Established and successful
In accordance with European and national regulatory requirements, marketing authorisation holders are obliged to regularly review the international literature on substances after reports on suspected cases of adverse drug reactions as well as other information on the benefit-risk profile of their drugs or active substances.
In order to efficiently meet this requirement, we developed a specific literature research service as a pooling project more than 10 years ago. In this context, generally available data relating to active ingredients are used jointly across companies.
We now routinely research and evaluate around 800 active substances and groups of active substances – chemically defined active substances; herbal active substances; homoeopathic active substances – in various databases for more than 100 marketing authorisation holders.
The relevant publications are stored, evaluated and continuously updated in the BPI Service’s own validated literature database. The search results can be easily retrieved via an online portal.
Automatically notifying the client via email when a relevant case is entered into the database ensures that the participants are always informed on a daily basis.
ICSRs, CIOMS forms and “Recommended assessments of drug relation to adverse reaction” can be ordered for published individual cases requiring immediate notification (15-day deadline). In addition, in view of the statutory PSUR creation obligation, a corresponding line listing is offered for download for each individual case to be included in the PSUR.
Studies that should be considered in the PSUR are also entered into the database so that the PSUR can also be created easily within the company.
Medical Literature Monitoring – MLM
The MLM project started by the EMA in 2015 (i.e. the screening of technical literature for selected active substances) entails numerous obligations for the MAHs (e.g. regular screening of the EMA database; consideration of MLM research in the PSUR and signal detection process).
Against this background, we have developed a specific MLM service package as a supplement to the literature research and evaluation tool. This includes:
- Regular screening and filtering of EMA results
- Automatic duplicate check with the results of the pooling project
- Download of the relevant XMLs and provision via email
Would you like to know more?
We are pleased that you are interested in our “Literature research and evaluation / MLM” services. Further information is available at www.psur.de. We would also be pleased to present our working methods in detail to you personally – we look forward to hearing from you.