On 26 April 2023, the European Commission (EC) proposed reforming the European Union (EU) pharmaceutical legislation. This revision constitutes the first major overhaul of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
The new European Union (EU) legislation regulating clinical trials harmonises the processes for assessment and supervision of clinical trials throughout the EU. It enables sponsors to submit 1 online application via a single platform (CTIS) for approval to run a clinical trial in several European countries, making the conduct of such multinational trials more efficient.
In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.
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