Sent:	February 26, 2018 3:13 PM
To:	rcd-dcmr
Subject:	Making Available EMA's Medical Literature Monitoring 
Service for Small & Medium Sized Canadian Companies



In September 2015, the European Medicines Agency (EMA) launched the Medical 
Literature Monitoring Service for companies that hold  EMA  issued  marketing  authorizations. The need for the service became 
apparent  when a large  number of companies were submitting reports of literature 
searches duplicating data on same products to meet pharmacovigilance requirements, a 
practice that was very costly and unduly onerous for small and medium sized companies.

EMA believes that by reducing duplication of reporting from multiple pharmaceutical 
companies, the initiative will improve the safety monitoring of medicines by 
enhancing the quality and consistency of data reported in EudraVigilance. We are 
convinced the same benefits could accrue if our and, in general, small and medium 
sized companies were granted access to the EMA’s Medical Literature Monitoring 
Service to meet their pharmacovigilance requirements.

We are seeking Treasury Board’s assistance for being granted such access which would 
go a long way in simplifying the task and cost of individually carrying out the literature 
search on each of their products. Of course, companies would still have to carry out 
searches on products not listed in the Monitoring Service, produce annual reports and 
undertake risk assessments. Ideally, such access would be granted to a single 
organization, Post Marketed Products Directorate or an association such as ours and the 
information made available to all DIN holders.

Should this initiative become reality, it would save precious sums to be reallocated to the 
development of new drug products.


 
Pierre Morin
Directeur général-adjoint, GPIM
Nouveau!   www.gpim.org