European Directive Information |
| EU Directive on Good Clinical Practice 2005/28/EC The principles of GCP laid down in Articles 2 to 5 of the GCP Directive 2005/28/EC are essentially the same as the International Conference on Harmonisation's ('ICH') principles for GCP. Official Document |
| New EU legislation comes into force All EU member states had to implement the provisions of the new EU pharmaceutical directives into their national legislation on 30th October. Official Document |
| Revised EU Clinical Trials Guidance (Revision 2) now available Revision 2 of the Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial as required by Article 9 (8) of Directive 2001/20/EC has been updated. Official Document |
ICH/GCP Guidelines |
| E6 Good Clinical Practice - ICH April 1996 Last Version of ICH/GCP Guidelines Official Document |
Data Protection Rules |
| Official Website related to the European Data Protection Directives and laws All about this item here. Official Document |
| European Data Protection Directive 95/46/EC The text of the Directive 95/46/EC here. Official Document |
| Status of implementation of Directive 95/46 in all the state members Important to issue country specific informed consents. Official Document |
Previous
Home