The obligation to submit drug regulatory information electronically has been continuously extended over the past few years. Initially electronic submission was only mandatory for new marketing authorization applications under the centralized procedure, then it was extended to the DCP/MRP (decentralized / mutual recognition procedure) and to national new marketing authorization applications. As from 1st January 2019, all regulatory life cycle activities have to be submitted electronically in eCTD format.
This also includes all kinds of variations, whether minor or major, all renewal applications, PSUSA submissions, or pharmacovigilance submissions if called for by the authorities.
This is one more milestone in the implementation of the HMA eSubmission Roadmap, which foresees even more electronic functions to be implemented in the next few years.
The regulatory data are submitted in so-called sequences, each starting with sequence no. 0000. Sequences are file bundles managed by an XML file, so that individual documents can be assigned to their right place on the target server and previous document versions can be properly completed, replaced or deleted, if applicable.
These sequences are created by special software systems. GBA Pharma GmbH is of course equipped with such a system and would be glad to create the submission sequences for you – including all preliminary work for submission (variation, renewal etc.).
For existing marketing authorizations, a baseline submission is not mandatory but often helpful and reasonable.
It is not specified which way of submission the marketing authorization holders must use. They may continue to send CDs/DVDs by mail, but the Common European Submission Portal CESP offers a perfect and comfortable way of submission by a simple “drag and drop” operation.
Only parallel imports and standardized marketing authorizations as well as the declaration of renouncement at the end of the life cycle are exempt from mandatory electronic submission.