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Handbook of Cannabis$
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Roger Pertwee

Print publication date: 2014

Print ISBN-13: 9780199662685

Published to Oxford Scholarship Online: January 2015

DOI: 10.1093/acprof:oso/9780199662685.001.0001

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Development of Cannabis-Based Medicines: Regulatory Hurdles/Routes in Europe and the United States

Development of Cannabis-Based Medicines: Regulatory Hurdles/Routes in Europe and the United States

Chapter:
(p.356) Chapter 19 Development of Cannabis-Based Medicines: Regulatory Hurdles/Routes in Europe and the United States
Source:
Handbook of Cannabis
Author(s):

Alison Thompson

Verity Langfield

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199662685.003.0019

A House of Lords Scientific Committee held in 1998 gave support to the concept of a modern cannabis-based medicine that would follow a complete pharmaceutical development program, with the ultimate intention of gaining a Marketing Authorisation. Development of a medicine based on an extract of cannabis faced the double challenge of not only the standard hurdles of provision of quality and safety data to meet the requirements of step-by-step clinical development, but also the need to obtain appropriate national licenses for carrying out investigations with controlled drugs. The development program for a cannabis-based medicine, through clinical trials to the eventual Marketing Authorisation application, is described.

Keywords:   regulation, regulatory guidance, clinical trial application, Marketing Authorisation application, Decentralised Procedure, Mutual Recognition Procedure, Common Technical Document

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