Standard Operating Procedure for Regulatory Submission for Aerosols
1) Purpose
The purpose of this SOP is to define procedures for the preparation, compilation, and submission of regulatory documents related to aerosol products. This ensures compliance with regulatory requirements and facilitates the approval process for marketing authorization.
2) Scope
This SOP applies to all regulatory submissions for aerosol products at [Company Name], including new drug applications (NDAs), abbreviated new drug applications (ANDAs), investigational new drug applications (INDs), and variations.
3) Responsibilities
Regulatory Affairs Manager: Oversee regulatory submission activities and ensure alignment with regulatory guidelines and timelines.
Quality Assurance (QA) Team: Review regulatory documents for accuracy, completeness, and compliance with internal standards.
Clinical Team: Provide clinical trial data and summaries for inclusion in regulatory submissions.
Manufacturing Team: Contribute manufacturing and quality data as required for regulatory submissions.
4) Procedure
4.1 Regulatory Strategy Development:
4.1.1 Develop a regulatory strategy based on product development milestones and regulatory requirements.
4.1.2 Identify regulatory pathways and submission types (e.g., NDA, ANDA, IND) applicable to aerosol products.
4.1.3 Plan submission timelines, milestones, and responsibilities for each regulatory submission.
4.2 Document Preparation:
4.2.1 Compile essential documents, including drug substance and product information, clinical study reports, and manufacturing details.
4.2.2 Prepare summaries and overviews of pharmacology, toxicology, clinical trials, and pharmacokinetics/pharmacodynamics (PK/PD).
4.2.3 Review and update documents based on regulatory guidelines and feedback from internal stakeholders.
4.3 Submission Package Assembly:
4.3.1 Organize and assemble the regulatory submission package according to regulatory agency requirements (e.g., FDA, EMA, Health Canada).
4.3.2 Include all required forms, summaries, data tables, and supporting documents in the submission package.
4.3.3 Label and paginate documents appropriately and ensure consistency and accuracy throughout the submission package.
4.4 Submission to Regulatory Authorities:
4.4.1 Submit the regulatory dossier electronically or in hard copy to the appropriate regulatory authorities.
4.4.2 Track submission status and communicate with regulatory agencies regarding any queries or additional information requests.
4.4.3 Address regulatory agency feedback and provide timely responses to queries and deficiencies.
4.5 Approval and Post-Approval Activities:
4.5.1 Monitor and track the progress of regulatory submissions through approval processes.
4.5.2 Prepare for regulatory inspections and audits by maintaining regulatory submission documentation.
4.5.3 Implement post-approval changes and updates as required by regulatory authorities.
4.6 Archiving and Record Keeping:
4.6.1 Maintain comprehensive records of all regulatory submissions and communications with regulatory agencies.
4.6.2 Archive regulatory submission documents in a secure and accessible manner for future reference and audits.
4.6.3 Update and revise regulatory submission documents as needed based on regulatory changes and product updates.
5) Abbreviations, if any
SOP: Standard Operating Procedure
NDA: New Drug Application
ANDA: Abbreviated New Drug Application
IND: Investigational New Drug Application
PK/PD: Pharmacokinetics/Pharmacodynamics
6) Documents, if any
Regulatory Strategy Document
Regulatory Submission Dossier
Clinical Study Reports
Manufacturing and Quality Data
Correspondence with Regulatory Agencies
7) Reference, if any
FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format
EMA Guidelines on the Requirements for Clinical Documentation for Orally Inhaled Products (OIPs)
ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
8) SOP Version
Version 1.0
