EMA and FDA agree to maintain collaboration indefinitely

This cooperation will now continue indefinitely without the need for further renewal, allow the exchange confidential information as part of their regulatory and scientific processes. The types of information include scientific advice, orphan drug designation, paediatric development, good manufacturing practice and good clinical practice inspection planning and reports, marketing authorisation procedures and subsequent changes to the marketing authorisations together with post-marketing surveillance.

One of the main factors driving the need to exchange information is the offshoring of clinical research and drug manufacturing from the US and Europe is forcing the two agencies into closer cooperation as they strive to oversee and maintain safety and quality standards.

In paediatric medicine for example, which is one of the key areas of collaboration between the FDA and EMA, there are monthly teleconferences. More than 570 paediatric drug development plans have been exchanged with the aim of enabling global development plans to be agreed for both regulators, reducing the number of children in trials.

The pressures of globalization also demand increased regulatory cooperation. The drugs regulated by the FDA, EMA and others, are global commodities, with widely dispersed manufacturing, international supply chains and supporting databases spread over different geographies. FDA-regulated drugs are imported to the US from over 200 countries and in all, 40 per cent of finished drugs and 80 per cent of active pharmaceutical ingredients now come from overseas.

And as mass production of drugs is now possible, so too is large scale counterfeiting. While the Internet means safety information can be communicated instantaneously, rogue online pharmacies can come and go overnight too. Ease of travel makes it possible to speedily distribute drugs, but also means contaminated products can be anywhere in 24 hours.

The change has happened very quickly, with the number of drugs manufactured outside the US doubling between 2001 and 2007. In clinical trials too, the last couple of years has seen a shift away from North America and Western Europe, to Eastern Europe and South America. As a result, regulators need to carry out good clinical practice inspections in all parts of the world. The FDA and EMA now inform each other of what inspections they are doing, to avoid duplicating effort.

Offshoring clinical trials also raises issues around differing ethical standards, posing the question of whether the FDA and EMA should allow data in trials deemed to be ethical where they are carried out, but which do not match the ethical standards either regulator would demand in their home markets.