Electronic Common Technical Document eCTD The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). As […]
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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 […]
Global Ingredients Archiving System (GINAS) What is GINAS in relation to ISO 11238 GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances. GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP. […]
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.