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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<br />

Administration<br />

การออกใบอนุญาตผลิตยา/วัคซีน<br />

Manufacturing License<br />

• Approval the plant layout<br />

• Pre-licensing Inspection: premise inspection, review<br />

methods, equipment, facilities, production process<br />

and GMP compliance<br />

• Granting the manufacturing license

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