top of page

Pharmacovigilance

(Medical Literature Monitoring)

Do I need to monitor medical literature for pharmacovigilance?

​

One of the primary sources of identifying adverse drug reactions is the monitoring of peer-reviewed medical journals and conference proceedings. An essential aspect of the development and marketing of a drug is determining whether the benefits of the drug outweigh any potential harm. For this reason, governmental authorities such as the Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have placed an obligation on drug companies to monitor the medical literature for any adverse reactions associated with their medicinal products.

​

What are the requirements for monitoring medical literature?

​

One of the primary sources of identifying adverse drug reactions is the monitoring of peer-reviewed medical journals and conference proceedings. The FDA requires applicants to report adverse experiences at "quarterly intervals for 3 years from the date of approval of the application, and then at annual intervals." (21 CFR 314.80 - Postmarketing reporting of adverse drug experiences)

​

The EMA stipulates that companies marketing drugs are expected to conduct systematic literature reviews of "widely used reference databases... no less frequently than once a week." (Module VI - VI.B.1.1.2 Literature Reports)

​

Why partner with Mc2 for your medical literature monitoring?

​

  • Databases - Mc2 Research Group has access to the world's leading medical literature databases including Medline, Embase, Biosis, International Pharmaceutical Abstracts (IPA), Elsevier's Scopus, and Chemical Abstracts' STN.

  • Experience - Our researchers have decades of experience in searching these databases and in developing superior search strategies to ensure complete coverage of any adverse effects associated with your drugs.

  • Confidence - Partnering with Mc2 for your medical literature monitoring will provide you with an unbiased, trusted third-party you can count on to meet your information needs.

 

How often should I monitor medical literature for adverse effects?

​

We recommend a weekly monitor of your regulated products.

 

​

bottom of page