ABSTRACT
The Pharmacovigilance Risk Assessment Committee (PRAC) was established in 2012, following the implementation of a new comprehensive legislation in the EU. The committee is composed of members from the 27 member states, Norway and Iceland, additional experts from universities across Europe as well as health care and patient representatives. The mandate covers all aspects of risk management pre- and post-authorization, benefit/risk assessments and organization of public hearings. The toolkit comprises referrals, periodic safety update reports, risk management plans, signals, post-authorization safety studies, post-authorization efficacy studies and additional monitoring. The PRAC recommendations are forwarded to the CMD(h) and CHMP or formal adoption. With the emergence of the pandemic, the existing guidance has been supplemented with a pharmacovigilance plan aiming at effective data collection, detection and assessment of safety data. Additional guidance regarding the development of risk management plans had been issued. PRAC has contributed significantly to the work in the pre- and postauthorization phase, having provided advice regarding the risk management plans and having assessed numerous signals, safety reports and PASS protocols for the COVID-19 vaccines. All done in accordance with the basic PRAC principles of risk-based approach, involvement and transparency.