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.
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.
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.
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