Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019

29 November 2019

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table.

Information on all topics discussed by the PRAC is available in the agenda below. 

Agenda

Agenda - PRAC draft agenda of meeting 25-28 November 2019

Draft Reference Number: EMA/PRAC/640603/2019

PRAC statistics: December 2019

PRAC statistics: December 2019

Glossary:

• Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under Periodic safety update reports: questions and answers.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk-management plans.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS).
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found underReferral procedures.

Ongoing referrals

Procedure	Status	Update
Article-31 procedure: Cyproterone-containing medicinal products	Under evaluation	PRAC continued its assessment.
Article-31 procedure: Estradiol-containing (0.01% w/w) medicinal products for topical use	PRAC recommendation issued on 3 October 2019	Following the PRAC’s recommendation of 3 October 2019, one of the marketing authorisation holders involved with this review has requested a re-examination. Upon receipt of the grounds for the request, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 13-16 January 2020.
Article-20 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products	Under evaluation	PRAC adopted a list of outstanding issues (LoOI).
Article-31 procedure: Leuprorelin-containing depot medicinal products	Under evaluation	PRAC continued its assessment.
Article-20 procedure: Picato	Under evaluation	PRAC continued its assessment.