The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

“…Although one of the aims of creating ENCePP was to increase the capacity for large pharmacoepidemiology studies in Europe, the flexible approach adopted by ENCePP for collaborations and the multiple sources of public and private funding do not allow to confirm to date that multicenter studies were initiated with the support of ENCePP. However, feedback received from members suggests that the new culture of collaboration, the common scientific standards, and the common governance principles introduced by the ENCePP have greatly facilitated the establishment of research consortia, for example, in the context of the EMA‐funded studies (Table ) and the European Commission's Seventh Framework Program for drug safety studies (Table ) . Consortia were also created in the context of public‐private partnerships established by the Innovative Medicines Initiative .…”

“…5 Table 2). 3 Consortia were also created in the context of public-private partnerships established by the Innovative Medicines Initiative. 9 In addition, ENCePP members provided occasionally to EMA data that could support drug safety reviews.…”

“…The European Medicines Agency (EMA) has the responsibility for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union (EU) to ensure that their benefits outweigh their risks. While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health‐care professionals and patients, the importance of using the full spectrum of evidence including observational studies has long been acknowledged . The risk management system introduced in the EU in 2006 highlighted the need to build capacity and to facilitate the conduct of multicenter independent postauthorization studies to investigate important risks or missing information in European populations .…”

“…While the roots of medicines' safety monitoring lie in the development of mechanisms for spontaneous reporting of suspected adverse reactions by health-care professionals and patients, the importance of using the full spectrum of evidence including observational studies has long been acknowledged. [1][2][3] The risk management system introduced in the EU in 2006 highlighted the need to build capacity and to facilitate the conduct of multicenter independent postauthorization studies to investigate important risks or missing information in European populations. 4 In March 2006, the EMA contacted more than 90 academic centers in Europe identified through the International Society for Pharmacoepidemiology (ISPE) and national drug regulatory authorities to request information on their expertise and activities in pharmacoepidemiology and pharmacovigilance.…”

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

“…The PRAC ensures its decision-making is supported by robust and timely assessment based on all relevant evidence and drawing on the best available expertise 6 . The PRAC's focus on efficiency, combined with quality, is achieved through improvement of processes based on measurement and analysis and, where appropriate, based on evidence from regulatory sciences 7 .…”