eSubscription is the process of registering medicinal products for marketing authorisation at the local authorities. eSubscription requires in current regulations in the US and Europe substantially different technologies, terminologies and vocabularies for registration of medicinal products. In the US, the FDA requires a “Structured Product Labeling” (SPL). In Europe, the European Medical Agency (EMA) initiated […]
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Lot Distribution Report LDR In US under 21 CFR 600.81, marketing authorisation applicants must submit to the Center for Drug Evaluation and Research (CDER), LDRs containing certain specified information every 6 months about the quantity of the product distributed under their Therapeutic Biologic Applications (BLAs). Biologic Lot Distribution Data must be submitted in SPL XML […]
Post-approval cumulative reports of safety with download PSUR List (XLS) here. Periodic Adverse Drug Experience Report PADER in the U.S and PSURs for Europe.