Module 6

04/10/2024

Public Assessment Reports are a set of documents describing the evaluation of a medicine authorised by a regulatory agency European Public Assessment Reports - EPARs

• Prepared by many regulatory agencies since 2000

• Variable levels of detail in national agency documents

EMA has the most extensive PAR known as the EPAR

• Published for every human or veterinary medicine application that has been granted or refused a marketing authorisation

• Provides public information on a medicine, including how it was assessed by EMA

• Includes the Product Information

• MAH has opportunity to review prior to its publication on EMA’s website

• Allowed to delete personal data and company confidential information, essentially CMC only – full publication expected for nonclinical and clinical

• Updated periodically to reflect the latest regulatory information on medicines

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EPAR – a collection of documents

Section

Type of Information

Example:

• Public-friendly overview in Q&A format including RMP summary

Overview

https://www.ema.europa.eu/en/medicines/human/ EPAR/orserdu

• Key details about the product and the MAH

Authorisation details

EPARs are a useful tool for regulatory professionals:

• SmPC, Conditions of MA, Labelling, Package leaflet • List of all authorised presentations (Annex A) • Pharmacotherapeutic group • Therapeutic indications

• Getting to know a new product

Product information

• Reviewing competitor products

Designing clinical trials

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Also used by commercial, HTA bodies (for pricing and reimbursement), patients, HCPs, regulatory agencies in other regions

• Public assessment report – initial MAA • Public assessment report – major variations • Orphan maintenance assessment report or withdrawal • Tabulated overview of submissions

Assessment history

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