The mandate from EMA is that no paper submission should be submitted to any regulatory agency within EU after January 1, 2010 for the centralized Procedure that includes EMA, Rapporteurs and all CHMP members.
The Navitas pharmaREADY eSubmissions team provides extensive experience in eSubmissions consulting for any submission made in the context of a centralized application procedure and the subsequent maintenance of the lifecycle of the application including:
- Initial application
- Supplementary information
- Follow-Up Measures (FUMs)
- Periodic Safety Update Reports (PSURS)
Any eCTD submission submitted to EMA should be checked for Technical and Business Validation conformance. The Navitas pharmaREADY eSubmissions team is well versed with checking the correctness of the eCTD submission from both technical (using automated validation tools) and business perspectives (a thorough Quality Analysis performed by in-house scientific and Regulatory Affairs consultants).
The Navitas pharmaREADY eSubmissions team can help customers to meet the key milestones as outlined below in a typical market authorization procedure.
- Initial submission (Day 0 of procedure)
- Response to business validation issues (if required)
- Response to List of Questions (i.e. Day 121 for a new application)
- Response to List of Outstanding Issues (i.e. Day 181, if required)
- Application as agreed at Opinion (i.e. agreed EN product information if changed at CHMP)
- Provision of translations (i.e. Day 215 for a new application)
- Provision of final agreed translations following linguistic review (it is not also required to send interim working versions of the product information before this point as eCTD)
- Decision (i.e. final amended documentation if any changes occur during the Standing Committee phase)
The pharmaREADY eSubmissions team encourages and supports customers wanting to submit test eCTDs, particularly if the applicant has limited experience of producing eCTDs and would like to investigate particular areas of concern to ensure technical validity at the time of formal submission. The test submission process at EMA for the centralized procedure is an informal process, and the Navitas pharmaREADY eSubmissions team can provide pragmatic assistance for the applicant.
The eCTD is indeed an international standard and is also implemented in the US and Canada and accepted by FDA and Health Canada. However, while one of the primary objectives of introducing the eCTD is to facilitate the preparation of applications intended for multiple regions, care must be taken over the adaptation of the submission to meet regional requirements. The Navitas pharmaREADY eSubmissions team carries credible global submission experience across different international agencies, and can help customers adapt to different regional requirements, while at the same time reducing the duplication effort and providing hands-on support.