Regulatory Centralised


submission


The change from the Clinical Trials Directive to the Clinical Trials Regulation in Europe has been long and slow, but now that the new regime is in place there is one burning question – has it produced the improvements that regulators were expecting? Jim Banks puts that question to Alexander Roussanov, life sciences and privacy partner at law firm Arnold and Porter Kaye Scholer LLP, and Edyta Maciołek, regulatory affairs manager at JJP Biologics.


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t is a commonly held belief that one can pass from one EU member state to another without noticing they’ve crossed a border. Nevertheless, a much- repeated anecdote says that if you travel by bus from the Netherlands to Belgium, you can tell the very instant you cross the line between the two countries because the wheels are no longer rolling smoothly on pristine tarmac but are hitting potholes. In many ways, this echoes the world of regulatory affairs, where supposedly harmonised rules are often


implemented very differently across member states. This has become evident in 2023 with the introduction of the Clinical Trials Regulation (CTR) to replace the Clinical Trials Directive that had governed trial activity for more than a decade.


The EU made the bold decision to transition to CTR back in 2014, aiming to bring in a new regime to bolster the safety and ethical conduct of clinical trials in relation to investigational drugs. The new framework rests on the Clinical Trials Information System (CTIS) –


Clinical Trials Insight / www.worldpharmaceuticals.net


rudall30/Shutterstock.com


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