Spring Intro 2023

 Make initial MA applications as flexible as possible  Allow for optimal planning and resources – be realistic! Lifecycle Management CMC – Lessons Learnt

 Understand the change for appropriate development of submission strategy  Establish strong cross-divisional team and transparent communication lines  Understand and apply the Variations Rules and Guidances in each country/territory  For the EU take great care  With categorisation & conditions (Type IA/IB/II)  Also for grouping changes and the use of worksharing  Prepare high quality variation applications, but keep it simple  Implement changes at right time  Keep close relationship with the Regulatory Authorities

The Organisation for Professionals in Regulatory Affairs

39

Future Lifecycle Management Considerations

 The full impact of ICH Q12 will likely take some time to become fully evident but it was set up specifically make lifecycle management easier. Main sections of the Q12 guidance include: ● Established Conditions ● Post-Approval Change Management Protocols ● Product Lifecycle Management Document ● Pharmaceutical Quality System and Change Management  The European Commission are actively working on re-examining the current pharmaceutical legislation  Increasing focus on globally aligned reviews and reliance approvals – accelerated due to COVID-19 pandemic

The Organisation for Professionals in Regulatory Affairs

40