| EMEA |
Guidelines,
press releases, EPARs, position papers, discussion forum etc |
| Eudralex |
"The
Rules Governing Medicinal Products in the EU" - EU Directives, Regulations,
Notice to Applicants etc |
| FDA
(homepage) CDER
(drugs)
CBER (biologics) |
Includes
links to all US legislation and guidelines etc |
| CDER
Drug Approval Application Process |
This
site provides a summary of what you need to know to file applications for
an IND, an NDA, or a generic drug. |
CDER
Drug Application Regulatory Compliance |
This
web page provides links to resources to help drug manufacturers comply
with the Current Good Manufacturing Practice regulations. |
| ICH |
Guidelines,
status of topics, background information |
| WHO |
Press
releases etc |
