Telematics strategy of the different Regulatory Authorities is having an increasing growth.
Today we’re going to talk about the main e-submission portals.
The mandatory implementation of eCTD as format for human medicinal products is not an initiave in solitude. There are also other parallel implementations which are also worth to mention. One of them are the submission portals of the different Regulatory Authorities, and the advantages of using them, like avoiding burning CDs or DVDs, or avoiding the 1-2 days delay when submitting dossiers by Courier until they reach their destination.
EMA Gateway/Common Repository: Used mainly for submissions to the European Medicines Agency and on the scope of Centralised Procedures, however, it should be also used for some procedures assessed by the PRAC even if the product is a nationally authorised product.
- IT Setup: It´s a one time registration, IT department should be involved on the registration process as is IP address dependent.
During the registration, several information is asked such as the IP address to send / receive acknowledgment back and the creation of a certificate pair (public and private) to send the public part to the agency and install the private one in the gateway in order to ensure the communication is secure.
CESP: Used for submissions of Decentralised, Mutual Recognition and National Procedures.
- IT Setup: This is not a portal but rather a File Transfer Protocol account, IT department should install an sFTP client (such as WinSCP or FileZilla) in order to be able to transfer sequences to the different regulatory authorities
- IT Setup: This registration requires the submission of some simple eCTDs to confirm the technical knowledge of the format, IT department should take care of providing a digital certificate to the user of the portal in order to be able to perform the submissions. The certificate can’t be self-signed, and must have a validity from 1 to 5 years.
Any help you might need with eCTD, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.
Please contact us at eCTD@asphalion.com