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EMA Yearly Update on MLM – highlights and next steps

Posted on January 19th, 2016 by in Pharmacovigilance


EMA  Pharmacovigilance Programme Update Issue 6 – Preparing for Business Change

Since July 2014, EMA provides quarterly Pharmacovigilance Programme Updates to Marketing Authorisation Holders (MAHs). The purpose of these Updates is to inform MAHs on the development of new systems and services EMA is working on, to support MAHs prepare for business changes.

Systems and Services included in the Pharmacovigilance Programme Updates are medical literature monitoring, database of Medicinal Products (Article 57 database), PSUR Repository, Pharmacovigilance Fees, and adverse drug reaction reporting and Signal Management.

Recently the 6th quarterly Update was published which provided an overview on the highlights so far and the upcoming steps for 2016 for medical literature monitoring and the other sytems and services.

EMA MLM Service- Highlights 2015

  • Launch of EMA MLM Website with some key documents about the monitoring of medical literature.
  • Launch phase MLM service from 1th of July 2015 until 31 Augustus 2015 for the 50 most common chemical active substance groups.
  • Launch of full EMA MLM Service Operation in September 2015. The service now covers 300 chemical active substance groups and 100 herbal active substance groups.

EMA MLM Service – Steps to come in 2016

  • Monthly stakeholder webinars will be organized throughout 2016
  • An independent audit of the service provider’s internal quality management and control systems and of the output of the service will be conducted in early 2016 (and 2-yearly thereafter)
  • Customer satisfaction surveys will be performed in 2016
  • A quarterly service update report will be published on the dedicated MLM website
  • Other key documents will be updated as needed including: search strategies, the list of active substances, list of journals, and the user manual.

What should MAHs do?

In addition to 2015 Highlights and next steps for 2016, the 6th Pharmacovigilane Programme Update also outlines once more what is expected from MAHs. MAHs are not required to report suspected adverse drug reactions from EMA MLM Service to Eudravigilance, if its product contains one of the active substances on the list of EMA MLM Service.

Companies are advised to review the list of active substance groups and to check whether their products are part of the EMA MLM Service. In addition, MAHs may need to check the reference to the journals that are part of the EMA MLM Service, in order to check whether all journals/databases that are relevant for their products are part of the EMA MLM Service.

However, MAHs are required to report all adverse drug reactions from medical literature that is not covered by the literature reference databases and journals from the EMA MLM Service. This means that MAHs still need to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorization.

Furthermore, as also described in this week’s blog post, Monitoring literature for Benefit-Risk Evaluation: a Life-Time Responsibility , MAHs do not only need to monitor scientific literature for identifying single adverse drug reactions. They periodically also need to review literature systematically to evaluate the benefit-risk balance.
Related Blog Posts on Pharma R&D Today:

Are we expecting too much from the EMA’s MLM service?

Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?

EMA’s Medical Literature Monitoring: Shakedown or Shakeup


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