EMA publishes first electronic Product Information as pilot progresses
In 2022, the European Commission, Heads of Medicines Agencies and EMA established a common standard for electronic Product Information, or ePI, an electronic representation of information patients usually receive in paper format along with their medicines. EMA is running a one-year pilot for 25 products, publishing the first ePIs for seven medicines last week.
Background on electronic Product Information
- The European Commission (EC) has flagged the move to an electronic format for some product information as an area of improvement. A 2017 European Commission report ( EMA presentation) highlighted various areas for improvement of product information (e.g., readability of package leaflet, patient engagement). The report recognized the potential for an electronic format for Product Information (i.e., Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. At that time, though, EMA proposed that electronic information should be complementary and not replace printed information, proposing the development of tools for informing patients and healthcare professionals of changes.
- The summary of Product Characteristics (SmPC) and the Package Leaflet (PL) are the main target for digitalization. “ Product information” includes “documents providing officially approved information for healthcare professionals and patients on a medicine.” The Summary of Product Characteristics (SmPC) is “a document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively.” (See also Article 11 of Directive 2001/83/EC.) The Package Leaflet (PL, also sometimes called Package Information Leaflet or PIL) is included in medicine packaging and contains information for end-users, usually patients (see also Article 59 of Directive 2001/83/EC).
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) has suggested that replacing certain paper product information with electronic versions has benefits for healthcare providers, regulatory agencies and patients. The trade association argued in a report earlier this year that patients and healthcare professionals would benefit from electronic versions that can be tailored to their needs and updated frequently; the electronic format also supports accessibility, health literacy and informed decision making. ePI would also be available in multiple languages. Regulatory advantages of the electronic format include mitigating medicines shortages and increasing supply chain flexibility, as well as, increasing regulatory efficiency and giving insight into trends in medicines. For sponsors, it also decreases the cost of producing und updating paper versions of the PLs. [See AgencyIQ’s analysis of the EFPIA Evidence MIX report.]
- The European Medicines Regulatory Network adopted a Common Standard for electronic Product information, paving the way for wider implementation. Electronic publication of product information allows for immediate, harmonized updates of product information, and “is a step towards improved delivery of information for patients, consumers and healthcare professionals to aid their informed decision-making,” according to the EMA. Product information can be updated as soon as new information becomes available. The EMA suggests that the harmonized structure could also allow for personalization of product information according to patient needs and address accessibility requirements for patients with disabilities. [See AgencyIQ’s analysis of the Common Standard for ePI].
- As part of the Common Standard, “ Electronic Product Information (ePI)” is defined as the “authorised, statutory product information for EU medicines (the summary of product characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients / consumers]) in a semi-structured format created using the EU Common Standard. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.”
- Separately, a 2022 hospital trade group survey found that most hospital pharmacists (78%) already use product information in electronic format and rely on local health authorities or compendia for information. Only 20% of respondents indicated that their facility does not use digital product, and only 14% of patients directly receive a paper copy of the package leaflet in hospitals. The responding hospital pharmacists indicated that over half (55%) of patients do not receive package leaflets and information is orally shared with patients in 21% of cases. Most survey respondents (61%) noted that a digital format for product information would allow for faster and easier access to that information, but the currently available hospital infrastructure may not support accessibility. [See AgencyIQ’s analysis of the report.]
As part of a pilot, the ePIs for the first seven products were published last week
- The EMA, along with other EU national competent authorities, are piloting ePIs for 25 products. The pilot, launched in July 2023, will run for 12 months; four countries – Denmark, the Netherlands, Spain, and Sweden – are participating. Access to the ePIs is through the Product Lifecycle Management Portal or through the “ application programming interface (API) tool.” ePIs will be presented as bundles consisting of the SmPC, Annex II document, labeling and the package leaflet. Sponsors can access the ePI authoring tool through the Product Lifecycle Management Portal. Procedural guidance for the national and centralized authorization procedures, ePI user guide, ePI registration guide and a ten-minute video tour are available.
- Of the seven products with the first published ePIs, just one, Imatinib Teva, was authorized through the centralized procedure with an E.U.-wide authorization. Of the remaining products, two are authorized in Sweden, two in the Netherlands, and one each in Denmark and Spain. are nationally authorized in one of the four participating countries. Products included are nationally authorized by regulatory authorities in Denmark, the Netherlands, Spain and Sweden (2 products). The ePI is only available in the national language of the country where it is authorized. The information is available in the official E.U. languages for products approved through the centralized procedure.
- The EMA reminded stakeholders in the frequently asked questions that the “provision of ePI does not negate the requirement to submit product information annexes in eCTD.” The ePI can be created online and then exported to Word. However, EMA noted in an update that a Word or PDF document can’t be uploaded to create the ePI, which needs to be developed in the portal. It is the sponsor’s responsibility to ensure that the ePI is identical to the approved product information by the end of the pilot, when the ePI will be assessed by the regulator. If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.
