IDMP Wiki

eCTD

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 of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions.

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IDMP Wiki

eSubscription in Europe and US

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 a new standard called IDentification of Medicinal Products (IDMP). It is most likely that FDA will take-over these standards in near future. IDMP raised the bar significantly by requiring information be sent in specific form for each country and language and coded with an ISO Code.