'Femi Fajimi

Writing Safety Updates in Regulatory Medical Writing: An Overview of RMPs, DSURs, PADERs, and PBRERs from a Developing Writer’s Perspective 

By ‘Femi Fajimi | 13 July 2025 

One of the most critical responsibilities in regulatory writing is preparing safety documents that monitor, assess, and communicate drug safety throughout its lifecycle. These documents help regulatory authorities and stakeholders assess a product’s ongoing benefit-risk profile and identify emerging concerns. 

As a developing medical writer, I’ve come to appreciate how these documents connect data, regulatory requirements, and public health goals. Understanding their structure and purpose has been crucial to developing my skill set. 

1. Risk Management Plan (RMP) 

An RMP is a regulatory document required in the EU that outlines how risks associated with a medicinal product will be monitored and minimised after authorisation. 

Key components: 

• Safety concerns (identified, potential, and missing information) 

• Pharmacovigilance activities (routine and additional) 

• Risk minimisation measures 

• Evaluation of the effectiveness of these measures 

When required: At the time of Marketing Authorisation Application (MAA) and throughout the product lifecycle. 

2. Development Safety Update Report (DSUR) 

The DSUR is an annual report for investigational drugs under development. It provides regulators with a consolidated picture of the drug’s safety profile across all trials. 

Key sections include: 

• Cumulative safety data from ongoing studies 

• Important risk summaries 

• Non-clinical findings 

• Overall safety assessment 

When required: Annually during clinical development. 

3. Periodic Adverse Drug Experience Report (PADER) 

The US FDA requires a PADER for post-marketing safety reporting. It consolidates adverse event data, literature findings, and any product safety updates. 

Typical content: 

• Individual Case Safety Reports (ICSRs) 

• Label updates and safety signal evaluations 

• Communication with healthcare professionals 

When required: Quarterly for the first 3 years post-approval, then annually. 

4. Periodic Benefit–Risk Evaluation Report (PBRER) 

The PBRER provides a global view of a product’s evolving benefit-risk profile. It builds upon earlier PSURs and includes both safety and efficacy data. 

Includes: 

• Benefit-risk evaluation 

• Global regulatory updates 

• Cumulative adverse events and patient exposure 

• Literature summaries 

When required: Periodically for marketed products as specified by regulators. 

What Medical Writers Should Know 

Document	Phase	Focus	Audience	Region
RMP	Post-approval	Risk minimisation strategy	EMA	EU
DSUR	Clinical trials	Development-stage safety	EMA/FDA/ICH	Global
PADER	Post-approval	US-specific safety updates	FDA	US
PBRER	Post-approval	Global benefit–risk profile	EMA/FDA/ICH	Global

Writing Tips for Safety Documents 

• Use regulatory terminology accurately (e.g. MedDRA terms). 

• Maintain consistency across summaries, appendices, and case data. 

• Avoid overinterpretation: present facts clearly with context. 

• Understand timelines and submission cycles. 

• Collaborate with pharmacovigilance and safety teams to clarify content. 

Final Thoughts 

For developing regulatory writers, contributing to safety documents is both a challenge and a privilege. These documents reinforce our role in supporting product safety, regulatory decision-making, and patient well-being. 

Learning how to structure and interpret documents like RMPs, DSURs, PADERs, and PBRERs adds depth to our writing experience and prepares us for more complex regulatory submissions. 

Author’s Note 

This article is written from the perspective of a developing regulatory medical writer aiming to understand and communicate the role of safety documents in clinical development. While every effort has been made to ensure accuracy and clarity, I welcome professional insights, corrections, or suggestions to improve my understanding. 

Thank you for reading. 

— Femi Fajimi 

References: 

• EMA. Good Pharmacovigilance Practices (GVP): www.ema.europa.eu 

• ICH Guidelines E2F & E2C(R2): www.ich.org 

• U.S. FDA 21 CFR 314.80: www.ecfr.gov