May 31 2024
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26 days to evaluate your clinical trial thanks to AEMPS' fast-track assessment
The Spanish Agency for Medicines and Health Products (AEMPS) has implemented a new accelerated assessment procedure for certain clinical trials. This initiative aims to make Spain a more attractive environment for innovative drug research. Below, we explain which trials can take advantage of this fast-track process that reduces the evaluation time from 45 to 26 days
By Sermes Cro
AEMPS has launched a procedure that allows for the accelerated evaluation of clinical trials, significantly reducing the usual authorization times. This procedure is aimed at clinical trials that meet the following characteristics:
Being a phase I clinical trial.
Investigating advanced therapy medicinal products.
Studying diseases that are severely debilitating or life-threatening with no therapeutic alternatives.
Submitted through the European Clinical Trial Information System (CTIS) database exclusively in Spain.
26 days for evaluation compared to the usual 45 days
The main benefit of this procedure is the reduction in evaluation time. While the usual procedure can take up to 45 days, the accelerated assessment allows for a response in just 26 days from the validation of the application. In some cases, authorization can be granted within 31 days if no additional clarifications are required.
Steps to benefit from the accelerated assessment procedure
To benefit from this procedure, clinical trial sponsors must follow these steps:
Initial Contact with AEMPS: Before submitting the application, it is necessary to contact AEMPS by sending an email to aecaem@aemps.es. This email must include the anticipated submission date, the evaluating CEIm, and the characteristics of the trial, such as title, indication, investigational drug, population, and any additional information that justifies compliance with the requirements.
Application for Assessment: Once the fast-track procedure acceptability is confirmed by AEMPS, the assessment application must be submitted, indicating in the cover letter that the fast-track procedure has been accepted.
Accelerated Evaluation: The application will be evaluated within 26 days from its validation. If no clarifications are required, AEMPS may issue its authorization within approximately 31 days.
Sermes CRO, experts in Clinical Regulation and leaders in CTIS
At Sermes CRO, we have a specialized unit exclusively dedicated to the submission of clinical trials through CTIS, the European clinical trial management platform. In addition to being part of the EMA working group that developed the platform, we were the first Spanish CRO to submit a clinical trial through CTIS. To date, we have been responsible for the submission of 8% of the commercial studies managed within this European clinical trial database.
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