the lack of clarity in the document, and the guidance on airflow velocity in Grade A unidirectional airflow systems.