AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines.
In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for validation and evaluation of applications for authorization of trials submitted in the European Union. However, this procedure will allow the deadlines to be reduced for studies that meet the following criteria:
- Be a phase I clinical trial.
- Research advanced therapy medications.
- Study seriously debilitating diseases or diseases that endanger the patient’s life and have no therapeutic alternative.
- Submit through the EU clinical trials database CTIS ( Clinical Trial Information System )only in Spain.
In addition, the Drug Research Ethics Committee (CEIm) selected by the promoter must be one of the CEIm adhered to the fast-track procedure . The contact details of these CEIm are available in the Directory of CEIm accredited in Spain .
- Those interested in taking advantage of this procedure must contact the AEMPS prior to submitting the application by writing to aecaem@aemps.es . This email will indicate the expected date of shipment, the evaluating CEIm and the characteristics of the trial: title, indication, investigational drug, population and additional information that justifies compliance with the requirements to access the accelerated evaluation procedure.
- If you meet the requirements, once you have the fast-track acceptability approval from the AEMPS, the application will be evaluated within 26 days from validation . If it is not necessary for the agency to seek any clarification, a trial could be authorized by the AEMPS within a period of 31 days.
- When submitting an application, it must be indicated in the accompanying letter that adherence to the fast-track procedure has been accepted by the AEMPS.
Source: AEMPS