Medical Literature Monitoring and Entering Negative Reaction Reports

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MEDICAL LITERATURE MONITORING AND ENTERING
NEGATIVE REACTION REPORTS
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales_at_pepgra.com
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Today's Discussion
Introduction
OUTLINE OF TOPICS
Service Insights Avoiding Duplication Expected
Outcomes Legal Antecedents Active Substances
Included Advantages of Marketing Authorization
Holders
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Introduction
A novel process where European Medical Agency
offers a new service. The service is focused
around medical literature monitoring. This
service is also a vital step to ensure that there
is no duplication of negative reaction
reports. This service came into effect from
1st September, 2015.
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Service Insights

• The European Medicines Agency (EMA) on 12th May,
  2015 presented an official intimation of medical
  literature monitoring service.
• A preset array of journals and reference
  databases would be utilized for this service.
• EMBASE
• EBSCO - The primary focus would rest on the usage
  of
• Medline Plus
• International Pharmaceutical Abstracts (IPA)
• The Allied and the Complementary Medicine
  Database (AMED)

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Avoiding Duplication
The Good Pharmacovigilance Practices (GVP)
Module VI, organizations have been authorized
for marketing are supposed to monitor medical
literature. They were also expected to notify
about individual instances of alleged negative
reactions from medicines for which they held
marketing authorization within the EEA. The
duplication was in terms of active substances
that could be found in more than one medicine,
as well as duplicate entries regarding such
reports were made into EudraVigilance and
national safety databases.
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Expected Outcomes
Improve the overall efficiency in terms of
reporting negative reactions. Present the
pharmaceutical sector with a simplification. Enhan
ce the overall quality of data by lowering the
scope for duplication. Undertake efforts to
ensure savings in resource for the pharmaceutical
industry. Extend support in terms of activities
pertaining to signal detection by holders
of marketing authorization and national competent
authorities.
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Legal Antecedents
Article 27 of Regulation (EC) No 726/2004 forms
the background for the tasks of the EMA. As per
regulations, it has been stated that Selected
medical literature will be monitored by the
Agency for reports pertaining to suspected
negative reactions to medicinal products that are
inclusive of some specific active
ingredients. The Agency will also publish the
list of active substances that are presently
being monitored and the relevant medical
literature that falls under their purview. An
in-depth guide will be created by the Agency
following due discussions with Member States,
Commission, with regards to monitoring medical
and scientific literature and entering the
required information into the database of
EudraVigilance.
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Active Substances Included
An extensive array of active substances which
also comprises of herbals, have been chosen on
the basis of the medicinal product information
that has been provided to the EMA in tandem with
Article 57(2), in the second paragraph of
Regulation (EC) No 726/2004. The detailed list,
largely of chemicals and substance groups which
were herbal and subject to being monitored by
the Agency is available in a separate document
on the Agency website.
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Advantages of Marketing Authorization Holders

• The introduction of this new service by the EMA
  is bound to make a humungous positive impact
  mainly on marketing authorization holders who
  exist and operate in the EEA.
• As per estimates, around more than 3,500
  marketing authorization holders for substance
  groups stand to gain from this service.
• In addition, marketing authorization holders in
  excess of 640 under the herbal substance group
  would also stand to gain an advantage through
  this move by the EMA.

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