How Often is PBRer Submitted? A Guide to Pharmacovigilance Reporting

October 8, 2025 •

3 min read

The PBRER submission schedule is not a single, fixed timeline but varies based on factors like a drug's lifecycle, with new products requiring more frequent reports initially before transitioning to less frequent intervals. This variable reporting frequency is a cornerstone of modern pharmacovigilance and directly addresses the question of How often is PBRer submitted?.

Quick Summary

The frequency of PBRER submissions is highly dynamic and depends on regulatory guidelines, the product's marketing duration, and regional mandates. Schedules typically begin with frequent reporting and decrease over time, though specific events can prompt ad-hoc submissions.

Key Points

Dynamic Frequency: PBRer submission frequency changes over a product's lifecycle, starting with more frequent reporting for new drugs and decreasing for established ones.
Initial Schedule: For the first two years after market authorization, PBRERs are typically submitted every six months to regulators.
Long-Term Reporting: After the initial years, the schedule usually shifts to an annual cycle and may become even less frequent (e.g., every 3 years) for mature products.
Regulatory Authority Influence: Different regions (e.g., EU, US, Canada) and individual regulatory bodies can mandate specific frequencies or request ad-hoc PBRERs based on their rules or safety concerns.
Data Lock Point (DLP): Submissions are tied to the DLP, with deadlines typically 70 days for intervals up to 12 months and 90 days for longer periods.
International Birth Date (IBD): The PBRER cycle for a product is aligned with its IBD, the date of the first global marketing authorization, to promote harmonization.

Understanding the Periodic Benefit-Risk Evaluation Report (PBRER)

The Periodic Benefit-Risk Evaluation Report (PBRER) is a crucial pharmacovigilance document used in regulatory compliance for marketed products in International Council for Harmonisation (ICH) regions. It is an evolution of the traditional Periodic Safety Update Report (PSUR), focusing on a comprehensive assessment of a drug's overall benefit-risk profile rather than just individual adverse events. Marketing Authorization Holders (MAHs) are required to submit these reports to regulatory authorities to ensure medicines remain safe and effective. The frequency of these submissions is a key part of post-market surveillance.

The Lifecycle Approach to PBRER Submission

The frequency of PBRER submission changes throughout a medicinal product's lifecycle. This ensures closer monitoring of newer products and adjusts as their safety profile becomes more established.

The Initial Phase: High-Frequency Reporting

Newly marketed products typically require more frequent reporting. In many ICH regions, the schedule is:

First Two Years: Submissions are required every six months from the International Birth Date (IBD), the date of the first marketing authorization globally.
Submission Deadline: PBRERs for these six-month periods must be submitted within 70 days of the Data Lock Point (DLP), the data cut-off date.

The Intermediate Phase: Annual Reporting

After the initial two years, reporting often moves to an annual cycle:

Years 3 and 4: Annual submissions are generally required. The submission deadline for intervals longer than 12 months is 90 days after the DLP.

The Mature Phase: Less Frequent Reporting

For products with an established safety profile, reporting frequency may decrease further:

After Year 4: Reporting might become triennial in regions like the EU. The EMA's EURD list provides specific schedules for EU-authorized products, which can vary.

Influences on Reporting Frequency

Factors other than the standard lifecycle can affect submission frequency:

Regional Regulations: Submission frequency can vary between regulatory bodies globally. Local rules and implementation of guidelines like ICH E2C(R2) may differ.
Ad-Hoc Requests: Regulatory authorities can request a PBRER submission at any time if safety concerns arise.
Significant Changes: Changes in a product's use or safety profile can lead to altered reporting frequency.
Product Type: Requirements may differ for certain products like generics unless specific safety issues are found.

Comparing PBRER Submission Schedules

The table below shows typical PBRER submission frequencies and contrasts them with the historical US PADER format, which had different requirements before the FDA adopted the PBRER format.


Feature	PBRER (Typical ICH/EU Schedule)	PADER (Historical US Schedule)
Initial Phase (0-2 years)	Every 6 months	Quarterly for the first 3 years
Intermediate Phase (2-4 years)	Annually	Annually after 3 years
Mature Phase (After 4 years)	Every 3 years or longer (as per EURD list)	Annually
Submission Window	70 or 90 days after DLP	30 or 60 days after DLP
Content Focus	Comprehensive benefit-risk evaluation	Detailed individual case reports
Regulatory Basis	ICH E2C(R2), EMA Module VII	US 21 CFR 314.80

The Role of the International Birth Date (IBD)

The International Birth Date (IBD) is crucial for PBRER scheduling. It is the date of the first marketing authorization globally for an active substance. This date serves as the reference for the DLP and helps harmonize reporting schedules across different regions, though local regulations can introduce variations.

Conclusion: A Dynamic and Crucial Process

To answer how often is PBRer submitted, it's clear the process is dynamic and dependent on a product's lifecycle, regulatory requirements, and emerging safety data. From frequent initial reports to less frequent submissions for established medicines, the PBRER schedule ensures continuous monitoring of a drug's benefit-risk profile. Adhering to these varied schedules is essential for pharmaceutical companies to provide regulators with the data needed to make informed decisions about product safety throughout its market life.

Frequently Asked Questions

A PBRer (Periodic Benefit-Risk Evaluation Report) is a comprehensive pharmacovigilance document submitted by marketing authorization holders to regulatory authorities. It provides an updated evaluation of a drug's overall benefit-risk profile, considering new safety and efficacy data.

The frequency is dynamic because it is based on a product's lifecycle. Newer products require closer monitoring due to less cumulative data, so they are reported on more frequently. As a product matures and its safety profile becomes more established, the reporting frequency can decrease.

Regulatory authorities in different regions have their own guidelines. While many follow the ICH E2C(R2) standard, specific requirements can vary. Authorities can also request ad-hoc reports outside the standard schedule if safety concerns arise.

The IBD is the date of the first marketing authorization for an active substance granted anywhere in the world. It serves as the global reference date for setting the PBRer reporting cycle and the data lock point.

The DLP is the cut-off date for data included in a specific PBRer reporting period. All safety data up to the DLP is included in that report, and the submission deadline is calculated from this date.

If there are important changes, such as a new indication, a regulatory authority may alter the PBRer reporting frequency. This is done to ensure the benefit-risk profile is re-evaluated in light of the new information.

The PBRer is a global standard for evaluating the overall benefit-risk profile of a product, while PADER was a US-specific report focusing on individual adverse drug experiences. The PBRer has a broader scope, and the FDA now accepts the PBRer format in many cases.