FDA's membership of PIC/S - why it is important

At the end of 2010, the PIC/S Committee officially invited the US-American health authority FDA (Food and Drug Administration) - and the Ukrainian authority SIQCM - to join the Pharmaceutical Inspection Co-operation Scheme as from 1 January 2011. After that step was made, a lot of questions were raised about the possible impact of this decision.

Now, Dr Margaret A. Hamburg, Commissioner of the FDA, gave an interesting talk at the 40th anniversary of PIC/S in Geneva, Switzerland, emphasising the importance of PIC/S in a globalized world.

The process of admission to PIC/S took some time. And it seems that already during this process, a lot of benefits were gained. Hamburg outlined that during the application process, the FDA was forced to look at its own processes and see where the agency could do better. "Because FDA's system is different from the European system, it took a lot of work to consider how to compare our system to those of many of the existing members. There was a great deal of productive dialogue, and we very much appreciated the candor and openness of the PIC/S assessment team" Hamburg said. It might also be seen as a start for an enhanced co-operation and collaboration processes with other agencies and inspectorates, not only PIC/S.

In this context Commissioner Hamburg stressed the need for leaders and experts to "come together and collaborate even more than ever before". All can "work together to assure that regulators around the globe have common knowledge, tools and practices, so that they can best work together." And that the FDA already "works together with the European Medicines Agency and its member state inspectorates on drug product inspections, and with EMA and the Australian Therapeutic Goods Administration on active pharmaceutical ingredient manufacturer inspections in various parts of the world."

Commissioner Hamburg also outlined other benefits: "networking with our counterpart regulatory authorities, sharing training opportunities, promoting quality systems, as well as participating in Quality Circles and other committees and working groups."

And what about inspections?

Let's be honest. Quite a few companies especially in Europe were or are still hoping now that FDA is member of PIC/S, the agency will stop performing inspections at least in PIC/S member states. However this is currently not the case.

But there is a tendency that FDA will have a closer look at inspection reports of other agencies and inspectorates - especially in the case of problems. Hamburg presented a recent example to demonstrate this new development: "In this case, the U.S. FDA relied on the European Directorate for the Quality of Medicines to place a firm under Import Alert and prevent its active pharmaceutical ingredient from entering our country. We made this decision solely on EDQM's information, even though FDA had never inspected the manufacturing site. To make this decision, which was an unprecedented one for us, we learned about the deficiencies by monitoring an EU database; requested and reviewed EDQM's establishment inspection report; and had detailed technical discussions with the inspectors. Now, we are working to conduct a joint inspection of the firm with EDQM."

One key element of all these co-operation efforts is a new web portal on FDA's inspection activities, called COMSTAT. By using the database one can easily find any company that has been inspected by FDA and receives information about the inspection outcome. "We also believe that global data-information systems and networks are imperative, so that we can proactively share data with our partners. This would begin with inspectional results or GMP certificates and hopefully extend to include inspection reports and inspection schedules", Hamburg said.

Source: Speeches by FDA Officials

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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