PRAC: Pharmacovigilance Risk Assessment Committee
The PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.
The Pharmacovigilance Risk Assessment Committee was created by the 2012 pharmacovigilance legislation and is established by Article 56(1)(aa) of Regulation (EC) No 726/2004, with its composition in Article 61a. Each Member State appoints a member and an alternate, the Commission appoints six independent scientific experts, and one representative each of healthcare professionals and patients' organisations sit as full members. Iceland and Norway take part. The committee meets monthly at EMA and publishes its agenda, highlights and minutes.
The PRAC covers all aspects of risk management for medicines authorised in the EU, whether centrally or nationally. It assesses risk management plans with new applications, leads the PSUR single assessment, assesses protocols and results of post-authorisation safety studies, runs signal management and recommends action on validated signals, and performs the scientific assessment in safety referrals under Articles 31 and 107i of Directive 2001/83/EC and Article 20 of Regulation (EC) No 726/2004. Its output is a recommendation, which goes to the CHMP for centrally authorised products or to the CMDh where only nationally authorised products are involved.
For holders the committee's decisions arrive through several channels: the published signal list with requests to submit data, PSUSA outcomes that require product information updates, referral conclusions, and recommendations on direct healthcare professional communications, whose text and distribution plan the committee reviews. The PRAC rapporteur for a substance leads the assessment, and holders deal with the rapporteur's questions on the timetable the procedure sets.
What goes wrong: safety teams that monitor the minutes of the CHMP but not the PRAC, and miss a signal request addressed to all holders of a substance; late or incomplete responses to a signal request, which are visible in the published outcome; and assuming a PRAC recommendation is not yet actionable, when the CHMP opinion or CMDh position that follows is usually a matter of weeks and the implementation deadline runs from it. The committee also assesses the protocols and final reports of imposed post-authorisation safety studies, so a holder with such a study has a direct relationship with it between PSUR cycles and should plan submissions around its meeting dates.
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Pharmacovigilance teams watch PRAC agendas, signal lists and recommendations for your substances with Alerts.
Related terms
- PSUSA: PSUR single assessmentA PSUSA is the single EU assessment of all periodic safety update reports for one active substance, led by the PRAC and binding on every holder.
- Signal detection: identifying new safety information from pharmacovigilance dataSignal detection is the process of finding information that suggests a new or changed causal link between a medicine and an adverse event.
- RMP: risk management planA risk management plan (RMP) describes a medicine's known and potential risks, how they will be studied and minimised, and forms part of the authorisation.
- CHMP: Committee for Medicinal Products for Human UseThe CHMP is the EMA committee that assesses centralised applications and referrals for human medicines and adopts the opinions behind Commission decisions.
- Article 31 referral: referral in the interest of the UnionAn Article 31 referral is an EU-level assessment of a medicine or class of medicines where the interests of the Union are involved, usually on safety.
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