Masterarbeit

Current Developments in Electronic Regulatory Affairs and Their Impact on Small and Medium-Sized Enterprises

Olof Palme (2012)

Summary
Language: English

Currently there are major proceedings in the area of eRA. Changes in pharmacovigilance legislation bring along the obligation for marketing authorisation holders to report details on their medicinal products to the EMA in order to create the EudraVigilance Medicinal Product Dictionary. Besides eSubmission progresses further by the development of the next major version of eCTD. Finally submission platforms for the electronic submission of regulatory data are available for several authorities of member states as well as for the EMA. All these points influence the pharmaceutical industry as whole as well as pharmaceutical SME in particular.
There definitely is a need for harmonization of the different types of information that are necessary for pharmaceutical companies to report to CA. An integrated submission solution is outlined, combining eSubmission and XEVPRM submission. For the submission, a centralized web-based submission platform is proposed to be created. Such a harmonized and integrated approach of interoperable systems for information handling will lead an easy-to-use and cost effective system which will furthermore improve the quality of data and their content safety in eRA. This is thought to be valuable for the pharmaceutical industry in general and especially for SME, having limited access to financial and human resources. The potential to create safe systems for data management, easy submission of regulatory information and central data storage will make this appealing from an economical point of view and thus efforts in the development of standards is a beneficial investment also for SME.

Pages: 26, Annexes: pages: 0