Oviya MedSafe supports MAHs with pharmacovigilance obligations related to EMA MLM

Dear Well-wishers,

At the outset, I am delighted to wish you all a very happy and prosperous new year, through this January 2016 edition of Oviya MedSafe’s newsletter!

The beginning of a year is obviously the best time to cherish the previous year’s achievements. For us, 2015 has been a year of qualitative and quantitative expansion during which Oviya MedSafe as a brand became much more recognized in the pharmacovigilance space across continents and also signed up with a considerable number of new clients from different parts of the world to provide end-to-end drug safety services. We saw this harvest in 2015, as a result of our consistent commitment to pharmacovigilance and our persistent hard work over the past four years. I take pleasure in passing on the due credit to my dedicated team of meticulous pharmacovigilance professionals. Of course, I need to thank our clients and business partners too for their co-operation, without which we wouldn’t have come this far so soon.

In 2015, several innovative measures were adopted by different stakeholders of global pharmacovigilance with the intention of streamlining pharmacovigilance practices without compromising on patient safety. One of such ventures was the European Medicines Agency’s Medical Literature Monitoring Service (EMA MLM), which became fully operational from 1st September 2015. The service is in alignment with the guidance in Good Pharmacovigilance Practices (GVP) Module VI. As a component of this activity, EMA screens an aggregate of 400 active substance groups, including 300 chemical active substance groups and 100 herbal active substance groups.

The EMA MLM service is being given as a support to the industry which, for the active substance groups and literature under the purview of the EMA activities, will not be obliged to enter the data on suspected adverse reactions into EudraVigilance. Individual Case Safety Reports (ICSRs) identified by the EMA MLM service are accessible to the Marketing Authorisation Holders (MAH) so they can incorporate them in their drug safety databases and meet their reporting commitments outside the European Economic Area (EEA). The MLM service thus becomes quite significant for the MAHs in the European Union (EU), especially the generic drug marketers, in many ways ranging from reduction of EU literature search liability to avoidance of duplicate efforts & reports.

While it is true that EMA-MLM service reduces the literature search workload of the MAH, it must be remembered that the search covers only 400 products marketed in the EU. This essentially means that literature searches still have to be performed by MAHs in the following situations:

1) The MAH’s list of marketed products in the EU includes those which are not covered by MLM Service;

2) The MAH co-markets the product in other regions (especially the United States), which do not come under the purview of the MLM service; and

3) For identifying cases reporting the usage of products in special situations (pregnancy, lactation, etc) without an adverse event.

Therefore, it is also right in a way to state that the MLM service identifies some opportunity for MAHs to outsource parts of literature search activities. On another note, some generic companies state that their ICSR volumes have increased following the commencement of MLM service. It is relevant to mention here that Oviya MedSafe, with the combined strengths of our Indian operations and our EU presence in letter and spirit, has mature processes and the best practices in place to support any client with our pharmacovigilance services pertaining to EMA’s MLM, including processing of the ICSRs (with electronic reporting to other regions, as appropriate) generated by the MLM service. Should you have any requirements, please feel free to contact us.

Interestingly, the MLM service has become a hot topic of discussion in countries were pharmacovigilance obligations are emerging, since it is evident that literature cases contribute to a great extent to the volume of spontaneous cases. Adopting a system similar to the MLM service could be an effective way of identifying ADRs in countries were the market is dominated by drug manufacturers or distributors who may not have enough resources to perform literature search. Hence, a model like MLM service could be of great advantage to a country that wishes to be pharmacovigilant, provided that it specifically intends to monitor adverse events reported via literature from its own regions in comparison and in contrast with the relevant global numbers.

Although I would be happy to go on about EMA MLM and share my thoughts on it, I realize I have already written quite a lot and maybe it would be better if I re-visit this topic after a few months.

Looking forward to connecting with you again through our February 2016 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

Managing Director & CEO,
Oviya MedSafe
Pharmacovigilance Consulting & Drug Safety Services
Coimbatore, India & London, UK

India Office: +91-422-2444442
UK Office: +44-8452-733839

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