EMA Survey To Gauge Pharma's Satisfaction With Its Medical Literature Monitoring Service
This article was originally published in SRA
The European Medicines Agency is inviting feedback from pharmaceutical companies using its medical literature monitoring service to gauge if they are satisfied with the operation of this new tool, which was created under the provisions of the EU pharmacovigilance legislation to reduce the administrative burden on companies1.
Under the MLM service, the EMA, rather than drug companies, monitors selected medical literature and reports suspected adverse reactions from drugs containing certain active substances. However, instead of simplifying processes, most companies complain that the MLM service has created new complexities as a result of which they have to put in more than double the effort to monitor and report ADRs2.
At the end of February, the EMA launched a "customer satisfaction" survey to gather feedback on its MLM service in which stakeholders can participate until March 21. The survey includes questions on whether: marketing authorization holders find the MLM service proficient; the individual case safety reports or ICSRs (serious and non-serious) are being reported in a timely manner; the quality of ICSRs generated has improved; and marketing authorization holders forward the MLM ICSRs to other foreign regulators.
"We will need to wait for the results to tell you more about how we will use the data to improve the service, as this will depend on the feedback we get," an EMA spokesperson told Scrip Regulatory Affairs. This is the second customer satisfaction survey that the EMA has undertaken in regard to its MLM service. The first survey was conducted in August 2015.
At a recent industry conference*, the head of the EMA's pharmacovigilance department Dr Peter Arlett urged drug companies to offer constructive feedback on the MLM service. He explained that the service has been introduced as a simplification tool for the industry under the pharmacovigilance legislation. If the constant refrain from the industry is that the service "is not working and creating complexities", then the European Commission may consider reducing or discontinuing it altogether, he said.
"However, if the industry says that the service is not optimal, then more resources may be invested in the service to make it better... It's important how you offer feedback," Arlett said.
In addition to the customer satisfaction survey, the EMA is conducting an independent audit of the service provider running its MLM service. The opening meeting for this audit was held in January and it focused on processes, how changes are made, and the operation of the service as a whole, the EMA spokesperson added.
* Peter Arlett, head of EMA's pharmacovigilance department, was speaking at the 9th annual Pharmacovigilance Forum organized by the European Generic and Biosimilar Medicines Association (EGA) on Jan. 27 in London.
References
1. EMA Medical Literature Monitoring Customer Satisfaction Survey (MAH - Q1 2016), Site accessed March 4, 2016, https://www.surveymonkey.co.uk/r/EMAMLMCustomerSatisfactionSurveyMAHQ12016
2. EMA's Medical Literature Monitoring Service Creates New Complexities For Pharma, Scrip Regulatory Affairs, 3 November 2015