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Transatlantic regulatory cooperation expanded
As drug regulation continues to hold the spotlight, the expansion of an initiative to strengthen cooperation between regulatory agencies in the United States and Europe has been welcomed.
Bethan Hughes
The US FDA, the European Commission and the EMEA have agreed to expand their cooperative activities in several important areas, including paediatric drugs, medicinal products for rare diseases and risk management. A key aim, according to Gnter Verheugen, Vice President of the European Commission for Enterprise and Industry, is to: prevent divergences and ensure the best use of resources.
This type of initiative canbe very positive if done in a thoughtful way, says Caroline Loew, Senior Vice President for Scientific and Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA). If you go back20 years, companies were often pursuing largely independent drug
development programmes for the US, Europe and Japan because of differences in the regional regulatory requirements. But there is now substantial commonality between them for example, the total body of non-clinical data required is now harmonized between these regions.
This progress, and the benefits of reduced costs and time spent owing to the elimination of unnecessary duplication of test procedures, has been largely due to the International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH; http://www.ich. org). Since its conception in 1989, the efforts of the ICH, whose core members represent the regulatory bodies and the research-based industry in the EU, Japan and the US, led to the introduction of the Common Technical Document in
2003, which harmonizes much of the documentation for drug applications in these regions.
The latest initiative to be announced further extends effortsto promote cooperation between the FDA and EMEA that were initiated when the two agencies signed a confidentiality agreement to enable the sharing of information in 2003. Interactions between the EMEAand FDA are now occurring multiple times every day through e-mail, teleconferences, face-to-face meetings and secondments, says Verheugen, this is down to the creation ofsafe conditions within which the regulators and...