CTD PRE-SUBMISSION SCREENING CHECKLIST 2019

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 Profile (where applicable) along with evidence of purchase of reference product	Yes	No
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 drugs)	Yes	No
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