eCTD Glossary

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Entries 1 to 11 of 11

E:
eCTD
Electronic application form
Electronic signature
Envelope
ESTRI
ETICS
ETIG
EUDRALINK
EURS
EVMPD
EVPRM
 
Electronic application form
The electronic application form specification has been developed by regulators and TIGes/Interlinking Group to provide a European standard for the eclectronic exchange of structured administrative information contained in the application form for a) new applications, b) variations, or c) renewals of medicinal products in the European Community between the Industry and European Regulatory Authorities. The file format of the electronic application form is XML which is validated via a DTD.
 



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