prac

Prac is a term that may refer to different concepts, but its most prominent use is as an acronym for the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). PRAC was established as part of EU pharmacovigilance reforms to oversee the safety evaluation of medicines for human use in the European Union. Its core remit includes assessing signals of adverse effects, monitoring the risk-benefit balance of medicines, and developing risk minimization measures.

When safety concerns arise, PRAC conducts analyses, prepares safety recommendations, and provides opinions that inform regulatory actions by the European Commission and national authorities. The committee’s work can lead to label changes, usage restrictions, post-authorization studies, or, in extreme cases, withdrawal of a medicine from the market. PRAC’s opinions help shape decisions taken within the EMA framework and influence subsequent actions by member states.

Composition and procedure are oriented toward collaboration among EU member states, with involvement from independent experts and EMA staff. PRAC operates through regular meetings and formal procedures, drawing on pharmacovigilance data, clinical assessments, and risk communication strategies. Its work is situated within the broader EMA system for safeguarding public health by ensuring that medicines on the EU market maintain an acceptable safety profile.

In other contexts, prac can appear as a word-form element in several languages. For example, in Polish, prac- is a morphological stem found in verbs such as pracować (to work) and is not used as a standalone word. The term may also appear as an acronym for entities unrelated to pharmacovigilance.