Conducting clinical studies requires a planning horizon and is associated with high costs. Planning the studies requires clarity in timeframes and smooth management in relation to authorities and trial providers. Unpredictable timeframes and long lead times create delays that lead to high additional costs. Factors that encourage companies to go abroad for their studies.
Businesses want the authorities to be a fast-moving partner with the resources to ensure a smooth and coordinated licensing process. Adapting the permit process to the new EU regulation will create the conditions for a more coherent and transparent permit process. However, making companies and researchers bear the entire cost of the transition to the new systems sends a counterproductive signal to companies. The planned 250-300% increase in the cost of licensing is hitting the small, young, innovative companies that are already the least likely to get the process right and therefore most likely to incur additional costs associated with delays and changes.
Significantly increasing the fees for clinical trials is not in line with the intentions to increase the number of clinical trials in Sweden.
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SwedenBIO’s opinion on the referral of Fee changes as a result of the EU regulation on clinical trials of human medicines.
“To make it easier for businesses and researchers, it is important that authorities are transparent and that the basis for decisions is consistent over time. It is very good that the Medical Products Agency offers the possibility of counseling and it is my hope that this possibility remains at a low cost and with reasonable timelines.”
Marie Gårdmark, RegSmart
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