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Clinical Trials in Spain Accelerated: AEMPS Launches Fast-Track Evaluation Procedure

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The Spanish Agency of Medicines and Medical Devices (AEMPS) has introduced an innovative fast-track evaluation procedure for clinical trials, aimed at making Spain a more attractive environment for the research and development of innovative medicines. This new procedure promises to significantly reduce the timelines for the evaluation and authorization of clinical trials that meet specific criteria, enhancing Spain’s competitive edge in the global pharmaceutical research landscape.

Under the standard regulations set by the European Union, specifically Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use, there are established maximum timelines for the validation and evaluation of authorization requests submitted across the EU. Typically, these processes can be lengthy, potentially delaying the initiation of critical research. However, the AEMPS’s new fast-track procedure aims to expedite these processes for qualifying studies, reducing evaluation times to a maximum of 26 days, with the possibility of authorization within as few as 31 days. This reduction represents a significant improvement, cutting standard timelines by up to 30%.

The fast-track procedure will be available to clinical trials that fulfill several stringent criteria. First, the trial must be a Phase I clinical trial, focusing on the initial assessment of the safety and tolerability of the investigational drug. Second, the trial must involve advanced therapy medicinal products (ATMPs), such as gene therapies, somatic cell therapies, or tissue-engineered products, which represent cutting-edge advancements in medical treatment. Third, the trial should target diseases that are severely debilitating or life-threatening and for which there are no existing therapeutic alternatives, thereby addressing urgent and unmet medical needs.

Exclusive CTIS Submission and CEIm Requirements for Clinical Trials

The application for the clinical trial must be submitted exclusively through the EU’s Clinical Trial Information System (CTIS) and must be conducted solely within Spain. This centralized and streamlined submission process is designed to facilitate quicker and more efficient evaluations.

In addition to these requirements, the Ethics Committee for Research with Medicinal Products (CEIm) selected by the sponsor must be one of those adhering to the fast-track procedure. The contact details for these CEIms are available in the Directory of Accredited CEIms in Spain, ensuring that sponsors have access to the necessary information to comply with this requirement.

Sponsors interested in utilizing the fast-track procedure must contact AEMPS prior to submitting their application. This initial contact should be made via email and must include key details such as the planned submission date, the evaluating CEIm, and comprehensive information about the trial, including its title, indication, investigational medicinal product, population, and any additional information that justifies the trial’s eligibility for the accelerated evaluation procedure.

Clinical Trials

Accelerating Clinical Trials Approvals in Spain to Boost Pharmaceutical Research

Once the AEMPS confirms that the trial meets the criteria for the fast-track procedure, the evaluation of the application will commence. The AEMPS commits to completing this evaluation within 26 days from the date of validation, significantly faster than the standard procedure, which typically takes 45 days. In cases where no clarifications are needed, the AEMPS could authorize the trial within a total of 31 days.

When submitting the application, it is essential to include a cover letter indicating that the trial has been accepted into the fast-track procedure by the AEMPS. This acknowledgment ensures that the application is processed under expedited timelines, providing a clear and predictable pathway for the initiation of the trial.

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The introduction of this fast-track evaluation procedure by AEMPS is a strategic move to position Spain as a leading destination for pharmaceutical research and innovation. By reducing the time required to evaluate and authorize clinical trials, AEMPS aims to attract more research investments and facilitate quicker access to innovative treatments for patients. This initiative underscores Spain’s commitment to advancing medical research and addressing critical health challenges through timely and efficient regulatory processes.


Resource: Spanish Agency of Medicines and Medical Devices, May 20, 2024

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