Will FDA join PIC/S this Year?

Probably before the end of the year, the FDA will become a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Therefore, during the next PIC/S Conference in Kuala Lumpur (Malaysia) in November 2010, the PIC/S Committee Meeting is to decide about accepting the FDA as a full member. This was stated by Benda Holman (Executive Director, ORA Strategic Initiatives, ORA, FDA) at the PDA/FDA Joint Regulatory Conference in Washington on 14 September 2010. Mark Tucker, Senior Director GMP Compliance at Genentech /Roche and former FDA Compliance Officer, reported about the conference during an ECA event.

Now does this mean that the FDA will not perform any more inspections in PIC/S member states? It will probably not come to that yet.

The recognition of GMP inspections is not possible for individual member states of the EU, since formally only the European Commission can sign international agreements. In this case, this would be an MRA (Mutual Recognition Agreement). However, the European Commission is not a PIC/S member. Theoretically, the FDA could now recognise inspections conducted by authorities of EU member states unilaterally, as the PIC/S leaves it up to its members to decide about this individually. Yet, there is no automatic recognition of inspections; in this context, the PIC/S itself merely speaks of "exchange of information".

As the follow-up programme to the Pharmaceutical Inspection Convention, the PIC/S is an international programme for co-operation in the field of pharmaceutical inspections, but not for the mutual recognition of inspections. The key target is the development of harmonised standards.

On the PIC/S homepage you will find essential background information.

There you will also find an overview of the differences between PIC/S and its predecessor organisation PIC: 

PIC/S PIC
Scheme Convention
An informal arrangement a formal treaty
has no legal status has legal status
between health authorities between countries
Exchange of information Mutual recognition of inspections

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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