Sabine Brosch, Pharmacovigilance and Inspections, European Medicines Agency, United Kingdom



In 2010 the EU announced major changes to pharmacovigilance requirements, which became effective in 2012 and beyond (1) focusing on a risk based approach towards the safety monitoring of medicines, an increase in the proactivity and planning of pharmacovigilance activities, enhanced transparency and better provision of information to healthcare professionals and the public as well as a reduction of the duplication of efforts for both regulators and pharmaceutical industry. Highlights of the new pharmacovigilance legislation are summarized as follows:
Across the EU patients have been empowered to report adverse reactions allowing for their more active involvement in the safety monitoring of medicines. An inverted black triangle has been introduced as a symbol for biologics and for medicines containing a new active substance or being subject to other additional monitoring criteria. For these medicines, a standard text is being introduced in Patient Leaflets and Summary of Product Characteristics encouraging healthcare professionals and patients to report adverse reactions in accordance with the national reporting system.
EudraVigilance (EV) – the European database for adverse reaction reports (2) is being enhanced focusing on high quality of data, the support of the new signal management process in the EU and providing public access to adverse reaction data.
The new Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, while taking the therapeutic effect of the medicine into account. It also has responsibility for the design and evaluation of post-authorisation safety studies and pharmacovigilance audits.
EMA developed an initiative termed ‘best evidence to support regulatory decision-making’ for the timely gathering of scientific evidence to inform regulatory decision-making. Sources for such evidence include a liaison with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) (3) Pharmaceutical companies have to submit a risk-management plan (RMP) at the time of application for a marketing authorisation or as part of a significant change to an existing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. EU PROTECT (4) innovative methods for benefit-risk (BR) assessment of medicines. The Periodic Benefit Risk Evaluation Report (PBRER) (5) of the safety specification. A Union reference date and the frequency of submission have been defined to facilitate a single assessment of a PBRER in the EU.

Reference:

1 REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 December 2010
DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15
December 2010
COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012
Good Pharmacovigilance Practices (GVP) modules http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp

2 http://www.adrreports.eu

3 http://www.encepp.eu

4 www.imi-protect.eu

5 Periodic Safety Update Report (PSUR) referred to in ICH-E2C(R2) guideline as PBRER
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_Step4.pdf

25Oct