Dr. Thomas Zimmer was named ISPE Vice-President of European Operations in November 2013 and this year he will shoulder responsibility for the first ISPE Europe Annual Conference. In an interview with PROCESS Worldwide, he explained why ISPE will develop its network with european regulators and how the conference will contribute to a new quality awareness.
Dr. Zimmer, ISPE is perceived to be heavily dominated by America. Is this first ISPE Europe Annual Conference an indication that Europe is starting to play a more significant role in the organization?
Zimmer: It is true that the ISPE is still seen as being very US-centric. However there is growing recognition for the need to pay more attention to Europe and to listen more. If that were not the case, the ISPE would not have a Vice-President for European Operations. ISPE now understands that solutions which work well in America cannot simply be transferred to Europe on a 1:1 basis. If you take a look at the EC GMP Guide, you see that many chapters are currently being revised. We have a lot of work ahead of us.
Compared to the FDA, the EMA is much more active and above all much more specific. The basic GMP principles are the same, but there are definitely differences in the details. Despite all of the harmonization efforts, there is a tendency for the differences to become bigger rather than smaller. As EMA now sets the tone, the Europeans have clearly emancipated themselves from the Americans. That fact that the Australians and Chinese are heavily influenced by the EC GMP Guide is a clear indication of this. As a result, the FDA is not automatically seen as the world standard when solutions are being developed. Europe now plays a crucial role.
What are the essential differences between Europe and the US?
Zimmer: To start with, the regulatory system in Europe is completely different. To cite two examples, most production registration in Europe is organized at the national level. Around 80 %–85 % of all drugs are approved at the national level and only 15 %–20 % by the EMA.
In addition, EMA does not conduct any audits in Europe. The EU countries have audit responsibility, and the audits are usually administered by regional commissions or public health bodies. Outside the EU, the authorities of EU member states carry out audits on behalf of the EMA.
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