Writing a Periodic Safety Update Report (PSUR) in pharmacovigilance involves a structured and

detailed approach. Below are step-by-step instructions with fictitious data to help you write a PSUR:

Step 1: Introduction

Start by introducing the PSUR, including the product name, active substance(s), and the reporting
period covered by the report. Include the contact information of the marketing authorization holder
(MAH) and the date of the report.

Example:

Product Name: XYZ Pharma Drug

Active Substance: Fictinium

Reporting Period: January 1, 2022 - December 31, 2022

Step 2: Executive Summary

Provide a concise summary of the key findings and conclusions of the report. Highlight any
significant safety concerns, new safety information, or changes in the benefit-risk profile of the
product.

Example:

During the reporting period, no new safety concerns were identified for XYZ Pharma Drug. The
benefit-risk profile remains favorable, and the available safety data supports the continued use of
the product.

Step 3: Regulatory Updates

Include any relevant regulatory updates, such as changes in the product's labeling, product recalls,
or regulatory actions taken by competent authorities.

Example:

No regulatory updates or actions were reported during the reporting period.

Step 4: Periodic Safety Update

Provide an overview of the data sources and methodologies used to collect and analyze safety data.
Describe the adverse events (AEs) reporting system, including the number of AEs received, the type
of reports (spontaneous, clinical trials, literature), and any efforts made to ensure data quality.

Example:

The safety data for this PSUR was obtained from spontaneous reports, clinical trials, and literature
review. A total of 500 AEs were reported during the reporting period, with 400 coming from
spontaneous reports, 80 from clinical trials, and 20 from literature sources. Data quality was ensured
through regular monitoring and validation processes.

Step 5: Safety Data Analysis

Analyze the safety data collected during the reporting period. Present the number and types of AEs,
including serious and non-serious events. Identify any trends, patterns, or new safety signals.
Compare the data with previous reporting periods to assess any changes.

Example:

The most frequently reported AEs were headache (25%), nausea (20%), and fatigue (15%). No new
safety signals or trends were identified. The occurrence of serious AEs remained consistent with
previous reporting periods.

Step 6: Benefit-Risk Assessment

Evaluate the benefit-risk profile of the product based on the safety data and other available
information. Discuss the known risks and benefits, taking into account any new safety information or
changes in the regulatory environment.

Example:

The benefit-risk assessment remains positive for XYZ Pharma Drug. The known risks, such as
headache and nausea, are manageable and outweighed by the therapeutic benefits of the product.
No new safety concerns were identified.

Step 7: Risk Minimization and Pharmacovigilance Activities

Describe any risk minimization activities implemented during the reporting period, such as changes
in the product labeling, educational programs, or targeted safety communications. Discuss the
effectiveness of these activities in mitigating risks and improving patient safety.

Example:

No specific risk minimization activities were implemented during the reporting period. However,
routine pharmacovigilance activities, including signal detection, periodic safety reviews, and safety
communication updates, were conducted to ensure ongoing monitoring and management of
product safety.

Step 8: Conclusion

Summarize the key findings and conclusions of the PSUR, emphasizing the overall safety profile and
benefit-risk balance of the product. Highlight any recommendations for further safety monitoring or
actions, if applicable.

Example:

In conclusion, the PSUR for XYZ Pharma Drug during the reporting period shows no new safety
concerns or significant changes in the benefit-risk profile. The available safety data supports the
continued use of the product. No additional safety monitoring or actions are recommended at this
time.

Step 9: Annexes

Include any relevant annexes, such as tables, graphs, or additional data supporting the findings and
conclusions of the PSUR.

Example:

Annex 1: Summary of Adverse Events

Annex 2: Comparative Analysis of Reporting Periods

Annex 3: Regulatory Updates

Remember to adapt the instructions and examples to your specific PSUR requirements and
guidelines.
Writing a Periodic Safety Update Report (PSUR) in pharmacovigilance involves a systematic and
comprehensive assessment of the safety profile of a medicinal product. Here is a step-by-step
instruction with fictitious data and detailed information to help you write a PSUR:

1. Introduction:

- Start by introducing the medicinal product for which the PSUR is being prepared.

- Provide details like the brand name, active ingredients, indications, and the date range covered
by the report.

Example:

The PSUR is prepared for the fictitious medicinal product "MediSafe," containing the active
ingredient "Fictidine." MediSafe is indicated for the treatment of hypertension and has been on the
market since January 2019. This report covers the period from January 1, 2020, to December 31,
2020.

2. Safety Data Collection:

- Collect safety data from various sources, including clinical trials, post-marketing surveillance,
literature, and spontaneous reports.

- Use fictitious data to demonstrate the process.

Example:

Safety data were collected from multiple sources, including 5 clinical trials involving a total of 2,000
patients, post-marketing surveillance from 10 countries, literature review of 50 articles, and 500
spontaneous reports received during the reporting period.

3. Adverse Event Analysis:

- Analyze and evaluate the adverse events (AEs) reported for the medicinal product.

- Organize the AEs by system organ class (SOC) using the Medical Dictionary for Regulatory
Activities (MedDRA) terminology.

- Include the number of AEs, seriousness, outcome, and any relevant risk factors.
 Example:

The most frequently reported AEs were related to the nervous system (n=150), followed by
gastrointestinal disorders (n=100) and cardiovascular disorders (n=80). Among the reported AEs, 10
cases were considered serious, with 2 resulting in death. Risk factors identified for these serious
cases included concomitant use of other medications and pre-existing cardiovascular conditions.

4. Signal Detection:

- Perform signal detection to identify any potential safety concerns or emerging risks associated
with the medicinal product.

- Use statistical methods, data mining, and other pharmacovigilance tools to assess the data.

Example:

Signal detection analysis did not identify any new or unexpected safety concerns during the
reporting period. The known safety profile of MediSafe, including previously identified AEs,
remained consistent with the product information.

5. Benefit-Risk Assessment:

- Evaluate the overall benefit-risk balance of the medicinal product based on the available safety
and efficacy data.

- Consider the severity of the disease, available alternative treatments, and the therapeutic
benefits.

- Use fictitious data to support your assessment.

Example:

The benefit-risk assessment continues to favor the use of MediSafe for the treatment of
hypertension. Despite the reported AEs, the therapeutic benefits in terms of blood pressure control
and reduction of cardiovascular events outweigh the potential risks identified during the reporting
period.

6. Conclusion and Recommendations:

- Summarize the findings of the PSUR and draw conclusions based on the safety data.
 - Provide recommendations for any necessary actions, such as updates to the product information
or risk minimization measures.

Example:

Based on the safety data collected and analyzed, no new safety concerns were identified for
MediSafe during the reporting period. The benefit-risk remains favorable, and no specific
recommendations for changes to the product information or risk minimization measures are
currently warranted.

Remember to adapt the instructions and examples to fit your specific requirements and regulatory
guidelines.