Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Submission: from paper submissions to RPS ***

Dr. Margarita Muiños Gimeno (Abschlußjahr: 2014)

Summary
Language: English
An essential condition to obtain a Marketing Authorisation for medicinal products is to submit a dossier to the regulatory authorities. Regulatory submissions have evolved enormously in the past 10-15 years, mainly due to the efforts of the International Conference on Harmonisation (ICH) and the implementation of a common format in which to submit regulatory information; the Common Technical Document (CTD). CTDs were initially submitted as hard paper copies, where much of the effort of managing a submission involved the printing and collating the volumes of information. However, with the increasing penetration of informatics in every sphere of life, electronic submissions, such as NeeS (Non eCTD electronic Submission) or eCTD (electronic CTD) submissions, have gained great importance. NeeS applications were the first type of electronic submissions to be filed. Nevertheless, in the EU, NeeS applications were only conceived as an interim solution until the final implementation of eCTD submissions. In addition, many agencies have developed delivery  systems, capable of accepting information from applicants through one portal (such as CESP platform or eSubmission Gateway).
In June 2005, the Regulated Product Submission (RPS) project was born, as a HL7 project, to generate a standard message that is able assist all type of regulated products in the submission purpose. The main advantages of RPS over eCTD v3.2 are/will be the possibility of handling two-way communication between the regulatory authorities and the regulated industry, enabling re-use of documents across applications and providing information about the submission without the need of application forms.
Pages: 47