Common Electronic Submission Platform
After public consultation, The European Directorate for the Quality of Medicines & HealthCare (EDQM) has laid down its roadmap for the submission of Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) in electronic format for the next 4 years. This roadmap presents a major change to current practices.
The EDQM has decided to use the CESP (Common Electronic Submission Platform) as the more desirable path to get eSubmissions. However, presently the Drop box remains the transfer system most used by applicants.
The EDQM is the organization responsible for the procedure of Certification of Suitability to the monographs of the European Pharmacopoeia (CEP), and therefore receives dossiers describing the manufacture and quality control of substances for pharmaceutical use.
The EDQM has been encouraging the submission of applications in electronic format since 2007 and has provided regularly updated guidance for preparing and submitting eSubmissions (EDQM Guidance for electronic and paper submissions for Certificates of Suitability applications, PA/PH/CEP (09) 108).
Electronic submission roadmap purposes at developing and bettering the current processes for submission of electronic data associated to CEP submissions. The main goals are to have:
- Effective and secure electronic handling of data related to CEP applications (submission, reception, validation, processing)
- Completely electronic processing without paper
- Automation of data transfer and storage
- Alignment with practice in place in regulatory agencies for electronic submission of marketing
Submission media and mechanisms
Receipt and validation of data
Use by assessors
Single format for submission of data: eCTD (except for TSE only submissions and for submissions for substances for veterinary use only).
For TSE only submissions, PDF continues to be standard format accepted.
Single and secure entry point for eSubmission of data: CESP, or alternatively an EDQM dedicated portal.
Implement eApplication form/upload of electronic information from Application form.
Consistent information, aligned with eCTD specification.
Automation of data transfer and storage, reduction of manual handling and checks.
Full use of review tool for all kinds of applications
The detailed actions and estimated timeframes for completion of these actions in order to achieve the objectives described above and which have an impact on the preparation of the submissions by applicants.
|Submission format and content||June-2016 January-2017 January-2018 January-2020||
No further acceptance of paper submissions for any kind of application.
Require eCTD submissions for new applications (except for TSE only submissions and for submissions for substances for veterinary use only). For TSE only submissions PDF continues to be standard format accepted.
Stop accepting PDF submissions for revisions and renewals. Therefore, all such submissions need to be in NeeS or eCTD format (except for TSE only submissions and for submissions for substances for veterinary use only). For TSE only submissions PDF continues to standard format accepted.
Require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only). For TSE only submissions PDF continues to be standard format accepted.
|Submission media and mechanisms||January-2017||Stop use of the Dropbox, CD's and use only the CESP ( or a dedicated EDQM portal)|