Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸
Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸
Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸
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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