ENCePP Guide on Methodological Standards in Pharmacoepidemiology
The Guide on Methodological Standards in Pharmacoepidemiology is a longstanding cornerstone of the ENCePP toolkit, as described in Strengthening Pharmacoepidemiology in a Changing Research Environment: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) (Pharmacoepidemiol Drug Saf. 2025;34:e70263).
Since its first edition in 2012, the Guide has provided practical methodological guidance, bringing together international recommendations, key guidelines, scientific literature, and good practice considerations where gaps have been identified.
As the use of real-world data (RWD) in studies on the utilisation, safety and effectiveness of medicinal products is expanding, so has the body of methodological guidance, including but not limited to the Reflection paper on use of RWD in non-interventional studies, ICH M14, Pharmacoepidemiology and Drug Safety’s Core Concepts, guidance documents from international regulators, the International Society for Pharmacoepidemiology (ISPE), the Professional Society for Health Economics and Outcomes Research (ISPOR), the International Society of Pharmacovigilance (ISoP), and peer-reviewed academic and pharmaceutical industry literature.
As these standards continue to rapidly evolve, the Guide has moved to a living resource to continue supporting high-quality pharmacoepidemiological research and the generation of reliable real-world evidence (RWE), serving a broad group of stakeholders including researchers, regulators, healthcare professionals, and marketing authorisation holders and applicants in Europe and globally.
The last full revision, dated July 2023, is available on this page. The date of the most recent update is displayed at the top of each chapter. Where no date is indicated, the chapter has not yet been revised and the content remains unchanged from the previous full revision.
The Guide is managed by a dedicated Working Group which identifies areas for update and oversees the revision of individual chapters, under the oversight of the ENCePP Steering Group.
The ENCePP network and the wider pharmacoepidemiological research community are encouraged to share with the ENCePP_Secretariat
ema [dot] europa [dot] eu (ENCePP Secretariat) suggestions for improvement and proposals for updates of specific chapters.
