MARAS AG
Gewerbestrasse 5
CH-6330 Cham
Switzerland
Tel. +41 41 747 3131
Fax +41 41 747 3130
mail@maras.ch
Gewerbestrasse 5
CH-6330 Cham
Switzerland
Tel. +41 41 747 3131
Fax +41 41 747 3130
mail@maras.ch
© MARAS AG 2009
Electronic Common Technical Document (eCTD) and eSubmission
An electronic submission (or eSubmission) is any submission of electronic information sent by an applicant to an agency in support of a marketing authorisation application procedure.The eCTD as a specific format is an electronic version of the Common Technical Document (CTD). The structure, folder and file names correspond to those of the CTD.
eSubmission in Switzerland
As of January 1, 2010 eCTD submissions will become possible in Switzerland. In a first step, new applications (for example, new active substances, generics, known active substances, new indications, new dosage strength and new dosage recommendations) shall be accepted. Later, other submission types such as variations will also be accepted. The corresponding timelines will be defined by the agency (Swissmedic) until October 2009.
MARAS AG is in close collaboration with companies which file eCTD pilot submissions (official test phase between July and August 2009). By these pilot submissions the applicants and the agency as well take chance of the possibility to gain experience with eCTD submissions in Switzerland.
It is our aim to use these first-hand information for continuously updating and optimizing our services, so that from January 1, 2010 we will be able to offer you effective solutions for the upcoming era of eCTD submissions in Switzerland.
eSubmission in Switzerland
As of January 1, 2010 eCTD submissions will become possible in Switzerland. In a first step, new applications (for example, new active substances, generics, known active substances, new indications, new dosage strength and new dosage recommendations) shall be accepted. Later, other submission types such as variations will also be accepted. The corresponding timelines will be defined by the agency (Swissmedic) until October 2009.
MARAS AG is in close collaboration with companies which file eCTD pilot submissions (official test phase between July and August 2009). By these pilot submissions the applicants and the agency as well take chance of the possibility to gain experience with eCTD submissions in Switzerland.
It is our aim to use these first-hand information for continuously updating and optimizing our services, so that from January 1, 2010 we will be able to offer you effective solutions for the upcoming era of eCTD submissions in Switzerland.