Good Clinical Practice Standards in Spain – AEMPS Overview

Regulatory Framework

Good Clinical Practice (GCP) in Spain is governed by EU Regulation (EU) No 536/2014 on clinical trials of medicinal products for human use (fully applicable since 31 January 2022) and national implementing legislation, including Royal Decree 1090/2015 (as amended). AEMPS acts as the competent authority responsible for authorisation, supervision, inspection, and enforcement of GCP compliance for all interventional clinical trials conducted in Spain. The core principles ensure protection of rights, safety, dignity, and well-being of trial subjects while producing credible clinical trial data. Buena Práctica Clínica - AEMPS

Key GCP Requirements

• Trial Authorisation: All interventional trials require prior authorisation from AEMPS and favourable opinion from an accredited Research Ethics Committee (REC). Applications are submitted via the EU CTIS portal.
• Investigator and Site Responsibilities: Principal investigators must be qualified, experienced, and adequately resourced. Sites must have appropriate facilities, staff, and procedures.
• Informed Consent: Written, dated, and signed consent from each participant (or legal representative) is mandatory, with clear information provided in understandable language.
• Data Management and Integrity: Accurate recording, handling, and storage of data; source data verification; electronic systems compliant with Annex 11 of EU GMP guidelines.
• Safety Reporting: Immediate reporting of serious adverse events and suspected unexpected serious adverse reactions (SUSARs) to AEMPS and other competent authorities within required timelines.
• Quality Assurance: Sponsors must implement risk-based quality management, conduct monitoring, and maintain audit trails.

Inspections and Compliance

AEMPS conducts routine and for-cause GCP inspections of trial sites, sponsors, contract research organisations (CROs), and laboratories. Inspections assess adherence to the approved protocol, GCP principles, and applicable regulations. Findings are classified (critical, major, minor) and may lead to corrective and preventive action plans, trial suspension, or withdrawal of authorisation in severe cases.

Responsibilities of Stakeholders

• Sponsors: Ensure overall trial quality, safety monitoring, data management, and reporting; maintain trial master file (TMF).
• Investigators: Conduct the trial according to protocol, protect subjects, and provide accurate data.
• Ethics Committees: Evaluate scientific and ethical aspects; provide continuous oversight.
• AEMPS: Authorises trials, monitors compliance, investigates complaints, and coordinates with EU partners.

Practical Guidance and Resources

AEMPS provides detailed guidance documents, including national recommendations on specific GCP topics (e.g., risk-based monitoring, electronic informed consent, decentralised trials), inspection checklists, and FAQs. Sponsors and investigators are encouraged to consult these resources and contact AEMPS for pre-submission advice. Compliance with GCP is essential for acceptance of Spanish trial data in EU marketing authorisation dossiers.

This robust framework safeguards trial participants while facilitating high-quality clinical research in Spain, contributing to the development of safe and effective medicines. Comprehensive information, forms, guidance documents, and contact details are available on the AEMPS Good Clinical Practice dedicated page. Buena Práctica Clínica - AEMPS