Product information

EU adopts common standard for electronic product information

Regulatory newsRegulatory news

| February 22, 2022 | By Joanne S. Eglovitch

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European regulators announced on Tuesday the adoption of a common electronic product information (ePI) standard for medicines for human use accessible to users and healthcare providers.

The ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement. The EMA published the standard with the European Commission and the Heads of Medicines Agencies (HMAs).

The standard “will pave the way for wider dissemination of unbiased and up-to-date information on all medicines available to patients in the EU via an ever-growing range of electronic channels”, according to the EMA statement. It will harmonize electronic drug information across the EU and is a “step towards better dissemination of information for patients, consumers and healthcare professionals to help them make informed decisions”.

The announcement was accompanied by a summary of comments submitted during a public consultation on a draft ePI standard, as well as comments from regulators. The consultation was opened in June 2021 (RELATED: EMA prepares common EU standard on electronic product informationRegulatory update, June 8, 2021).

Regulators requested comments on three documents: an ePI application program interface (API) specification and a list of API services; a Fast Healthcare Interoperability Resources (FIHR) XML model; and an example of an ePI message in various programming languages.

Seventeen contributors responded to the consultation, including nine comments from the pharmaceutical industry, one from an EU/European Economic Area National Competent Authority and seven “other” contributors. Additional feedback was gleaned from virtual workshops held in July 2021.

The standard has already responded to 17 comments and has been updated in response to 22 comments. A total of 10 comments were not accepted and three were out of scope.

Among the main comments, respondents suggested that the ePI contain more granularity to allow for “advanced use cases”, with regulators responding that the standard had sufficient granularity.

The regulators said that “the granularity of the common EU ePI standard is at a level of [Quality Review of Documents] template headers, and the ePI is annotated with a link to the drug in [Substance, Organization, and Referential master data]. This makes it possible to browse the ePI by section and combine the SPOR API and eAPI to produce business value. »

Still, regulators said there are plans to increase the granularity of information in the ePI and that “part of the future vision for the ePI and the inclusion of additional standardized data in the ePI at the future are achievable”.

Respondents also “expressed a need for functionality to filter ePI data by product, document type, languages, etc. In addition, support is requested for the gradual updating of local copies of ePI data.” Regulators responded that “filtering and incremental updating will be investigated in future work. EMA has already submitted change requests to [Health Level] 7 for language, text and section searches and support for searching and updating local ePIs will be part of future development.

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