Clinical trials with medicines for human use

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Last update: February 15th 2023
From January 31st 2023 all new clinical trial applications must be submitted via European system CTIS.

Every clinical trial application processed through CTIS will have a valid final decision that the sponsor will receive via CTIS in accordance with Regulation 536/2014, without the requirement of additional national resolutions. In any case, an Appeal for Reconsideration may be brought to Head of the Spanish Agency of Medicines and Medical Devices within one month, according to Law 39/2015 (articles 123 and 124), October 1st, on the Common Administrative Procedure of Public Administration, or to interpose Contentious-Administrative Appeal to Contentious-Administrative Madrid Central Court, within two months from the next day of the reception of the decision notification, according to Contentious-Administrative Jurisdiction Regulation of July 13th 1998, without prejudice to any other appeal that may be interposed.

A clinical trial with medicines for human use is an investigation in relation to humans, in order to study drug safety and efficacy. The purpose of these studies is to get relevant data that prove a positive benefit/risk profile for a certain therapy so that marketing authorization can be requested.

There are several stages during clinical investigation where study population progressively increase:

  • Phase I: a few participants (tens) that can be healthy volunteers, to confirm that drug administration is safe.
  • Phase II: efficacy analysis in a 200-300 people study population, while safety for phase one doses is still monitored.
  • Phase III: drug efficacy confirmation among thousands of participants so that data can be obtained to get a marketing authorization.
  • Phase IV: long-term studies with authorized medicines to study rare adverse drug reactions or additional benefits.

The Spanish Agency for Medicines and Medical Devices (AEMPS) is the national competent authority to grant an authorisation for a clinical trial with medicines for human use. Nevertheless, assessment of both scientific and ethic aspects is done by AEMPS and Ethics Committees for Investigation with medicinal products (CEIm) on a coordinated procedure.

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