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<strong>Combination</strong> <strong>Products</strong><br />

What is regulatory “harmonization”<br />

• Progressive convergence over time of regulatory<br />

requirements <strong>and</strong> practices<br />

• Progressive elimination or reduction of technical<br />

differences in regulatory requirements<br />

► Facilitates global product development <strong>and</strong> clinical<br />

investigations<br />

18-Oct-06<br />

APEC Tokyo 2006 <strong>Combination</strong> <strong>Products</strong> <strong>and</strong> <strong>Asia</strong>n Harmonization; M. Gropp<br />

43

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