FDA to join PIC/S

On 8^th and 9^th November the Pharmaceutical Inspection Cooperation scheme (PIC/S) met in Kuala Lumpur Malaysia. The main news to come out of that was that the US FDA will become full members of PIC/S as of 1^st January 2011.  Some commentators may be saying “about time too” but what does it actually mean to the industry?

The FDA has rightly or wrongly been thought of (at least in the USA) as having the highest standards in the world for pharmaceutical products and medical devices. However the FDA applied for membership of PIC/s as far back as 2005.  So why have they not joined?

It was rumoured that under the previous US Administration there was a reluctance to allow overseas Agencies  review the FDA's own internal quality management system, which is required for new members to join PIC/S.

Another reason, if recent press reports are anything to go by, is that the PIC/s organization looked at the FDA regulations and concluded that they were insufficiently rigorous for admission to PIC/S.  Given that the FDA has now been admitted, it is an open question as to how far the FDA will go to comply with the full intentions of the scheme. Will this mean a tightening of regulations or just reciprocal recognition of inspections?

At the same time as the FDA joins PIC/S the Ukrainian regulatory agency (SIQCM) is being admitted too.  Does this mean that inspections of pharmaceutical plants in the Ukraine by the SIQCM will be recognized by the FDA as being of the same rigor as their own inspections?  This is as much a political as a regulatory question and it remains to be seen how far the FDA is prepared to go to comply with the PIC/s principles, and whether we can expect any change to regulatory law or guidance in the USA as a result.

[Posted on behalf of David Hawley]