ICH guidelines- Summary of E2F 
DSUR

Any PV professional aiming to work in or already working in PV has to be aware on how to navigate and use the ICH  guidance documents. The PV professional who has to write, review or compile a DSUR is supposed to know the DSUR guidance from ICH on finger tips.

• MAH (marketing authorization holder) are asked to prepare DSUR for a fixed period of time for each drug or active substance by health authorities for investigational products.

• A single DSUR from each investigational drug which should suffice to give complete information on evolving safety profile of drug . This will also help regulators to have only one report to review,  consistency in companies will be achieved and will also decrease number of reports generated.
• DSUR will mainly be focused on clinical trials of investigational drug (vaccines and biologics inclusive). The DSUR should also include other finding that can be beneficial in adding about safety profile or benefits of drug.
• DSUR should also include about comparators whenever needed in safety profile discussion about the investigational drug in case of comparison studies.
• A single DSUR can be submitted by MAH for all indications, dosage and intended population for that investigational drug.
• MAH are supposed to submit DSUR as annual report starting from the developmental international birth date which is the date when the MAH got first authorization to conduct trial in any country.
• MAH are required to submit DSUR to regulatory authorities and in addition if requested by ethics committee or institutional review boards.
• The document used for labeling i.e reference safety information is investigators brochure(IB), which if not available can be replaced by local product label.
• DSUR should also emphasize on any other trials data if available other than their own MAH sponsored trials, non clinical data, data from literature, spontaneous reports.

• DSUR should also have data on lack of efficacy, region specific AE or ADR.
• DSUR should conclude with overall safety, any changes in reference safety information, any change in safety action plan etc.
• The information in DSUR should also cover ongoing risks and any resolved risks.

The content of DSUR is off Course available on ICH guidelines.

To sum the content are introduction of drug, its worldwide marketing status, actions taken in that period of time of report to cover any safety issues, any changes in reference safety information i.e IB, clinical trial that was undertaken details regarding it if ongoing and completed trial, how many patients/subjects were exposed as in cumulative exposure, line listings and summary tabulations of all ADR (adverse drug reaction ) and SAE(Serious adverse event), any other significant findings from clinical trials and non interventional  studies.

The information in DSUR can form basis of safety specifications and risk management (ICH E2E) that we discussed last blog.

Reference: https://database.ich.org/sites/default/files/E2F_Guideline.pdf

  

Written by:

Dr.Shraddha Bhange.

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