Post-Approval Changes Submissions

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Overview

Overview

To enhance productivity and to optimise the operational cost, medicinal product manufacturers will 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) by 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 post approval CMC Regulatory submissions (post-approval Supplements/Amendments/CMC Variations) guidelines of respective HAs. In this phase, the importance of the Regulatory strategy for post- approval changes submission is significant.

Freyr’s CMC Regulatory affairs have experience and expertise in handling the following post - approval changes with submissions to respective HAs based on the country - specific requirements.

Freyr Expertise and Advantages

Freyr Expertise

  • 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 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