- There are some known issues when using the system to create the ePI, which mostly relate to formatting. Additionally, subsections not included in the Quality Review of Documents (QRD) template added in the ePI can’t be reordered. As a workaround, regulators suggest including all text and subsections in the parent section and then manually formatting subsection headers. Also, the names of subsections in the tree navigation of the ePI editor and in the preview might display in the wrong language, so they have to be fixed manually. Other known issues relate to line spacing, certain language characters, bullet points and image display; suggested workaround are suggested for these as well.
Meanwhile, Sweden has launched its own ePI project to support implementation
- The Swedish Medical Products Agency (MPA) developed a proof-of-concept model in 2022. This included an extensible markup language (XML) template that could be adapted to work with the editor tool used to create electronic structured SmPCs. Content created in the editor tool is readable by machines and humans, and ties defined data elements to information from other health data sources and metadata, to enable data extraction.
- The concept was developed in a hands-on March 2023 workshop where members of industry participated in building the proof-of-concept editor tool. According to the MPA, workshop participants concluded that the tool makes it easier to structure, standardize, and harmonize product information. Additional development objectives for the tool include include migration of structured text from other sources into the tool, prompts to avoid duplicationand to highlight omitted information or structure, and the ability to tailor filters according to user need.
- The Swedish platform doesn’t replace the E.U. platform, but expertise gained with the national project will be implemented in the EMA project. The MPA states that it plans to work on both the Swedish platform and with the EMA on the E.U. platform in the coming years. However, once finalized, the EMA tool and portal will be used for the creation, approval and publishing of all product information irrespective of the procedure type.
- The Swedish regulator envisages various uses for the structured data. The structured information will be available on the MPA website as open-source data. The package leaflet will remain in paper form (at least for now). For example, patients could research an over-the-counter medication for various aspects such as possible intolerances or use in specific indications.
- Standardized ePI would harmonize and align the content of product information across the E.U. for all authorization procedures. Information for the various product information documents would follow one template, harmonizing where and how information is presented. This should make things easier for industry by simplifying processes for providing the product information and making requirements predictable. It may impact patients and healthcare providers less if they only look at their national product information, at least for countries that are not also heading toward ePI.
- Updating the ePI would become a more time- and cost-efficient process. The information to be updated or changed would only need to be changed online in the system, without the need for additional translations, reprinting of product information for new packages, or the potential need to destroy packages with the older information. This would make the update process faster, since it would only depend on input and approval timelines. Personnel costs could be reduced, as would resources formerly used to print physical copies of new product information.
- However, there are also some challenges, particularly relating to information technology capabilities. The EAHP report highlighted the need to consider the “structural preconditions of hospitals in Europe regarding technical equipment.” The same would be true for information technology capabilities at national regulators and within the pharmaceutical industry. While medium to large companies may be able to implement the necessary infrastructure, small companies may not have the resources. Conversion of large portfolios of medicines may also take considerable time. EMA said that it would take into consideration that converting all product information into ePIs will be challenging for companies with large portfolios, and will account for that in timelines for conversions.
- Patient uptake could also pose a hurdle. The EAHMP report also indicated that patients could benefit from the implementation of ePI, since only about 55% currently receive the paper copy of product information according to the survey. Availability online would provide access as needed. However, internet access through smartphones is widespread but not universal. According to a study, only 79% and 76% of people have smartphones in Poland and Hungary respectively. In those countries, only 81% of adults access the internet, which would still leave about a fifth or more of the population without access to ePI if it becomes the only available form.
- Realistically, paper product information could be phased out by 2030. An EFPIA report noted that 11 of 15 responding companies thought that 2030 was a realistic goal for completely replacing paper-based product information with ePIs, although only three thought a 2025 date was achievable. Remaining challenges include the current variable acceptance, potential need for legislative changes, need for a harmonized approach across the E.U., and supply chain readiness. A multi-disciplinary approach and agile staggered phase-out will be needed to ensure efficient implementation of ePI.
- The EMA has been providing regular progress updates. The use of ePI provides many advantages including immediate harmonized product information updates. While the wider implementation of ePI use is still several years in the future, change is coming nonetheless.
- According to a December 2022 update, EMA is planning a to start an implementation phase in 2024. Presumably, that phase would start after completion of the pilot and potentially its evaluation. The regulator further notes that “ePI will be rolled out for NCAs [national competent authorities] in a planned way, depending on readiness and resources.” The EMA would initially implement the ePI for products approved through the centralized procedure and among early adopters from national agencies (e.g., Sweden, Denmark).
Key Documents and Dates
- Press release – First electronic product information (ePI) published for selected human medicines, November 8, 2023
- EMA website – Electronic Product Information (ePI)