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CTD Checklist Dummy

This document outlines the pre-submission screening checklist used by the Drug Regulatory Authority of Pakistan to determine if an application for drug evaluation and registration is complete. The checklist ensures that required documents like the application form, fees, manufacturing licenses, summaries, stability data, and additional documents for imported or contract manufactured products are included. If any required documents are missing, the application will be returned to the applicant for completion.

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824 views1 page

CTD Checklist Dummy

This document outlines the pre-submission screening checklist used by the Drug Regulatory Authority of Pakistan to determine if an application for drug evaluation and registration is complete. The checklist ensures that required documents like the application form, fees, manufacturing licenses, summaries, stability data, and additional documents for imported or contract manufactured products are included. If any required documents are missing, the application will be returned to the applicant for completion.

Uploaded by

daizhussain004
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Government of Pakistan

Ministry of National Health Services, Regulations & Coordination


Drug Regulatory Authority of Pakistan
Division of Pharmaceutical Evaluation & Registration

CTD PRE-SUBMISSION SCREENING CHECKLIST


Note: Application shall be received for detailed evaluation if all the below mentioned documents
are submitted.

Complete Form 5-F along with commitments attached: Yes No


Requisite fee submitted: Yes No
Valid DML / DSL is attached: Yes No
Sectional approval letter is attached: Yes No
Valid GMP inspection report is attached: Yes No
Evidence of international availability in RRA is provided: Yes No
All summaries are provided in Module-2 instead of referring to Module 3: Yes No
For Module-3, in Drug Substance part:
3.2.S.2: Manufacturer(s) along with evidence of local purchase / import: Yes No
3.2.S.7: Stability data of 3 batches as per zone IV-A: Yes No
For Module-3, in Drug Product part:
3.2.P.2.2.1: Pharmaceutical Equivalence through Comparative Dissolution Yes No
Profile (where applicable) along with evidence of purchase of reference product
3.2.P.3.5: Process validation and /or evaluation Yes No
3.2.P.5.3: Validation of analytical procedures (in case of non-pharmacopoeial Yes No
drugs)
3.2.P.8.3: Stability data Yes No
FOR IMPORTED PRODUCTS (Following additional documents)
Original, legalized and valid CoPP / Free sale and GMP certificate Yes No
Sole agency agreement / authorization letter Yes No
Credentials of the manufacturer / site master file Yes No
FOR CONTRACT MANUFACTURING (Following additional documents)
Contract manufacturing agreement Yes No
Details of already approved products for contract manufacturing Yes No
Remarks (if any):
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________

Received Returned back to applicant for completion

Date Signature

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