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):
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Received Returned back to applicant for completion

Date Signature