Post-Approval Change Submissions - Overview
To enhance productivity and optimize operational costs, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any changes in the registered content of medicinal products including those related to Post Approval Regulatory Affairs, should be submitted to the respective Health Authority (HA) per the appropriate submission procedure with supporting data before its implementation. Based on the impact of the change, the prior approval requirements would be determined about the CMC post-approval change submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval change submission is significant.
Freyr’s CMC Regulatory Affairs team has experience and expertise in handling the following CMC post-approval change submissions to and the competent HAs based on country-specific requirements.
Furthermore, Regulatory Compliance Associates offer post-market surveillance, Post Approval Regulatory Affairs services, Post-Approval Submissions and Lifecycle Maintenance, ANDA Post-Approval Changes, and various other services to maintain compliance with Regulatory requirements.
Post-Approval Change Submissions
- Change in the manufacturing site like an addition/deletion
- Marketing Authorization Holder transfers
- Optimization of manufacturing process/change in route of synthesis/change in equipment
- Change in formulation/batch size change
- Addition of new supplier for active substance/CEP updates/new CEP
- Inclusion of additional sources for the starting material of the drug substance
- Post-approval changes to drug substances
- Post-approval Regulatory affairs and services are for maintaining compliance and ensuring the quality, safety, and efficacy of approved pharmaceutical products
- Monograph updates, i.e., CMC Regulatory compliance to pharmacopeia
- Specifications and analytical method changes
- Changes in container closure system and suppliers
- Shelf-life extension/reduction
- Administrative updates/contact details’ changes
- Change controls/proposed changes evaluation
- Provide CMC consulting on the submission strategy for the proposed changes
- Implementation strategy and timelines
- Guidance in supporting documents/data
- Preparation of Supplement/Variation/Amendment Package
- Interaction and follow-ups with Health Authorities for approval and implementation
- CMC Regulatory compliance of legacy dossiers/submissions with post-approval supplements/CMC variations
- CMC post-approval Regulatory affairs
- Support in CMC post-approval changes
- Post-approval Regulatory Affairs and Consultation Services
- FDA post-approval changes submission strategy
- Up-to-date post-approval changes guidelines
- Timely filing of CMC Regulatory submissions
- Post-approval submissions and lifecycle maintenance support
