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학술대회자료
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한국농약과학회 한국농약과학회 학술발표대회 논문집 KSPS 10th Anniversary International Symposium on Pesticide 2007
발행연도
2007.4
수록면
27 - 34 (8page)

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Crop Protection (CP) products are already highly regulated in nearly all countries. Scientific progress and an increasing public concern over the adverse effects of Crop Protection products result in even more regulations. These new regulations or new assessment schemes usually originate from either the US, the European Union (EU) or Japan and impact the industry by adding costs and risks to the development of new products. However, there are also positive developments for the industry, in particular the effort in some countries to shorten the review timelines for regulatory submissions. This effort is particularly successful in the US and in some EU member states. On the other hand, the revision of Directive 91/414/EEC, that will probably come into force in 2010, is expected to result in much longer registration time lines in Europe. The R&D costs of a new active ingredient have increased considerably over the last 10 years to more than 200 mio USD. Over the last 15 years an area of particular interest to regulators has been ecotoxicology and the costs to generate the necessary data, in that area, have increased markedly. Data protection and data compensation schemes are well developed in the US. The EU data protection system is under review and a new system will be put in place in approx. 2010 when the new regulation replacing Directive 91/414/EEC comes into force. In 1994 major re-registration programmes were started in the US, EU and Japan, currently resulting in the loss about 50% of the active ingredients in the ED. Secondary regulatory hurdles, e.g. PIC listing, and non-regulatory hurdles, e.g. lists created by the food industry are of increasing concern to the Crop Protection industry.

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Introduction
Time to Market for Crop Protection Products
Impact of regulatory trends on crop protection development costs
Data Protection
Re-registration programs
Secondary regulatory and non-regulatory hurdles

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