EU adopts common standard for electronic product information

Regulatory NewsRegulatory News | 22 February 2022 |  By 

European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.
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. EMA released the standard along with the European Commission and Heads of Medicines Agencies (HMA).
The standard will “pave the way for wider dissemination of the unbiased, up-to-date information on all medicines available to patients in the EU through an ever-expanding range of electronic channels,” according to the EMA statement. It will harmonize electronic information on medicines within the EU and is a “step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making.”
Accompanying the announcement was a summary of comments submitted during a public consultation on a draft ePI standard along, with regulators’ feedback. The consultation was opened in June 2021 (RELATED: EMA preps for EU common standard on electronic product information, Regulatory Focus, 8 June 2021).
Regulators sought comments on three documents: an ePI application program interface (API) specification and an API service list; a Fast Healthcare Interoperability Resources (FIHR) XML template; and an ePI sample message in various programming languages.
Seventeen contributors responded to the consultation, including nine comments from the pharmaceutical industry, one from a national competent authority in the EU/European Economic Area, and seven “other” contributors. Additional comments were gleaned during virtual workshops held in July 2021.
The standard already addressed 17 comments and was updated in response to 22 comments. A total of 10 comments were not accepted and three were out of scope.
Among the key comments, respondents suggested that the ePI contain more granularity to enable “advanced use cases,” with regulators responding the standard had sufficient granularity.
Regulators said “the granularity of the EU ePI Common Standard is at a level of [Quality Review of Documents] template headings, and the ePI is annotated with a link to the medicinal product in [Substance, Organization, and Referential master data]. This enables browsing of ePI by section and combining the SPOR API and the eAPI to produce business value.”
Yet regulators said there are plans in the works to increase the granularity of the information in ePI and that “part of the future vision for ePI and inclusion of additional standaridised data in ePI in the future is feasible.”
Respondents also “expressed the need for the functionality to filter ePI data by product, document type, languages etc. In addition, support is requested for incrementally updating local copies of ePI data.” Regulators responded that “filtering and incremental update will be investigated in future work. EMA has already submitted change requests to [Health Level] 7  for searches on language, text and by section and support to searches and update of local ePI will be part of future development.
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