The MedTech Europe blog

Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time when imports into the USA were few and could be inspected at the port of entry. ‘A new set of tools and capabilities was required’ and recognition of the global nature of markets and the ever increasing complexity of technologies made it inevitable that transnational collaboration would be needed.

Later in the day Lilian Gill, a Director at the FDA who sits on the Global Harmonisation Task Force, further emphasised the challenge in stating that ‘we don’t have the resources and we don’t believe any other regulator has the resources’. Indeed, if the FDA feels under pressure to deliver its statutory duties with the cohorts of staff at its disposal what hope is there for any other nation or group of nations such as the European Union.

All of this points towards a serious dialogue between nations designed to create a robust global network of regulators with shared processes and standards. Most importantly there is a need to build trust through vigorous work programmes designed to create a level playing field. The prize for getting this right is, indeed, enormous. Current duplication of effort by regulators asking essentially the same set of questions is wasteful (I have been in plants that have been audited by four different authorities in the space of three months with a 90% plus overlap of requirements) and despite this a large numbers of suppliers slip through holes in the net and don’t receive adequate scrutiny in many parts of the world. Effective cooperation on a global system will enhance patient safety, allow regulators more confidence that they are fulfilling their obligations and cut costs which can be directed to treating patients rather than occupying duplicative bureaucracies.

The upcoming steering committee of the Global Harmonisation Task Force could grasp the nettle of driving a real political coming together on the need to translate the excellent job done on the guidance which now underpins most of the world’s regulatory systems and taking real cooperation to the next level. This will neither be easy nor quick but there has never been a better time to do it as all regulators feel the heat of financial crisis-driven cost-cutting and increasing expectations from those who put them in the job.

John Wilkinson
Eucomed Chief Executive

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