Hi All,
In this article we will see What are Aggregate Reports in Pharmacovigilance?
Aggregate report is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide. The aggregate report examines and summarizes all existing safety experience with a medicinal product.
Cumulative or Aggregate reporting, also known as Periodic Reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports.
The periodic reports play an important role in risk-benefit evaluation of the drug and involves collective analysis of cases in the database, monitoring regulatory actions, literature searches etc. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.
Types of Aggregate Reports
A) Pre-Marketing Reports
2. Clinical Study Reports (CSR)
3. Development Safety Update Report (DSUR)
4. Annual Safety Reports (ASR)
B) Post-Marketing Reports
2. PADER (Periodic Adverse Drug Experience Report)
3. ACO (Addendum to Clinical Overview)
4. NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) Reports
The following terms are commonly used in aggregate reporting.
DIBD
Developmental International Birth Date (DIBD) is the date of approval of the first authorization for conducting an interventional clinical trial in any country.
The first data lock point for the DSUR is the first anniversary of the DIBD.
IBD
International Birth Date (IBD) is the date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.
If a marketing authorisation holder has no information on the actual IBD for a product, it should first refer to listings of birth dates that some regions develop and make publicly available. If the product is not included in any listing, it should propose to the regulatory authority a birth date that is based on the earliest known marketing authorisation of the substance and then obtain the regulatory authority’s agreement.
DLP
The Data Lock Point (DLP) represents the cut-off date for data and analyses presented in a document.
- For a periodic safety update report (PSUR), the date designated as the cut-off date for data to be included in a PSUR.
- For a periodic benefit-risk evaluation report (PBRER), the date designated as the cut-off date for data to be included in a PBRER, based on the international birth date (see GVP Annex IV, ICH-E2C(R2) Guideline).
- For a development safety update report (DSUR), the date designated as the cut-off date for data to be included in a DSUR, based on the development international birth date (see ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).
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Regards,
PV and Drug Safety