EMA Guidance: Medical Literature Monitoring Service from 1st April, 2024

Enhancements to EMA’s Medical Literature Monitoring Service from April 2024

The European Medicines Agency (EMA) has announced key improvements to its EMA Medical Literature Monitoring (MLM) Service, effective 1st April, 2024. These EMA MLM service updates, based on stakeholder feedback, include daily searches across MEDLINE, EMBASE, AMED, and IPA, with results exportable in RIS and Excel formats. This updated MEDLINE EMBASE literature search pharmacovigilance process ensures streamlined access to safety data across major biomedical databases.

The update aims to streamline pharmacovigilance literature screening for Marketing Authorisation Holders (MAHs). While no new journals are being added, it ensures quicker access to MEDLINE search results and supports accurate detection of Individual Case Safety Reports (ICSR) literature monitoring data.

Significantly reducing duplicated search results and enhancing efficiency, MAHs using the RIS format export EMA literature option will benefit from streamlined downloads without needing to adjust their current journal searches.

MAHs are therefore encouraged to familiarise themselves with the updated export options and may wish to integrate the RIS format into their systems if they have not already. This is an essential step for aligning with Marketing Authorisation Holders (MAHs) EMA guidance and maintaining EMA pharmacovigilance compliance 2024.

In line with their recent communications, the EMA has mentioned they will provide detailed support, including webinars and guides, to ensure a smooth transition. For updates and resources, MAHs should therefore monitor the official EMA Literature Monitoring Page (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medical-literature-monitoring) and participate in upcoming webinars.

PharSafer® will closely review these enhancements to the EMA Medical Literature Monitoring service and provide ongoing updates to ensure our clients are well-informed and prepared for these changes. Learn more about how our PharSafer Services, including specialized Pharmacovigilance Service solutions, Regulatory Strategy Service, and automated reporting with RAPTAR, can keep your operations fully compliant.

For personalised support or questions about how these updates may impact your operations, please do not hesitate to contact us directly.