Regulatory Roadmap for the development of human medicinal Products (Europe focus)
Just click on the various stages below to reveal the information.
Manufacturing Authorisation(s) and product licence granted for the medicinal product.
Common Technical Document (CTD) Dossier
GMP : IMP Manufacturing
The reporting obligations under the provisions on pharmacovigilance for authorised medicinal products are set out in Directive 2001/83/EC and Regulation EC No. 726/2004
Investigational medicinal product (IMP) Manufacturing
Computer Systems Validation
Label and regulatory approval finalised
Sustain and maximise sales by introducing Life Cycle Management (LCM) line extensions
PRMP implemented, strategy for post launch surveillance defined