Regulatory affairs database
Regulatory affairs website
The TREAT-NMD Regulatory Affairs Database is a valuable source of advice to people who are involved in the planning of mono- or multi-centre clinical trials within different European countries.
The current version contains the contact addresses of national authorities as well as national legislation and documents from 15 European countries.
Additionally, European regulations and other important international documents and guidelines are provided (e.g. from ICH and EMEA).
Co-operation between the ECRIN network and TREAT-NMD has been agreed upon via a memorandum of understanding. This agreement will facilitate updating of country specific information on a regular basis along with additional content from more countries.
ECRIN is a EU funded non-profit infrastructure, supporting multinational clinical research projects in Europe.
The database is open for public use and can be accessed online, a login/username is not required:
If you can provide the CTCC with valuable sources of information or contact persons regarding the legal regulations in your country please contact us. We also welcome any technical suggestions. Your help would be very much appreciated and further accelerate the development of this valuable database.
For technical issues please contact Adrian Tassoni
For content please contact Sebastian Geismann