Medical Literature Monitoring and Entering Negative Reaction Reports | Pepgra.com

1. MEDICALLITERATURE MONITORING AND ENTERING NEGATIVE REACTIONREPORTS An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.com Email:sales@pepgra.com

2. Today'sDiscussion Introduction OUTLINE OFTOPICS Service Insights Avoiding Duplication Expected Outcomes LegalAntecedents Active SubstancesIncluded Advantages of Marketing AuthorizationHolders

3. 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 toensurethat there is noduplicationof negativereactionreports. This servicecame intoeffect from1st September, 2015.

4. ServiceInsights The European Medicines Agency (EMA) on 12th May, 2015 presented an official intimation of medical literature monitoringservice. A presetarrayof journals and reference databaseswould be utilized for thisservice. EMBASE EBSCO- The primary focus would rest on the usageof; MedlinePlus International Pharmaceutical Abstracts(IPA) The Allied and the Complementary Medicine Database(AMED)

5. AvoidingDuplication The ‘Good Pharmacovigilance Practices(GVP) Module VI’, organizations have been authorized for marketing are supposed to monitor medicalliterature. They were also expected to notify about individual instances of alleged negative reactions from medicines for which they held marketing authorizationwithin theEEA. 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 safetydatabases.

6. ExpectedOutcomes Improve the overall efficiency in terms of reporting negativereactions. Present the pharmaceutical sector with asimplification. Enhance 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 holdersof marketing authorization and national competentauthorities.

7. LegalAntecedents Article 27 of Regulation (EC) No 726/2004 forms the background for the tasks of the EMA. As per regulations, it has been statedthat; 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 activeingredients. The Agency will also publish the list of active substances that are presently being monitored and the relevant medical literature that falls under theirpurview. 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.

8. Active SubstancesIncluded 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) No726/2004. The detailed list, largely of chemicals and substance groups which were herbal and subject to being monitoredby the Agency is available in a separate document on the Agencywebsite.

9. Advantagesof Marketing AuthorizationHolders 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 theEEA. As per estimates, around more than 3,500 marketing authorization holders for substance groups stand to gain from thisservice. 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 theEMA.

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