The complexity of the regulatory approval process for labels increases with each clinical phase, as patient numbers increase, from 10-20 patients in Phase 1 to 100-200 people in Phase II, to as many as 10 000 patients in a Phase III trial. As many Phase III trials are conducted across an increasing number of countries, the complexity of dealing with multiple regulatory agencies is magnified.

Health CommunicationGibson Research Consultancy8 October 2019IMP, regulatory challenges, regulatory, labelling, AMP, clinical trial, clinical studies, pharma

Investigational Medicinal Product labelling: an overview

Over two-thirds of clinical studies are carried out outside of the USA. It is not unusual for Phase III trials, in particular, to be carried out in over 30 countries across five continents. More study sites outside of North America and the UK and EU region are being introduced each year, including in countries like Georgia and Guatemala.

Health CommunicationGibson Research Consultancy8 October 2019IMP, labelling, clinical trial, clinical studies, NIMP, AMP, Drugs, medicines, pharma, overview

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