The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory...

Medical Devices announced that it would accept pure electronic filings (eCTD or NeeS) from mid-February 2010 onward (previously a full paper copy was...

the Food and Drug Administration in the Philippines. The PhMDA has been eCTD compliant at least since December 2017. Among other things, the agency is...

FDA would like to implement RPS as the next iteration of eCTD. The idea behind RPS and ICH’s eCTD is the same—the use of a standardized format for regulatory...

requirements. Clinical Data Interchange Standards Consortium Clinical trial eCTD Harmonization in clinical trials Junod, Valerie (2005). Clinical drug trials...

acknowledged at all times. ICH website Analysis: New ICH M2 Requirements into eCTD NMV (=RPS) ANVISA, Brazil BIO EC, Europe EFPIA FDA, US Health Canada, Canada...

mentioned in conjunction with the electronic Common Technical Document (eCTD). A CPP is issued for a single product, because manufacturing arrangements...

reformulation. Kathie Clark (June 30, 2009). "DIA Update: News from the FDA". The eCTD summit. Graham, Stuart J. H.; Higgins, Matthew J. (16 October 2009). "Balancing...

industry. The ICH has developed the electronic Common Technical Document (eCTD) to promote harmonization of regulatory submissions in electronic format...

[when?] its electronic version – the electronic Common Technical Document (eCTD). The application is filed with the regulator, which can be either an independent...