The European Medicines Agency has issued a new guidance document covering digital data.
ePI in the EU for all Human Medicines, including both centrally and nationally authorised medicines, will be created using a common electronic standard. The following definition of a common EU electronic standard for ePI is proposed:
A common standard for ePI in the EU refers to the technical features of ePI (including mark-up language, controlled vocabularies and interoperability specifications) agreed by EMA, HMA, NCAs, EC, and representatives of the pharmaceutical industry, patients and HCPs. The standard will be used to generate ePI that fulfils the agreed key principles.
The new document is a joint EMA–HMA–EC collaboration arising from a workshop held at EMA on 28 November 2018 that brought together patients / consumers, Health Care Professionals, the pharmaceutical industry, academia, not-for-profit organisations and regulators to discuss stakeholder needs and concerns, give an overview of the main ePI initiatives ongoing in the EU and decide how to move forward with a common approach.
The outcome of the workshop was a draft proposal for ‘key principles’ for ePI. These key principles were the subject of a 6-month public consultation (from January 31, 2019 until July 31, 2019).
Following the consideration of submissions received during the public consultation, the key principles were updated. They now represent EMA-HMA-EC guidance on ePI and form the basis of follow-up implementation plans for ePI.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
