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Permit to Import Clinical Trial Materials

FDA list of requirements for permit to import clinical trial materials

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: DEPARTMENT OF HEALTH
FOOD AND DRUG ADMINISTRATION

STANDARD REQUIREMENTS FOR ISSUANCE OF
PERMIT TO IMPORT CLINICAL TRIAL MATERIALS

Requirements
Letter of Application

Proof of Payment
Waiver statement

Copy of the approval of the
Clinical Trial Protocol
Copy of the approval of the
Pharmaceutical Data

Copy of the proforma invoice

Copy of previously approved
import permit

Guidelines
Itemized, detailed description of the
clinical trial materials with corresponding
quantity for each approved investigator
per site/ hospital
500 php per request
Indicating that FDA will not be held liable
from any damage or injury arising from
the use of the investigational drug
product.
Includes
the
lists
of
approved
investigators with corresponding site/
hospital
Should include: GMP statement from
manufacturing/Certificate
from
Regulatory Body, Certificate of Analysis,
Stability Data , Manufacturing Data ,
Formulation and Product labeling
Includes proforma invoice per approved
investigators with corresponding site/
hospital
If applicable
 
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