Electronic Product Information (ePI) for EU medicines An agency of - - PowerPoint PPT Presentation

An agency of the European Union

Electronic Product Information (ePI) for EU medicines

Classified as public by the European Medicines Agency

ePI chronology

1

EC report mandated by Article 59(4) Directive 2001/83/EC on shortcomings in the PI

March 2017

EMA action plan

November 2017

ePI mapping survey and stakeholder engagement

Throughout 2018

Stakeholder workshop on landscape and draft key principles

November 2018

Public consultation

• n draft key

principles

January- June 2019

Finalised key principles and roadmap adopted by HMA and EMA MB

November- December 2019 January 2020

Key principles published

Classified as public by the European Medicines Agency

2

ePI is authorised, statutory product information for medicines (i.e. summary

• f 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.

Definitions

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.

Classified as public by the European Medicines Agency

3

List of her medicines ePI in phone app Does not remember how to take asthma medicine Goes to ‘How to take your medicine’ to downloadable video Receives alert when ePI updated e.g. new safety information Links to other material

• Educational material
• Lay summaries
• More technical material

Use cases

Patient

Classified as public by the European Medicines Agency

4

Checks renewal of prescription for chronic condition, new side effect in prescribing system Approves renewal with:

• message in the personal

health record of patient

• contact with patient
• Pregnancy planning
• Lactose intolerance
• Hay fever OTC without drowsiness

Treatment decision Targeted ePI search

Use cases

Healthcare professional

Classified as public by the European Medicines Agency

5

ePI key principles

ePI and EU common standard definitions Expansion of access to information on medicines Accessibility to users with diverse abilities Creation of efficiencies for regulatory systems Complementarity to paper package leaflet

1 2 3 4 5

Classified as public by the European Medicines Agency

6

ePI key principles

Open access to regulator-approved information Data protection Flexibility in implementation Support for multilingual PI Interoperability with EU and global initiatives

6 7 8 9 10

Classified as public by the European Medicines Agency

7

ePI key principles

Classified as public by the European Medicines Agency

Public consultation — stakeholder profile

8

31 January to 31 July

2 4 4 5 8 8 8 10 22

5 10 15 20 25

71

submissions comprising >500 comments

Member

• f the

public Academic EU/EEA national competent authority Patient/ consumer Patient/ consumer

• rganisation

Healthcare professional Healthcare professional

• rganisation

Other Pharmaceutical industry

Classified as public by the European Medicines Agency

Public consultation — main points & sentiment

9

17% 8% 75%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Positive Negative Neutral

• Appetite for widening scope of ePI

(e.g. photos of medicines, risk minimisation material, DHPCs)

• Strong wish to also work on PI content
• New key principle on efficiencies in

regulatory processes

• Strong views on both sides on principle

that ePI complements paper High interest and encouraging support for initiative with just ~8% negative comments

Classified as public by the European Medicines Agency

EU Roadmap — implementation on basis of key principles

10 10

ePI set-up project Pilot phase (EMA & pioneer NCAs) Transition to implementation 1-2 year 2 years Timeline dependent on pilot outcome

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

Ongoing consultation with patient and HCP representatives

Classified as public by the European Medicines Agency

Any questions?

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

Further information

Follow us on @EMA_News #ePI4Medicines