Mandatory use of the XML file for all PSUR submissions from 1 Sep 2015
EMA announced that from 1 September 2015, the use of the XML delivery file for all PSUR submissions via the eSubmission Gateway and/or the Web Client will become mandatory. After this date, it will no longer be possible to submit PSUR submissions using the existing filenaming convention. The mandatory use of the PSUR XML delivery file is introduced to harmonise the submission mechanism for all PSURs and it will apply to all types of PSUR and PSUR supplementary information submissions.
The EMA's strategy for the electronic submission of applications aims to improve efficiency and decrease costs for applicants. In January 2015, the EMA introduced the use of the XML delivery file for PSUR submissions via the eSubmission Gateway and the Web Client as the first step of the phased implementation for a XML delivery file system for all types of submissions via the eSubmission Gateway and /or the Web Client.
This PSUR XML delivery file replaces the existing filenaming convention, which is currently used to provide additional ‘metadata’ allowing the EMA to automatically validate and process submissions. The XML delivery file creation screen has built in validation rules and guides the MAH in the preparation of the submission package, hence reducing errors in the submission process and leading to faster availability of submissions by the network.
The use of the filenaming conventions for other procedure types will remain for the time being; however it is planned that the use of the XML delivery file will be extended to all types of submissions via the eSubmission Gateway/Web Client in future.
Also, PSUR Repository version 01.01 is now available for MAH and NCAs. This release provides change requests enhancing the system and fixes defects identified after the UAT or since the start of the pilot phase.
Regulatory Operations | Regulatory Information Management | Manager - Regulatory Submissions Management at GE Healthcare | PDx Team | Project Management |
9 年package will be the same but the backbone should be XML thats it.
Regulatory operations - Information Management and Systems
9 年Hi Prathiush... An additional XML delivery file should be included along with the submission package. The Agency has developed a dedicated user interface for the creation of the Repository specific XML delivery file. This delivery file can be used to provide the required metadata allowing the EMA to process the PSUR.
Deputy General Manager & eCTD Submission Coordinator
9 年Hi Putin..Thanks for sharing this valuable information.. Do we need to convert entire PSUR into XML format. If so it will be a time consuming process. Can you give an update on it.
Senior Regulatory Specialist at Fresenius Kabi USA LLC.
9 年Thanks for sharing Punit