Others

Romania to join the Common Repository to receive Centralised Procedure submissions

Romania will join the Common Repository to receive Centralised Procedure submissions from 1st January 2015. The majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository […]

eCTD submission

Australia (AU-TGA) Now Accepts eCTD Without Paper Copies

Prescription medicine sponsors can now submit dossiers to the TGA (Therapeutic Goods Administration) in the electronic Common Technical Document (eCTD) format. Paper dossiers are no longer required to accompany eCTD formatted submissions, following the success of the pilot programme between January and June 2015. Paper dossiers are also not required to accompany Non-eCTD electronic Submissions […]

eCTD submission

Periodic Adverse Drug Experience Reports (PADERs) submit in an electronic format

FDA issued a final rule on June 10, 2014, that requires industry to submit postmarketing safety reports in an electronic format. The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic products, which includes individual case safety reports (ICSRs) […]