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The leaflet is an integral part of any medicine. Moreover,ย according to the EU Legislation, it is obligatory to include a package leaflet with all medicinal products, unless all the information required is directly conveyed on the packaging. However, the pharma supply chain and its essential units are undergoing transformation due to digital transformation, and the leaflets are no exception.
From paper to digital leaflets, the industry found a solution that makes patient information more inclusive, reducing the negative impact on the environment in many different ways. More and more countries together with the respective regulatory organizations are starting to introduce various initiatives and projects regarding electronic leaflets implementation. Where? How? The answers to these questions are below. But let`s start from the beginning >>
Table of Contents
ePI Initiative
ePI is an acronym for EU Common Standard for electronic product information. ePI is authorized statutory product information for medicines 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.
EMA and a group of EU national competent authorities are testing the use of ePI in a one-year pilot project from July 2023. The pilot covers both centralized and national regulatory procedures. Participating countries include Denmark, the Netherlands, Spain and Sweden. This pilot is supported by the EU funding program EU4Health.
During the pilot, companies create and manage ePIs during regulatory procedures, using an ePI authoring tool on the Product Lifecycle Management Portal. Here you could search and browse an ePI of authorized PI published in the context of the ePI pilot project – https://plm-portal.ema.europa.eu/ePIAll/
The EU ePI Common Standard refers to the technical features of ePI agreed upon by regulators and stakeholders.
e-PIL Pilot Project in Luxembourg and Belgium
ePIL Pilot Project started in 2018 in cooperation between the associations of the (bio)pharmaceutical industry in Belgium (pharma.be) and Luxembourg (IML). The e-PIL Pilot aims to switch the traditional paper PILs to e-PILs in selected hospital-only medicinal products that are available on the Belgium and/or Luxembourg market.
To track the perception of the project, a survey was conducted at the beginning of the Pilot in 2018, and it was repeated after 12 and 24 months. The first outcome shows good as:
- 96% consulted the e-PIL version and 4% printed the leaflet from an online source
- 98% of responding pharmacists declared that the absence of the PIL had not caused any inconvenience
- 98% of the respondent hospital pharmacists would agree to the removal of the paper PIL from all hospital-only medicines
Due to the great results, in August 2022, the EU Commission allowed a new extension of this pilot project for three years and its scope to new medicines exclusively used in hospitals: Phase 1 โ 01 August 2018 โ 01 August 2022; Phase 2 โ 01 August 2020 โ 01 August 2022; Phase 3 โ 01 August 2022 โ 01 August 2025.
APAC E-Labeling
Many countries in the Asian markets are working towards e-labeling implementation. During the 13th Asia Partnership Conference of Pharmaceutical Associations (APAC) were presented the current statuses of e-labeling implementations in the following countries:
E-Labeling Pilot Project in Indonesia
The formation of the e-labeling task force in Indonesia started in 2022. The implementation of the Pilot Project E-Labeling is carried out for 2 years starting from December 2023 to November 2025.
The project`s phases are as follows:
- Phase I (1st to 3rd month) for Vaccine and Injection
- Phase II (4th to 6th month) for Rx drugs including Vaccine & Injection
- Phase III (7th to 24th month) for OTC and Rx drugs including Vaccine & Injection
The first stage has been implemented for 24 vaccines and injection products, starting in December 2023 โ February 2024. The survey after the completion of the first stage showed that:
- 94% of e-labeling products have been accessed through the BPOM Mobile application;
- 7 out of 24 e-labeling products have been reported to have reduced their paper usage.
E-Labeling in South Korea
In the e-labeling pilot project that started in 2023 took participation 10 companies (MAHs), and 27 products (18 locally manufactured and 9 imported). Of these 27 products – 6 products were provided with both e-labeling and paper inserts; and 21 products with e-labeling only. The project duration was expanded to 2024, increasing the number of products to 109 (from 27 MAHs).
South Korea is carrying out e-labeling projects also in the Cosmetics and Food industries.
E-Labeling in Malaysia
The pilot project for e-labeling was conducted in three phases from May 2023 to January 2024. PhAMA will continue to collaborate with the Ministry of Health and the pharmaceutical industry on implementing e-labeling in Malaysia, focusing on the Voluntary Phase until 31 December 2026 and for the plans beyond.
E-Labeling in Taiwan
In September 2023, the Taiwan FDA updated and announced their plans on E-leaflets with a broader scope:
- Medicinal products of Injection forms: biological product#, antitumor products$, antibiotics, contrast medium, essential drug product announced & products with RMP project
- Prescription products in oral forms: vaccines & contrast medium
- Above mentioned excludes Special Imported products & products to be brought home and used by patients
The paper leaflet can be removed from the pack but should always be available on demand, at least one (latest) paper leaflet needs to be provided to the medical organizations & pharmacies
E-Labeling Implementation in Japan
In December 2019, the Pharmaceuticals and Medical Devices Act was amended to introduce e-labeling officially, replacing paper labeling and accompanying necessary scheme that enables all healthcare professionals to access the up-to-date labeling information. The GS1 bar code is required to print on the outer box so that healthcare professionals can access labeling information. A mobile app for reading GS1 barcode became available in May 2021. The enforcement of the amendment was implemented on Aug 1, 2021. There is a 2-year transition period and paper labeling has been removed by the end of July 2023.
The Role of GS1 Standards
To support decision-making by the relevant health authorities and define harmonised implementation by the healthcare industry, GS1 HC developed recommendations on how to access digital content for medical products >> https://www.gs1.org/sites/gs1/files/2023-12/gs1seg231205-01-for_hclt_gs1_stds_to_access_digital-content_in_hc_a4_08.pdf
Conclusion
In conclusion, The great potential in E-Labeling is discovered by the pharma industry and the positive results from the implementation are fact.
Briefly, the key drivers for e-labeling implementation are:
- availability of the latest labeling on a publicly accessible website (e.g., product information available online);
- accessible through a reader-friendly format (e.g., scanning a machine-readable code);
- eliminating paper labeling from commercial packages;
- common electronic standard (e.g., structured content);
- efficient information flow (e.g., interoperability between systems).
Sources:
https://pharma.be/sites/default/files/2022-06/rr-april-2022-e-pil.pdf
