Summary of Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products

 Summary of Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products

Continuing the series on Guideline on good pharmacovigilance practices, in this blog i will jump right into module VI having covered module I , II, III, IV and V in previous blogs.

This module describes the ICSR requirements.

Overall, the module does go in more and clear details on expectations and its best to read module thoroughly and completely when one has to collect, process, analyze and submit ICSRs.

1. Definitions in ICSR : When we are processing cases, we are confused on requirements, going back to basics and looking at definitions helps. Definitions are provided for Adverse drug reaction, seriousness criteria special case scenario e.g. misuse, abuse, medication error, lack of efficacy etc.

2. Processing of ICSR : The requirements of ICSR processing, including identifying correct source type i.e. solicited, unsolicited. Type of cases and its requirements spontaneous, literature and clinical trials.

3. Submission of ICSR: Submission format, content and timelines are provided.

"The submission of serious valid ICSRs is required as soon as possible, but in no case later than 15 calendar days after initial receipt of the information by the national or regional pharmacovigilance centre of a competent authority or by any personnel of the marketing authorization holder, including medical representatives and contractors. This applies to initial and follow-up information." ICSR can be submitted electronically and follows ICH guidelines.

4. Nullification of ICSR: This is when the case is created erroneously then a follow up will eb submitted notifying EMA and then nullified.

5. Amendment of ICSR: When a previously submitted ICSR has to be corrected (without getting follow up) then amended ICSR should be submitted. The amended fields should impact the meaning of case i.e. seriousness, listedness, company comment, causality etc.

Reference:https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-and-submission-reports-suspected-adverse-reactions-medicinal-products-rev-2_en.pdf

Written by:

Dr.Shraddha Bhange.

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