Electronic Product Information (ePI) for EU medicines An agency of the European Union
ePI chronology Throughout November- 2018 December 2019 ePI mapping November survey and Finalised key January- 2017 March stakeholder principles and June 2019 2017 January November engagement roadmap EMA action 2020 2018 adopted by EC report mandated Public plan HMA and EMA by Article 59(4) consultation Stakeholder Key MB Directive on draft key workshop on principles 2001/83/EC on principles landscape and published shortcomings in the draft key PI principles 1 Classified as public by the European Medicines Agency
Definitions ePI is authorised, statutory product information for medicines (i.e. summary of product characteristics, package leaflet and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e- platforms and print. A common EU electronic standard for ePI refers to the technical features (including mark-up language, controlled vocabularies and interoperability specifications) agreed by regulators and stakeholders. The common standard will be used to generate ePI. 2 Classified as public by the European Medicines Agency
Use cases Patient List of her medicines Links to other material Receives alert when ePI ePI in phone app updated e.g. new safety information Does not remember how to • Educational material take asthma medicine • Lay summaries • More technical material Goes to ‘How to take your medicine’ to downloadable video 3 Classified as public by the European Medicines Agency
Use cases Healthcare professional Approves renewal with: Checks renewal of prescription • message in the personal for chronic condition, new side health record of patient effect in prescribing system • contact with patient • Pregnancy planning Targeted ePI Treatment • Lactose intolerance search decision • Hay fever OTC without drowsiness 4 Classified as public by the European Medicines Agency
ePI key principles ePI and EU common standard definitions 1 Expansion of access to information on medicines 2 3 Accessibility to users with diverse abilities 4 Creation of efficiencies for regulatory systems 5 Complementarity to paper package leaflet 5 Classified as public by the European Medicines Agency
ePI key principles Open access to regulator-approved information 6 Data protection 7 8 Flexibility in implementation 9 Support for multilingual PI 10 Interoperability with EU and global initiatives 6 Classified as public by the European Medicines Agency
ePI key principles 7 Classified as public by the European Medicines Agency
Public consultation — stakeholder profile 31 January to 31 July 71 25 22 20 15 submissions 10 comprising 8 8 8 10 5 4 4 >500 5 2 comments 0 Healthcare Member Academic EU/EEA Patient/ Patient/ Healthcare Other Pharmaceutical professional of the national consumer consumer professional industry public competent organisation organisation authority 8 Classified as public by the European Medicines Agency
Public consultation — main points & sentiment • Appetite for widening scope of ePI 75% 80% (e.g. photos of medicines, risk 70% minimisation material, DHPCs) 60% 50% • Strong wish to also work on PI content 40% 30% 17% • New key principle on efficiencies in 20% 8% regulatory processes 10% 0% • Strong views on both sides on principle Positive Negative Neutral that ePI complements paper High interest and encouraging support for initiative with just ~8% negative comments 9 Classified as public by the European Medicines Agency
EU Roadmap — implementation on basis of key principles ePI set up project defines common standard and provides tools needed for a pilot phase Pilot by EMA and some pioneer NCAs tests ePI from end-to-end and assesses impact on current processes ePI set-up project Pilot phase (EMA & pioneer NCAs) Transition to implementation 1-2 year 2 years Timeline dependent on pilot outcome Ongoing consultation with patient and HCP representatives 10 10 Classified as public by the European Medicines Agency
Any questions? Further information Juan.Garcia@ema.europa.eu See websites for contact details European Medicines Agency www.ema.europa.eu Heads of Medicines Agencies www.hma.eu European Commission www.ec.europa.eu Follow us on @EMA_News #ePI4Medicines Classified as public by the European Medicines Agency
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