eAF

 eAF is short for Electronic Application Form.

Since 1 January 2016 the eAF is mandatory to use for all new Marketing Authorisation Applications, Renewals and Variations within all procedures in Europe.

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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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EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussel-based trade association founded in 1978 representing the research-based pharmaceutical industry operating in Europe.

Through its membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA represents 1,900 EU companies committed to researching, developing and manufacturing new medical treatments.

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EMA

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.

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EPAR

European Product Assessment Reports (EPAR)