EMA Guidance: Anonymisation and Confidentiality in Risk Management Plans (RMPs)

The European Medicines Agency (EMA) has published a revised guideline titled "Guidance on the Anonymisation of Protected Personal Data and Assessment of Commercially Confidential Information (CCI) during the Preparation of Risk Management Plans (RMPs)", dated 11 April 2025. This document provides clear and structured guidance to Marketing Authorisation Holders (MAHs) and applicants on how to handle personal data (PD) and commercially sensitive information during the drafting, submission, and post-approval publication of RMPs.

The guidance primarily targets RMP body text and Annexes 4 and 6, ensuring both regulatory transparency and data privacy compliance under GDPR and EU pharmaceutical legislation.

• Risk Management Plan (RMP): A comprehensive document that outlines the safety profile of a medicine and describes the measures taken to minimize its risks.

• Protected Personal Data (PPD): Information that relates to an identified or identifiable natural person. This includes, but is not limited to, names, contact details, dates of birth, and medical information.

• Commercially Confidential Information (CCI): Information that, if disclosed, could harm a company's competitive position. This might include manufacturing details, development plans, or specific contractual agreements.

RMP Content Guidance: What to Anonymize or Delete Before Submission

This guidance applies to drafting the RMP before its submission for evaluation. The goal is to prepare an RMP that can be published without further redaction.

1. Personal Data (PD)

Identifiers related to study personnel/company employees

Identifiers	Anonymization Rules
Name of Qualified Person for Pharmacovigilance (QPPV)	Always Retain
QPPV contact details (i.e., email address, phone/fax number)	Delete
Names of company employees and their contact details	Delete
Handwritten signatures, names, dates, or other handwritten text	Delete

Identifiers related to individual study participants or individual entries

Identifiers	Anonymization Rules
Study participant/subject ID or screening randomization number	Delete and transform (e.g., replace by 'one/a study participant')
Serious adverse event number/code	Delete and transform if applicable (e.g., replace by 'one case')
Date of birth	Delete OR Transform as generalized age (age band1)
Place of birth/nationality	Delete
Date of death	Generalize to relative study day (e.g., replace by 'Day 30' or '30 days after the first dose') OR Delete if generalization is not possible
Reporting country for adverse event/adverse drug reaction	Delete OR Transform (e.g., generalize to region)
Sensitive and/or newsworthy information at individual subject level	Delete OR Transform (e.g., generalization)
Sex/gender and related pronouns	Retain OR Delete/transform if high risk of re-identification (e.g., patient in a small group for sex/gender)
Age	Retain (if low risk of re-identification) OR Transform (e.g., generalization $$age band1]) OR Delete (if high risk of re-identification)
Health data calendar dates	Transform (e.g., generalization to relative study day, month/year, or year) OR Delete if high risk of re-identification
Study relative days	Retain
Racial group/heritage	Delete OR Retain (if low risk of re-identification and/or relevant for data utility and interpretation)
Ethnicity	Delete OR Retain (if low risk of re-identification and/or relevant for data utility and interpretation)

2. Editorial/administrative notes

• 'Confidential' labels/watermarks and confidentiality statements must be deleted.

• All document properties (e.g., author’s name) and metadata should be removed using the "sanitize document" function.

3. Commercially Confidential Information (CCI)

The MAH should propose CCI deletions where applicable, only for those elements considered CCI. The MAH should not propose the redaction of entire paragraphs or sub-sections of a document.

• Exposure data (patient exposure and sales volume) presented by country.

• Detailed information on ongoing clinical studies.

• Information on future development plans or regulatory strategy.

• Detailed information on studies which are part of an ongoing paediatric development plan (PIP).

• Specifics on the manufacture and quality control of active substance(s) and final product.

• Names/contractual agreements of/with service providers/material suppliers.

The following information will not be accepted by EMA as CCI:

• Cumulative exposure data from clinical trials.

• Cumulative post-marketing exposure data.

• The standard method to calculate exposure based on the posology of the product and/or treatment cycles.

RMP Redaction Guidance: What to Redact After Approval

This content guidance applies to the anonymization/redaction of the approved RMP, post-opinion. This includes the body and annexes 4 and 6.

1. Personal Data (PD)

Identifiers related to study personnel/company employees

Identifiers	Redaction Rules
QPPV’s name	Always Retain
QPPV’s contact details (i.e., email address, phone number)	Redact
Names of company employees and their direct contact details	Redact
Handwritten signatures, names, dates, or other handwritten text	Redact

Identifiers related to individual study participants in narratives or individual participant entries

Identifiers	Redaction Rules
Study participant/subject ID or screening randomization number	Anonymise/Redact
Serious adverse event case number/code	Anonymise/Redact
Date of birth	Redact DD/MM only OR Redact (if high risk of re-identification)
Place of birth/nationality	Redact
Date of death	Redact DD/MM only
Reporting country for adverse event/adverse drug reaction	Redact
Sensitive and/or newsworthy information at participant’s level	Redact
Sex/gender and personal/possessive pronouns	Retain OR Redact (if high risk of re-identification)
Age	Retain OR Redact (if high risk of re-identification)
Health data/study calendar dates	Retain OR Redact DD/MM only (if high risk of re-identification)
Study relative days	Retain
Racial group/heritage	Retain OR Redact (if high risk of re-identification)
Ethnicity	Retain OR Redact (if high risk of re-identification)

2. Editorial/administrative notes

• 'Confidential' or confidentiality statements from headers/footers of document must be redacted.

• All document properties (e.g., author’s name) and metadata should be removed.

3. Commercially Confidential Information (CCI)

The general principles for CCI redaction remain consistent with the pre-submission guidance.

The Process: Submission, Redaction, and Publication

The EMA outlines a specific process for submitting and redacting RMPs:

1. Drafting the RMP: MAHs should proactively anonymize PPD and remove CCI from the draft RMP before submitting it to the EMA for evaluation.

2. Post-Opinion Redaction: After the Committee for Medicinal Products for Human Use (CHMP) issues its opinion, the MAH is requested to send three files to EMA via EudraLink:

   • The (redacted) RMP file.

   • An RMP file showing the redaction proposals (see-through boxes).

   • The signed declaration for the RMP publication, see the template.

3. EMA Review: The EMA reviews the proposed redactions to ensure they comply with the guidance.

4. Publication: The redacted RMP is then published on the EMA's product page.

For the most up-to-date information and the full guidance document, please refer to the EMA website: Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)