Summary of Module X – Additional monitoring

Module X – Additional monitoring

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, V, VI VII and IX in previous blogs.

This module describes the requirements for medicinal products that are subject to additional monitoring.

These medicinal products will be readily identifiable by an inverted equilateral black triangle as stipulated in the Implementing Regulation (EU) No 198/2013. 

That triangle will be followed by an explanatory statement in the summary of product characteristics (SmPC) as follows: “This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.”

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 participate, perform and/or review such products.

Reference:https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-x-additional-monitoring_en.pdf

1. Why additional monitoring is needed?

For products whose safety profile is not established, collection of ADR remains primary source to know risk profile of product. Additional monitoring will enhance the reporting, collection and analysis of adverse event data to establish so.

2. When is additional monitoring is requested?

Agency /NCA at the time of granting marketing authorization. Later in lifecycle of product when any new risk emerges and this requires additional monitoring. Usually for new active ingredient, biological product and products that require PASS. Detailed guidance on which product mandatorily require additional monitoring and which are optional are mentioned in module. Usually once the product is included in the list, it will be for 5 years. unless otherwise specified by Agency in consultation with PRAC.

3. How is it done?

Agency/NCA will publish the list of medicinal products that require additional monitoring. PRAC recommendation is also taken especially in optional situations. MAH is required to maintain the black triangle warning on their SmPC. MAH will then continue to monitor this products and any change is notified to NAC/AGENCY for further actions/confirmation.

This module helps understand the requirements of additional monitoring.

Written by:

Dr.Shraddha Bhange.

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