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 The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic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) […]

General Information

FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) […]

eCTD submission

Common Repository Centralised Procedure submissions

The following National Competent Authorities such as Estonia, Iceland, Liechtenstein, Slovenia are now ready to receive Centralised Procedure submissions via the Common Repository only means no longer accept Centralised Procedure submissions on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally […]

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