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