Tor Graberg

Changing times

Today, the organization has grown from 10 original European country members to 39 participating authorities from five continents. An additional nine authorities from countries such as Brazil and Indonesia, are in the process of becoming members. Paradoxically, the growth of the organization has been made possible by moving from a legally-binding MRA (PIC) to an informal arrangement between regulatory authorities that better facilitates cross-border trade of pharmaceuticals while ensuring the safety of patients.

The expansion of the PIC/S mission illustrates how successfully the organization has been able to adapt to a constantly changing environment—in particular, globalization. The increasing globalization of public-health issues and the multiplication of actors involved (both in industry and among regulatory authorities) has made it necessary to increase harmonization efforts in setting regulatory requirements, inspecting and evaluating GMP compliance, licensing manufacturing sites, recalling defective batches, and the exchange of information. The philosophy of PIC/S is based on cooperation, communication, and trust. Because information-sharing within PIC/S is voluntary, it is up to the receiver of the information to decide how to use it (e.g., a participating authority can use the outcome of an inspection conducted by another PIC/S authority to avoid duplicating an inspection).

FDA's membership

FDA has acknowledged PIC/S' efforts. The agency applied for PIC/S membership a few years ago and became an offical member in January 2011. PIC/S invited FDA Commissioner Margaret Hamburg, MD, to deliver a kenote address at the May 2011 anniversary celebration (1). In this address, Hamburg called upon all regulatory authorities to cooperate more closely and to share information on GMP inspections.

Due to the globalization of the supply chain, a growing part of finished products and APIs are imported. Globalization represents not only new opportunities for manufacturers but also considerable challenges for regulators. As Hamburg asserted, "...no one country is capable of inspecting the world on its own, nor can we assure quality with inspections alone" (1).

All PIC/S members, including FDA, need to think about how to best pool resources and work together to protect public health. For FDA, PIC/S represents a key way to avoid the duplication of efforts and ensure the global security of the supply chain. Hamburg concluded her speech by saying, "Today, PIC/S is more important than ever, given the realities of globalization" (1).

The FDA Commissioner's speech is remarkable on at least two counts:

• As Hamburg underlined—and this is also valid for other countries, "In the US, a stunning 80% of the active pharmaceutical ingredients in our drugs come from outside our borders and about 40% of the finished drugs themselves" (1). Because neither the US nor any other regulatory authorities can inspect all imported medicinal products (including APIs), cooperation with other authorities is vital to get the most possible amount of information that a single regulatory agency's inspectors cannot gather.
• FDA is willing to use PIC/S as a tool to better safeguard the health of Americans. Following the heparin crisis of 2009 and 2010, the soundness of regulatory action, within the national borders and without foreign cooperation, has been seriously questioned. A repeat must be avoided at all costs. Said Hamburg, "We must continue to work together in a proactive, rather than reactive, manner in dealing with potential threats" (1). In addition, the international financial crisis will affect budgets and limit the amount of money that governments will spend on healthcare. As a result, cooperation with other regulatory authorities in the framework of PIC/S has become a strategic and financial priority for FDA.