Electronic Submission of New Drugs in Europe

Electronic Submission of New Drugs in Europe

A. Susanne Eslinger (Friedrich-Alexander-University, Germany) and Daniela Marschall (Friedrich-Alexander-University, Germany)
DOI: 10.4018/978-1-59140-982-3.ch033
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Abstract

All over the world, drugs and drug applications have to be submitted to and approved by an admission office before they may be sold on the market. All procedures are extensive, time-consuming, and costly. To simplify the process, it could be organised electronically. In an economic perspective, there are many benefits by using the electronic form for the pharmaceutical industry: managing knowledge, cost advantages, and time savings. All, pharmaceutical industry and institutions have undertaken lots of efforts to enforce the electronic solutions. They focus on international standards in order to harmonise structures and processes. It would be necessary to reduce paper and copies, especially if the electronic solution takes place. This method will simplify the way to deal with data and documents and reduce process time and costs.

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