Standard Operating Procedure for Regulatory Submission for Transdermal Patches
1) Purpose
To establish procedures for preparing and submitting regulatory documents for transdermal patches, ensuring compliance with regulatory requirements for marketing authorization.
2) Scope
This SOP applies to regulatory affairs personnel responsible for preparing and submitting regulatory submissions for transdermal patches, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and marketing authorization applications (MAAs).
3) Responsibilities
3.1 Regulatory Affairs Manager: Oversees the preparation and submission of regulatory documents.
3.2 Regulatory Affairs Specialist: Prepares and compiles regulatory submissions according to regulatory guidelines.
3.3 Quality Assurance (QA): Reviews regulatory documents for accuracy and completeness.
3.4 Project Manager: Coordinates timelines, resources, and documentation for regulatory submissions.
3.5 Legal Affairs: Provides legal review and approval of regulatory documents as necessary.
4) Procedure
4.1 Pre-Submission Planning:
4.1.1 Initiate regulatory strategy meetings to define the scope and timeline for regulatory submissions.
4.1.2 Identify required documents and data to support the regulatory submission.
4.2 Document Preparation:
4.2.1 Compile and organize all necessary documents, including clinical trial data, analytical reports, and manufacturing information.
4.2.2 Ensure documents are formatted according to regulatory guidelines (e.g., eCTD format).
4.3 Submission Assembly:
4.3.1 Create electronic and/or physical copies of the regulatory submission package.
4.3.2 Include all required forms, cover letters, and supporting documents as specified by regulatory authorities.
4.4 Submission to Regulatory Authorities:
4.4.1 Submit the regulatory package to the appropriate regulatory authorities via electronic submission portals or physical mail.
4.4.2 Track submission progress and address any requests for additional information or queries from regulatory authorities.
4.5 Post-Submission Activities:
4.5.1 Monitor and communicate regulatory approval status to stakeholders.
4.5.2 Archive and maintain records of all regulatory submissions and communications for future reference.
5) Abbreviations, if any
SOP: Standard Operating Procedure
NDA: New Drug Application
ANDA: Abbreviated New Drug Application
MAA: Marketing Authorization Application
eCTD: Electronic Common Technical Document
6) Documents, if any
Regulatory Submission Package
Clinical Trial Data
Analytical Reports
Manufacturing Information
7) Reference, if any
ICH ECTD Specifications
EU Guidelines for Marketing Authorisation of Medicinal Products
FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
8) SOP Version
Version 1.0
