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NZ and Taiwan join PIC/S; API inspection scheme makes progress

31-Oct-2012

New Zealand regulator Medsafe and the Taiwan FDA will join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) next year.

The announcement – which was made during the PIC/S meeting in Kiev, Ukraine earlier this month – will see the organisation become the 42nd and 43rd authorities to join the international harmonised good manufacturing practices (GMP) group.

The meeting also saw discussion of the active pharmaceutical ingredient (API) Inspector training Programme, which was developed in response to requests from several national drug regulatory agencies.

The programme – the first training session was held at a PDA (Parenteral Drug Association) event in Beijing, China earlier this week – is designed to teach inspectors how to interpret ICH Q7 requirements with a focused on inspection techniques.

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