Aggregate Reporting In Pharmacovigilance

                                         

Compier (PV) Aggregate Reports | Pharmacovigilance Reporting | Techsol


 What are Aggregate Reports?

Aggregate reports are the reports which emphasize on evaluation of safety profile and benefit-risk and do not focus much on individual cases. An aggregate report is a process that reviews the cumulative safety information from a wide range of sources, periodically and submits the findings to regulators worldwide. 


Why is aggregate reporting important?

The aggregate report plays an important role in the safety assessment of drugs; it is also known as periodic reporting and cumulative safety information. The main purpose of an aggregate study is to make a report on safety information for a drug over an extended period.


Classification of Aggregate Reporting

Aggregate reports are necessary during both the pre-marketing and post-marketing stages of a product. The reports of each stage identify and highlight a specific aspect of risk or benefit. 

Pre-marketing Report:

These reports include the cumulative summary of safety information for molecules under clinical development. These reports usually include safety information from non-clinical studies and safety data of the subjects who participated in the clinical trial.

Post-marketing Report:

 The post-marketing reports provide the cumulative summary of the company’s core safety information for the medicinal products that are already marketed.

Aggregate Reports for respective stages.


Development Safety Update Report (DSUR)

  • DSURs are new, internationally harmonized, safety documents (which became mandatory in European Union member states in September 2011) covering the safety summary of drug products during their development or clinical trial phase.

  • The new DSUR (defined in guideline ICH E2F) depends heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase. This new DSUR format replaces the previous European Union ASR (Annual Safety Report) and the United States IND Annual Report.

  • DSURs have been submitted by the sponsors within one year of the Development International Birth Date (DIBD – the date of first authorization of a clinical trial in any country worldwide) and provide annual DSUR submissions until all open clinical studies have ended (the final clinical study is completed, and its study report has been submitted).

Periodic Safety Update Report (PSUR)

  • PSURs are important pharmacovigilance documents applying to drugs already approved for marketing – regularly updating regulatory authorities on the worldwide safety experience of approved medicinal products.

  • A new format for PSURs is the PBRER (Periodic Benefit Risk Evaluation Report: ICH E2C (R2)), which came into force in the European Union and European Economic Area on 2nd July 2012 – as the result of the European Medicines Agency (EMA) guidance on Good Pharmacovigilance Practices (GVP) issued in June 2012. The same PBRER format has also been provided to replace PADERs in the United States.

  • PSURs must be submitted every 6 months after product authorization until 2 years after the initial placing on the EU market, yearly for the following 2 years, and at 3-year intervals thereafter.

Periodic Adverse Drug Experience Report (PADER)

  • PADERs are postmarked periodic drug safety reports required in the USA by FDA regulations §§314.80(c)(2) and 600.80(c)(2)

  • PADERs have largely been superseded by the new Public Benefit-Risk Evaluation Report (PBRER) defined in ICH E2C(R2), following FDA endorsement in November 2012 of the format designed for harmonized use across all ICH regions. The PBRER also forms based on the current version of the European Periodic Safety Update Report (PSUR).

  • PADERs/PBRERs are required to be submitted by the sponsors quarterly for the first 3 years after drug approval in the USA, and annually thereafter.

Conclusion

The Aggregating Report can be only achieved by working and collaborating continuously with drug manufacturers to promote international harmonization of PV regulations and with the regulators worldwide.  Aggregate safety reports should submit to regulators for a period of the medicine that is marketed anywhere in the world and enables the understanding of the risk-benefit of the product over some time. The new product is introduced in different markets. Reporting and using data on clinical protection information should be considered as part of persistence. The regulatory requirement for submission frequency and aggregate report content is not the same for all countries. To avoid duplicating effort, the important data should be submitted with constancy to regulatory authorities.


References



Student Name: Swathi Jaggannolla

Student ID: CSRPL_STD_IND_HYD_ONL/CLS_003/012023

Qualification: M. Sc 

e-Mail ID: swathi.vijayareddy@gmail.com

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