Transparency of Safety Monitoring System
Publication of PRAC agenda, minutes, signal recommendations, referral outcomes, WS PSURs, Publication of DHPCs
New legislation introduced in July 2012 included a strong commitment to openness and transparency in the European medicines safety-monitoring system. This has resulted in much more information being made publically available and allows us to build on our efforts in recent years to provide the public with more information about the safety of medicines.
A new scientific committee at the European Medicines Agency (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC), was also established under this new legislation. The PRAC meet on a monthly basis and its mandate covers activities relating to the assessment and monitoring of safety issues for human medicines. This includes all aspects of the risk management of the use of medicinal products including the detection, assessment, minimisation and communication relating to the risk of adverse reactions. The PRAC advises the Committee on Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh).
Agendas and Minutes of the PRAC meetings are published here on the website of the European Medicines Agency and a link to highlights of the meeting is published on the HPRA website. For EU-wide safety reviews, more information than ever before is provided at the beginning of the safety review with updates provided as needed and comprehensive details on the outcome published following conclusion of the review. The PRAC also evaluates potential safety signals and the recommendations are published on the EMA website at the following link.
As part of this drive towards making information on medicines more accessible to the public, public summaries of Risk management Plans will be published on the HPRA and EMA websites in the future. A Risk Management Plan (RMP) is a document which describes what we currently know about the safety and efficacy of a medicine. A summary of the RMP is written in lay language and intended for healthcare professionals, patients and consumers. Details of how safety issues are being monitored and activities which aim to minimise risks will also be outlined.
Other documents available on the HPRA website include Direct Healthcare Professional Communications (DHPC). When it is considered that healthcare professionals need to be informed about a safety issue with a medicine the HPRA may request the company who market that medicine to send a DHPC. The content of the letter and the list of recipients will be agreed with the HPRA. All DHPCs are published on the HPRA website under Latest updates shortly after they are distributed to healthcare professionals.
A Periodic Safety Update Report (PSUR) is a report providing an evaluation of the benefit-risk balance of a medicine based on worldwide safety experience at defined time points post-authorisation. Assessment of PSURs has been harmonised within the EU for certain products within a worksharing arrangement. Summaries of the PSUR evaluation carried out by the lead member state within the EU are now published on the website
of the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh).