Roadmap On Improvements To EMA's Literature Monitoring Service Due By Year End

The European Medicines Agency will be looking for quick wins as well as long-term improvements when it revises its medical literature monitoring service. It will soon publish a roadmap for improving the service with details of when the changes might occur.

The European Medicines Agency is considering a large number of proposals to improve its medical literature monitoring (MLM) service and will issue a roadmap towards the end of this year outlining how and when it will implement the proposals that are accepted. The MLM service has been criticized by industry for failing to meet its key objective of simplifying the monitoring and reporting of adverse events by drug companies.

"Any changes that can be quickly and cheaply implemented, will be done so without delay," said Tom Paternoster-Howe, a scientific administrator at the EMA. Paternoster-Howe was addressing delegates at the Drug Information Association's 10th Annual Forum for Qualified Persons in Pharmacovigilance (QPPV) in London on Oct. 5 and 6.

For other proposed changes, Paternoster-Howe said, the EMA will go over these with marketing authorization holders in a survey due to be undertaken later this month. "In the survey, we will ask simple yes/no questions to know if you want these changes [to the MLM service] and whether it will make things better for you. Also, if we decide to go ahead with the implementation of these changes, how long would you need to manage them… Lastly, we will also ask you to rank the proposed changes [in order of importance]," he added.

An EMA spokesperson told the Pink Sheet that the MLM survey "is currently being finalised and will be launched later this month".

The proposed changes that the EMA is considering including in the roadmap mostly stem from an industry workshop that the agency organized in September after several surveys – conducted both by the industry and the EMA – continually revealed a high level of industry dissatisfaction with the service. The most problematic areas related to timeliness of individual case safety reports (ICSR), the quality of ISCRs and the impact on companies' resources. (Also see "EMA Tackles Complexities Introduced By Literature Monitoring Service" - Pink Sheet, 6 Sep, 2016.)

The latest industry survey, undertaken in April/May this year, covered representatives from the EU generic, R&D-based and self-medication industry associations. It showed that for 76% of the respondents, their literature monitoring activities had become complicated because of the MLM service, said John Barber, QPPV and head of pharmacovigilance (European operations) at Dr Reddy's and a presenter at the DIA conference.

While these surveys had served to highlight the key issues at stake, the EMA organized the September workshop "to understand issues, which weren't crystal clear to us on what was needed," said Paternoster-Howe. The MLM service affects around 6,000 marketing authorization holders and the EMA "wanted to really understand what everyone thinks".

"Rather than rushing in and saying: 'Ok, you don't like this, so how about we do that' And you still don't like it, we figured we would find out precisely what you need… And we did receive a number of recommendations from the workshop. At this stage, we are not endorsing or committing to implement any of them. The EMA is presently analyzing the impact, cost and, if necessary, alternatives [to the industry's recommendations] … The results will be collated and published in the roadmap," he explained.

Nevertheless, Paternoster-Howe pointed out that the EMA has identified "eight highest priority recommendations from the workshop on which we will be paying the most focus". These include:

• Decrease the number of substances covered by the MLM service and extending the scope of the service.
• Search the Medline and EMBASE biomedical literature databases in parallel and excluding any potential duplicates.
• Instead of relying on Excel spread sheets, create a database accessible to marketing authorization holders to search for references and full results of the screening or to provide running cumulative sheets.
• Make it easier to track Excel spreadsheet changes to allow comparison with previous sheets.
• Publish Excel data in RIS Bibliographical format as well as current format.
• Develop a programmable interface to allow automatic searching and download of ICSRs.
• Increase quality assurance resources.
• Establish an advisory/editorial board comprising MAHs and the EMA.

The EU pharmacovigilance legislation places a legal obligation on the EMA to run the MLM service. Under this, the agency currently monitors thousands of medical journals to check for suspected ADRs to 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) and submits relevant valid cases to the EudraVigilance database in the correct E2B format on behalf of the companies. (Also see "EMA to scour medical literature for potential safety concerns from popular drugs " - Pink Sheet, 26 Jan, 2015.)

While the service is available for use by both branded and generics companies, it is more relevant for the generics industry as it covers substances with the greatest number of marketing authorizations.

When the service was introduced, the hope among marketing authorization holders was that it would significantly reduce the burden associated with their literature monitoring obligations. While the service has improved since its launch, the industry believes it is yet to meet its key objectives. (Also see "EMA's Medical Literature Monitoring Service Creates New Complexities For Pharma" - Pink Sheet, 3 Nov, 2015.)

From the editors of Scrip Regulatory Affairs.