The European Medicines Agency (EMEA) has issued a reminder that the Electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from 1 January 2010.
The European Medicines Agency (EMEA) has issued a reminder that the Electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from 1 January 2010.
The agency believes that the action will help it to eliminate the burden of processing paper dossiers, as well as provide several advantages, such as the automation and standardization of administrative duties, a reduction in management and archiving costs, and improvements in the ease of access and assessment of data. Using the e-CTD format as opposed to other formats will also help to harmonize the regulatory process.
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The mandate is part of the EMEA's phased introduction of e-CTDs into the centralized procedure. The agency first began accepting electronic-only submissions, with no additional requirements for paper copies, in July 2008, and on 1 January 2009, the EMEA strongly recommended that all submissions be electronic.
