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Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European  Medicines Agency along side interested parties created the Notice to Applicants (NTA). This was through with the target to fulfil the obligations of the commission with regards to article 6 of Regulation ( European Union ) No. 726/2004, and with regards to the Annex I to Directive 2001/83/EC as per the amendments. one among the primary editions of the Notice to Applicants (which is volume 2 within the series “The Rules governing medicinal products within the ecu Union) was initially published within the year 1986.  This notice was subject to further revisions following which a completed version was issued i.e., the second edition was published in 1989(European Commision, 2020). Later, during 1993, the processes associated with applications for marketing authorizations were modified and therefore the mutual also as centralized regulation procedures came into...

During recent times, regulations related to pharmacovigilance services   have concentrated largely on medical literature monitoring (MLM), which is a complex procedure, the scope of which continues to deepen and widen.  Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and will make a serious impact on costs related to health systems. due to its significant implications for public health and safety of patients, regulatory authorities round the world have enforced and put into practice novel legislation s associated with pharmacovigilance in recent times. From a historical standpoint, activities associated with pharmacovigilance largely hinges on undertakings for detection , which is executed on data assimilated from impulsive reporting systems. But since health professionals tend to under-report any adverse drug reactions, the main target of latest legislations are largely on pertinenc...