To enhance productivity and to optimise the operational cost, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any change to the registered content of medicinal products should be submitted to the respective Health Authority (HA) in the appropriate submission procedure with supporting data prior to its implementation. Based on the impact of the change, the requirement of prior approval would be determined referring to the CMC post-approval Regulatory affairs submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval Regulatory affairs changes submission is significant.
Freyr’s CMC Regulatory affairs team has experience and expertise in handling the following post-approval Regulatory affairs changes with submissions to the respective HAs based on country-specific requirements.
- Change in manufacturing site, 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 source for starting material for drug substance.
- Monograph updates i.e., CMC Regulatory compliance to pharmacopoeia.
- 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 submission strategy for the proposed changes.
- Implementation strategy and timelines.
- Guidance on 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.