Solutions

Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material. The entire process involves near-constant correspondence between Regulatory affairs departments and the global Health Authorities (HAs).

The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now.  EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.