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Regulatory Requirements for Investigational Drugs - กระทรวงสาธารณสุข

Regulatory Requirements for Investigational Drugs - กระทรวงสาธารณสุข

Regulatory Requirements for Investigational Drugs - กระทรวงสาธารณสุข

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Thailand<br />

Food &<br />

Drug <strong>Regulatory</strong> Framework<br />

Drug<br />

Administration<br />

• Marketing authorization and licensing activities<br />

• Post-marketing Surveillance including (AEFI <strong>for</strong><br />

vaccine)<br />

• NRA lot release ( Only <strong>for</strong> vaccine)<br />

• Laboratory access<br />

• <strong>Regulatory</strong> GMP inspection<br />

• Authorization/approval clinical trials

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