The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service. The service was launched in summer 2015, focusing on the top 50 active chemical substance groups. Since last September, the EMA now perform monitoring of medical literature for reports of suspected adverse reactions to medicinal products for 300 active substances and 100 herbals.
The legal basis for the EMA’s task is Article 27 of Regulation (EC) No. 726/2004 which stated that the agency monitor selected medical literature for reports of suspected adverse drug reactions containing certain active substances and to enter individual case safety reports into the EU adverse reaction database (EudraVigilance).
The lists of substances and herbal-substance groups which are subject to the monitoring activities may be found here.
What does this new service mean for Marketing Authorisation Holders (MAH’s)?
The new arrangements mean that MAHs no longer need to enter into EudraVigilance, ICSRs of selected products identified through medical literature searches. This is described in Article 107, paragraph 3 of Directive 2001/83/EC. The molecules that have been selected to date contain those where high numbers of marketing authorisations were granted to various MAH’s in the European community. It is believed that 3,500 MAH’s will benefit from this initially. However, MAHs will need to continue with routine literature monitoring for routine safety surveillance activities in signal detection and periodic reports.
Medicinal products containing paracetamol, ibuprofen, omeprazole, acetylsalicylic acid, ascorbic acid and hydrocortisone are among those substances being monitored by the MLM service. Acorn Regulatory have been providing pharmacovigilance services to many small to medium sized Enterprise’s (SME) for a number of years and we have experienced first-hand, the enormous burden the monitoring and assessment of such molecules in the medical literature has placed on such companies. We have looked at strategies for reducing this burden by open dialogue with multiple MAH’s who have registrations for the same molecules.
The first of the quarterly MLM service reports published last week made for impressive reading, with 100% compliance with the entry of non-serious AEs to EudraVigilance, and between 72-96% compliance with the entry of serious AEs to the database within specified timeframes. We are very pleased to see the launch of the MLM service, and with the improvements that the EMA are making to reduce the administrative burden on the pharmaceutical industry in this area. We hope that the list of substances continues to grow and that all MAH’s will experience this benefit.
We are happy to review how the new updates may affect your PV responsibilities together with advice for any changes you may need to make to your existing system. Please do get in touch with us if you are concerned about these changes or indeed any aspect of pharmacovigilance in Europe. Complete your details below and we will get back to you.
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