ROSETTA eCTD Viewer Desktop Edition Download

Windows
Windows 10, 11
Mac
macOS 11.0 or later

Support for eCTD v4.0 with forward compatibility is now available in R7.0 Release Candidate. Contact Us to request a free trial!


Regional Specifications Supported in ROSETTA eCTD Viewer

Region M1 specs versions Windows OS macOS*
Australia 0.9, 3.0, 3.1, 3.2 Yes Yes
Canada 1.0, 2.2 Yes Yes
China 1.0 Yes Yes
Eurasian Economic Union No. 78 Decision** Yes No
European Union 1.0, 1.1, 1.2.1, 1.3, 1.4, 2.0, 3.0, 3.0.1, 3.1 Yes Yes
Gulf Cooperation Council 1.0, 1.1 Yes No
Japan 1.0 Yes Yes
Jordan 1.0, 1.1 Yes No
Singapore 1.0 Yes No
South Africa 1.0, 2.1, 3.0, 3.1 Yes No
South Korea 1.0 Yes No
Switzerland 1.0, 1.0.1, 1.2, 1.3, 1.4, 1.5 Yes No
Taiwan 1.0 Yes No
Thailand 0.9, 0.92, 1.0 Yes No
Ukraine 1.0 Yes No
United States 2.0, 2.01, 3.3 Yes Yes
West African 1.0 Yes No
World Health Organization 1.0 Yes No

Note:

* Support for eCTD specifications from other regions in the Mac Edition will be included in the next version.

** No. 78 Decision:(5.29.2024)Решение Совета ЕЭК от 03.11.2016 № 78 "О Правилах регистрации и экспертизы лекарственных средств для медицинского применения".