International Conference on Harmonization-Keeping International Drug Development in Harmony?
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Drug Informarion Jorrrnal, Vol. 35. pp. 369-376, 2001 Pnnted in the USA. All nghts reserved.
Copyright 0 2001 Drug Information Association Inc.
INTERNATIONAL CONFERENCE ON HARMONIZATIONKEEPING INTERNATIONAL DRUG DEVELOPMENT IN HARMONY? CRAIGMCCARTHY, MBA, MRPHARMS,FBIRA Director of Regulatory Affairs, PPD Development, Cambridge, United Kingdom
Back in the beginning of the 1990s the International Conference on Harmonization (ICH) was born with the objective of achieving greater harmonization of technical requirements for medicinal products, through an active process of discussion, debate, and review of science by international experts of the highest caliber. More than I0 years later, this article will review some of the achievements and missed opportunities of ICH in the process of harmonizing requirements and, in turn, harmonizing the way we develop medicinal products to support quality, safety, and efficacy from a regulatory viewpoint. This article will also look at new initiatives recently discussed at ICH such as M5, the Common Technical Document (CTD),and M2, the guideline that deals with the standards required for electronic transfer of regulatoty information to regulatory authorities and how this will effect the way we move the technical reports into regulatory submissions and the subsequent review of these by the regulatoty authorities in the future. Key Words: ICH; Guideline; International; Drug development
INTRODUCTION ONE OF THE MAJOR changes in the last decade to the regulatory environment that impacted on international drug development was the International Conference on Harmonization, which was born in the 1990s. Of course, this unique initiative was largely driven by industry to reduce time and cost in drug development and indeed brought together for the first time the regulatory authorities and experts from the pharmaceutical industry taken from the European Union (EU), Japan, and the United States (1,2,3). The overall objective was to find ways to harmo-
nize technical guidelines and requirements for medicinal product registrations. The pharmaceutical industry wanted to provide a more cost-effective use of human, animal, and material resources and to eliminate unnecessary delay in global development and registration of new drugs, while keeping an appropriate level of quality, safety, and efficacy. The first conference took place in Brussels in 1991, and although termed ‘international’ was only cosponsored by a few of the global players:
Reprint address: Craig McCarthy, MBA, MRPharmS, FBIRA, Director of Regulatory Affairs, PPD Development, Compass House, Vision Park, Chivers Way, Histon, Cambridge, CB4 9AD United Kingdom.
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European Commission (EC), European Federation of Pharmaceutical Industry Associations (EFPIA), Japanese Ministry of Health and Welfare (JMHW), Japanese Pharmaceutical Manufacturers Association (JPMA),
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United States Food and Drug Administration (FDA), and Pharmaceutical Research and Manufacturers of America (PhRMA). However, to compromise, there were a number of o
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