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2023 European regulatory update: one-portal submission Clinical Trials Regulation comes live
From now on, there is no going back. Are you ready for the new era of clinical research in the EU?
February 3, 2023
The European Medicines Agency (EMA) has hit an important milestone in its clinical research regulations. Since January 31, 2023, under the Clinical Trials Regulation (CTR – Regulation (EU) No 536/2014), all initial clinical trial applications in the European Union must be submitted via a single EU portal – CTIS (Clinical Trials Information System). Such submission will be followed by an assessment procedure resulting in a single decision for clinical trial authorization in Europe.
This procedural innovation is expected to become a game changer rendering Europe a competitive and attractive region in the global clinical research market, especially regarding multinational clinical trial conduct. With a single portal submission, the EMA opens the way for sponsors to simultaneously apply for authorizations in up to 30 EU/EEA countries with the same set of documentation leading to the simplification and harmonization of procedures.
Such opportunity may become quite advantageous specifically for sponsors running trials for rare diseases or in challenging indications where patients are typically spread out among a varied number of countries. Moreover, the unified CTIS system includes a publicly searchable database for patients, healthcare professionals, clinical research associations, and other interested parties making the EU clinical trial data more transparent and accessible.
EU Clinical Trial Regulation overall regulatory strategy considerations
From now on, the EU member states have 60 days to evaluate an initial application; however, the deadline may be extended in case requests for additional information (RFIs) are submitted by a Member State Concerned (MSC) during the process of evaluation. Therefore, sponsors need to focus on the quality of the submitted documentation and be ready for prompt answers to RFIs within the deadlines outlined by the Member State Concerned (MSC) to avoid the lapse of the clinical trial application.
Despite good intentions and benefits associated with the introduction of the obligatory submission procedure for all new clinical trial applications, many sponsors and CROs are concerned about potential pitfalls that could incur during the transitional period on an “unprobed territory”. The biggest trap could become delays in clinical trial authorization, especially in popular among sponsors countries such as, for example, Germany or Belgium, if those get selected by the sponsor as their reporting Member State. There is a hefty chance that, with the introduction of the new procedure, national regulatory authorities would be overloaded with applications aiming to render one of those countries as the primary gateway to Europe.
Consequently, to avoid the risks associated with such overload, Accell could suggest an alternative strategy by entering the European clinical trials environment via less ‘crowded’ EU countries located in the Eastern part of Europe. In recent years, many Eastern European countries have updated their regulatory legislation to adopt and harmonize it with the transitioning CT Regulation to make sure procedures and timelines meticulously coincide with European requirements. It is paramount to stay up-to-date and contemplate well in advance the regulatory strategy to max out the chances of an unhindered clinical trial application authorization.
At Accell, we are ready to help sponsors enter the in-demand European clinical research landscape via applications submission via Romania thanks to our 15+ years of experience working with regulatory authorities in Eastern Europe, an office located in Bucharest, and an experienced team knowing all nuances of clinical trials conduct in Europe. We are ready to embrace the new challenge of the updated regulation and to make sure our sponsors experience a smooth path toward a successful clinical trial completion.
Get in touch with our team at firstname.lastname@example.org to discuss your particular clinical research needs and to learn what clinical trials strategy Accell can suggest in order to improve your clinical trial performance, efficiency, and overall cost-effectiveness.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC | accessed on February 3, 2023
Clinical Trials Information System: training and support | accessed on February 3, 2023