Combination Products and Asia Regional Medical Device ...
Combination Products and Asia Regional Medical Device ...
Combination Products and Asia Regional Medical Device ...
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<strong>Combination</strong> <strong>Products</strong><br />
<strong>Combination</strong> products regulatory objectives<br />
• Effective regulation of the combination – taking into<br />
account each contributing attribute<br />
• Risk-based <strong>and</strong> proportionate controls<br />
• Protect patients<br />
• Promote innovation<br />
• Scientifically appropriate assessments<br />
• Avoid repetitive or unnecessary reviews<br />
• Transparency of jurisdiction determinations,<br />
requirements <strong>and</strong> review pathways<br />
• Timely access of patients <strong>and</strong> clinicians to these<br />
important products<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 />
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