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The University of Basel compared the regulatory requirements for the approval of new drugs in 12 countries. It found that different approval requirements lead to higher costs – and higher drug prices.
New drugs have to overcome a number of regulatory requirements before being approved for the market, among them fees, studies and evaluation periods. According to the University of Basel, these are known to be a significant time factor in drug development.
As the approval requirements in the 12 countries and regions examined in the study differ, these prolong the time until new drugs make it onto the market, which also impacts their price. Harmonisation of these approval requirements and processes could therefore significantly reduce the costs.
“Patients would profit especially since new drugs would be available faster and at lower prices”, said Thomas D. Szucs from the European Center of Pharmaceutical Medicine at the University of Basel.
The university compared the approval requirements in Switzerland, the EU, the US, Japan, China, India, Brazil, Singapore, Russia, the UK, Canada and Australia. The results were recently published in the journal Nature Review Drugs Discovery.
The differences even affect the manner in which the documents must be submitted. While many countries including Switzerland permit electronic submission, China and India require a hard copy of the documents. And while the dossier structure is similar across the countries in regions, there are major differences in processing times and costs. For example, Swissmedic takes around 12 months, Russia 110 working days, and Brazil up to two years. Swissmedic charges fees of a maximum CHF 70,000, compared to the EU which charges around EUR 280,000.
The differences also apply to the standards and processes used when evaluating identical products, and certain aspects are also reviewed and assessed multiple times and in various ways, according to the University of Basel.
“This suggests that companies and authorities should strengthen their international collaboration and communicate better with each other”, Szucs said.