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Regulatory Roadmap for the development of human medicinal Products
(Europe focus)

Welcome to the Regulatory Roadmap. This roadmap will help to identify the applicable regulations and guidance* for each phase of the development of Human Medicinal Products. It represents a time-based path through the entire lifecycle of a drug, from initial inception through to distribution and pharmacovigilance of the marketed product.

Just click on the various stages below to reveal the information.

'Non GxP' Research

GLP : Pre-Clinical Research

GMP : Test Article

GMP : IMP Manufacturing

GMP & GCP : Trial Supplies

GCP : Clinical Research
(Phases I,II,IIa)

GCP & GPVP : Pharmacovigilance

GMP : Product Manufacturing

GMP : Distribution

GCP, GMP & GPVP : Post Marketing Studies

*Covers regulations, legislation and guidance within the European Economic Area level, not including national legislation except for the UK.

The Roadmap is an overview generated by the RQA Regulatory Roadmap Working Party and is for guidance only.
Users should ensure that its content is suitable for their particular use.