Pharmaceutical Executive Europe - September 2008 - (Page 24) Regulatory Affairs widely between companies. One problem that arose from the process is the institutions’ disparate approaches. While EMEA is a scientific institution, whose role is to examine the adequacy of elements of a clinical trial authorisation submitted in support of an application for marketing authorisation, FDA’s responsibilities are much broader and the association perceives itself as having a different role. In brief The Transatlantic Economic Council (TEC) was established at the EU/US Summit in April 2007. ● In May this year the TEC decided to ‘intensify’ transatlantic co-operation in the pharmaceutical arena. ● FDA and EMEA will commence joint inspections of pharmaceutical facilities later this year. ● There are concerns, however, that the joint inspection initiative could suffer the same setbacks as the existing Parallel Scientific Advice Programme. ● Furthermore, EMEA has even acknowledged that companies were reluctant to be ‘guinea pigs’ in the PSA process. In addition, some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence, and that the procedure added to the administrative burden rather than lightening it. The systematic differences inherent in the regulatory bodies partly explain this disparity — while the EMEA had one group dealing with scientific advice, the FDA split the process among various divisions. of pharmaceutical areas including biomarkers, innovative medicines initiatives, product specific risk management, biosimilars and advanced therapy medicinal products, as well as inspections, which they aim to streamline through closer collaboration based on the ‘cluster’ concept. This involves bringing together experts in the field to discuss the issues and formulate ideas and recommendations. procedural ways of cooperation; for example, with regard to conducting the inspections or drafting the inspection reports. The first joint inspection results are expected at the end of 2009. Only then will we know if this plan can really come together. ■ About the author Fabien Roy is a legal assistant at Hogan & Hartson, Brussels, Belgium. He can be contacted at froy@hhlaw.com Towards 2009 So does this mean the EU and the US have learned the lesson of the PSA setbacks? Are companies now likely to have more confidence in the efficiency of these collaboration projects? Caution must be the key word for the time being and expectations must always be put into perspective. The PSA example highlighted the problems in transatlantic collaboration and those weaknesses could continue to plague the new inspections initiative. While in theory unity leads to strength, FDA and EMEA will now have to show that they are able to manage this initiative in practice. According to the EC, the pilot joint inspection phase will help to evolve Perfecting the plan For the new initiative, however, the regulatory bodies seem to have opted for a more efficient approach by launching joint — not parallel — inspections to try to avoid facing the criticisms that plagued the PSA. But it seems that the PSA’s poor results have not affected the regulatory bodies’ morale. On 17 June 2008, FDA and EC together unveiled their new Transatlantic Administrative Simplification Action Plan, under which they demonstrated their willingness to develop closer collaboration in a number 25 Last Words The month’s key events from the industry’s mouth. 4 News A round-up of the last four weeks in pharma. 7 Calendar Upcoming conferences and exhibitions. 10 Brussels Report Competition between the bioindustry associations.
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