Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format. In such scenarios, applicants are burdened with making last-minute amendments, which cause a delay in submission or, in an extreme case, a technical rejection of the entire submission.
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
We have come a long way in the journey of Product Information (PI) and Quality Review Documents (QRD) since then.
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages. A dedicated Working Party (WP) is assigned by the European Medicines Agency (EMA) for Quality Review of Documents (QRD). The WP develops, reviews, and updates templates as per the authority requirements for Marketing Authorization Holder’s (MAH’s) perusal.
Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.