Global & Local Literature Monitoring
Comprehensive search strategies to ensure your compliance.

What are Global & Local Literature Monitoring?

Literature Monitoring.

Module VI of the European Medicines Agency’s (EMA) Guideline for Good Pharmacovigilance Practices (GVP) stipulates that Marketing Authorization Holders (MAHs) are responsible for actively monitoring medical literature related to their pharmaceutical products weekly and must promptly report any instances of suspected adverse reactions to EudraVigilance.

It is important to note that MAHs are not required to duplicate the monitoring of literature and substances done by the European Medicines Agency (EMA) own Medical Literature Monitoring (MLM) service.

Should the EMA discover any instances of suspected adverse reactions, they will automatically report these to EudraVigilance. MAHs can leverage this information, especially if they are marketing their product outside the European Economic Area (EEA).

Literature monitoring is also applicable to Veterinary Pharmacovigilance and is mandatory for MAHs with veterinary products. The same obligations broadly exist under VGVP as with VGP, but the minimum reporting frequency is annual, or less depending on the risk-based approach.

To ensure compliance with signal management procedures, any detected reports of suspected adverse events must be entered into the EVVet Union Pharmacovigilance Database before the specified “Due date.”

This date aligns with the annually agreed-upon deadline for Marketing Authorization Holders (MAHs) to submit annual statements for each of their authorized Veterinary Medicinal Products (VMPs).

Click for information from the EMA on Good Pharmacovigilance Practices (GVP).

Click for information on the EMA’s Medical Literature Monitoring (MLM) service.

Global vs Local.

Global Literature Monitoring (GLM).

GLM is a comprehensive activity aimed at the entire landscape of suspected adverse reactions research, without regard to its geographical source or originating research institution.

Due to the vast expanse of available literature and the labour-intensive nature of the activity, a specific search strategy using keywords, boolean operators, and terms must be employed to make the identification of suspected adverse reactions and special situations efficient and effective.

Typically, this search is conducted within indexed (catalogued) journals through platforms such as Embase® and PubMed® (Medline).

GLM must be started at the same time a Marketing Authorisation Application is submitted – before the product is permitted to be marketed and made available.

Local Literature Monitoring (LLM).

LLM employs the same search strategy, but it focuses on “non-indexed” local journals specific to individual countries, which are not part of any centralized database or platform.

Identifying and selecting the local journals for search requires careful consideration and consensus on their relevance, with the same objective of efficiency and effectiveness in mind. However, LLM is prone to being influenced by local conditions, cultural factors, and a potentially narrower perspective.

LLM must commence simultaneously with the approval of marketing authorization, and MAHs are obligated to perform LLM irrespective of the product’s marketing status and availability.

Why use Aegisana’s Literature Monitoring services?

Safety insights.

The importance of Literature Monitoring extends beyond regulatory obligations as it serves as a valuable tool for gaining early insights into safety concerns and plays a pivotal role in generating safety and aggregate reports.

Furthermore, it actively supports the Signal Management process and exerts influence over the decisions that shape your product’s benefit-risk profile, ultimately safeguarding the well-being of your patients.

Focused search strategies.

Our team of experts can craft and execute meticulously designed search strategies, ensuring they are efficient and comprehensive. We cover both Global and Local sources, including the EMA’s MLM service, as well as a range of clinical and non-clinical studies pertinent to drug safety and efficacy.

Aegisana is committed to ensuring you remain fully compliant and informed about the cases we detect and report. We have a wealth of experience in working with clients to achieve their objectives through transparency, focus, and communication throughout the process.