Standard Operating Procedure for Regulatory Submission and Filing

1) Purpose

This SOP outlines the procedures for preparing, submitting, and filing regulatory documents to regulatory authorities for approval of pharmaceutical products.

2) Scope

This SOP applies to all personnel involved in regulatory affairs, including regulatory affairs managers, regulatory affairs specialists, and other relevant personnel responsible for preparing and submitting regulatory submissions.

3) Responsibilities

The Regulatory Affairs Manager or designated personnel are responsible for overseeing regulatory submission activities. Regulatory affairs specialists are responsible for preparing, compiling, and submitting regulatory documents in compliance with regulatory requirements.

4) Procedure

4.1 Pre-submission Activities

1. Review and interpret regulatory guidelines and requirements applicable to the specific submission (e.g., new drug application, marketing authorization application).
2. Coordinate with cross-functional teams (e.g., clinical, quality, manufacturing) to gather necessary documentation and data for submission.

4.2 Document Preparation

1. Prepare regulatory submission documents, including the application form, drug master file (DMF), clinical study reports, quality control data, and any other required documents.
2. Ensure all documents are accurate, complete, and formatted according to regulatory agency requirements.

4.3 Submission Strategy

1. Develop a submission strategy timeline, including milestones for document preparation, review, and submission.
2. Ensure alignment with regulatory agency timelines and expectations for review and approval.

4.4 Submission Process

1. Compile all required documents into a submission package and organize according to regulatory agency specifications.
2. Submit the regulatory dossier electronically or in hard copy as per regulatory agency requirements.

4.5 Post-submission Activities

1. Monitor the progress of the regulatory submission and respond to any queries or requests for additional information from regulatory authorities.
2. Coordinate with regulatory agencies during the review process and provide any requested clarifications or supplementary data.

4.6 Approval and Filing

1. Receive and review regulatory approval or feedback from regulatory agencies.
2. File approved regulatory documents and maintain regulatory submission records in accordance with record retention policies.

5) Abbreviations, if any

SOP: Standard Operating Procedure
DMF: Drug Master File

6) Documents, if any

Regulatory Submission Checklist, Application Forms, Clinical Study Reports, Quality Control Data, Correspondence with Regulatory Agencies, Approval Letters

7) Reference, if any

Regulatory guidelines and requirements specific to the jurisdiction(s) where submissions are made, such as FDA Guidance Documents, EMA Guidelines, and ICH Guidelines.

8) SOP Version

Version 1.0