AGGREGATE REPORTING

                                            

INTRODUCTION:

Aggregate reportage is that the method of compilation and submission of mixture reports to the restrictive agencies over the amount of the product’s life cycle (during pre-marketing and post-marketing phase) to supply a comprehensive read of the drug’s safety profile.

These reports focus not such a lot on individual cases, however rather on summary, assessment of the protection profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and therefore the Serious Adverse Event (SAE) and gestation reports.  

      

Why Aggregate Reporting?

Aggregate reports are meant to supply associate degree analysis of the benefit-risk analysis balance for submission by pharmaceutical firms to the regulatory authorities at an outlined purpose of time throughout the post-authorization section. But why is aggregate reporting essential?

1. As larger numbers of people are exposed to the medication compared to clinical trials, it's essential that real-world drug safety data is gathered within the post-marketing section. Throughout this stage, rare AE (Adverse Events) that haven’t been known earlier may return to light.

2. Medicinal product administered in real-world patients with underlying diseases tends to possess varied reactions. Once submitted through aggregate reports, such info can prove crucial for more studies on deciding the restrictions of the merchandise.

AIM:

• Present all relevant information from various sources.

• Relate these data to patient exposure to the drug.

• Evaluate the drug’s approval status in various countries.

• Assess if any action required to optimize the benefit-risk profile of the drug.

CLASSIFICATION

          

1. PRE-MARKETING REPORTS

 IND Annual report:

• A narrative or tabular summary showing the clinical and non clinical investigations conducted under the IND application.

• This report should be submitted annually until the final clinical study report that IMP has been submitted to FDA.

Clinical Study Reports (CSR):

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description and analyses are fully integrated into a single report.

Objective:

To allow compilation of a single core Clinical Study Report acceptable to all regulatory authorities of the ICH regions.

Development Safety Update Report (DSUR):

• Covers safety information of IMP.

• A single DSUR includes safety data from all the clinical trials conducted on IMP. The safety issues revealed throughout the reporting period should be disclosed in the DSUR.

• It additionally notes actions taken to reflect new or current risks.

• Pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR)

• Submitted annually.

Objective:

The potential risks are summarized based on the current understanding and management.

2. POST MARKETING REPORTS

Periodic Safety Update Report (PSUR)

• PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time point after its authorization.

• A PSUR assessment will verify if additional investigations on a particular issue are required, or if associate action is critical to safeguard public health (e.g. an update of knowledge provided to health care professionals and patients).

         

Periodic Benefit-Risk Evaluation Report (PBRER)

The scope of the PBRER has been extended to incorporate profit also as safety, the reference data for the report conjointly has to take this new issue under consideration. It is generally impractical for Market Authorization Holders (MAHs) to have one reference information source that:

• Encompasses all parameters that contribute towards the benefit-risk evaluation, (i.e., benefit, effectiveness, indications and safety information);

• Is common to all ICH regions; and

• Addresses all circumstances, (e.g., generics, product authorized in one country only).

Objective:

• To present products overall benefit-risk profile.

Periodic Adverse Drug Experience Report (PADER)

• PADER is a document where all new data from adequate sources should be reported, where the data is related to patient body response to the medicine.

Objective:

• To provide summary data on safety profile of the drug and to update and evaluate a medicine’s global data and provide information about drug safety. 

REFERENCES:

1. Aggregate Reporting – Significance, Classification and Challenges (techsollifesciences.com)

2. 23. Aggregate reporting – Introduction | Pharmacovigilance (allaboutpharmacovigilance.org)

3. Fda Periodic Safety Update Reports - downtfiles (weebly.com)

4. Periodic safety update reports (PSURs) | European Medicines Agency (europa.eu)

5. Guidance Document - Periodic Benefit-Risk Evaluation Report (PBRER) International Conference on Harmonisation (ICH) Topic E2C(R2) - Canada.ca

6. E2C (R2) Step 5 Periodic benefit-risk evaluation report (PBRER) (europa.eu)

                                                                                                            Name: E. Tejaswini

                                                                                                            Qualification: Pharm D Intern

                                                                             Student ID: 213/1222

                                                                             Email ID: tejachowdary56789@gmail.com