[The European pharmacovigilance: regulatory aspects].

Area of Science:

• Pharmacovigilance
• Drug Safety
• European Regulatory Affairs

Background:

• The European pharmacovigilance system was established in 1995 concurrently with the European Agency for the Evaluation of Medicinal Products (EMEA).
• Initial system design featured decentralized safety data collection and validation by member states, with centralized evaluation by EMEA committees.

Purpose of the Study:

• To describe the evolution and structure of the European pharmacovigilance system.
• To highlight the transition towards a more interactive and cooperative safety data management approach.

Main Methods:

• Review of the historical development of the European pharmacovigilance framework.
• Analysis of the organizational structure, including decentralized data collection and centralized evaluation processes.

Main Results:

• The system initiated in 1995 involved the EMEA and new European registration procedures.
• A decentralized data collection and validation model was implemented, with centralized evaluation by the Committee for Proprietary Medicinal Products (CPMP) and its Pharmacovigilance Working Party.
• The system evolved into an interactive model emphasizing cooperation among member states for common safety concern management.

Conclusions:

• The European pharmacovigilance system has undergone significant development since its inception.
• The current interactive system fosters collaboration among member states for effective drug safety monitoring and management.