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Reliance for Post-Approval Changes:
From Pilots to Practice
Summary Report from the DIA Europe 2025 Pre-Conference Workshop
Reliance offers significant opportunities to increase access and reduce the risk of shortages across all regulatory processes. Reliance approaches are increasingly being used for New Authorisation Applications (MAAs), GMP inspections and batch release testing globally, and more recently for Post-Approval Changes. As Post-Approval Changes (PACs) comprise the bulk of regulatory work for all stakeholders, the application of reliance has the potential to be transformative for Health Authorities, companies and patients.
Changes to the registered information of authorised medicinal products are introduced routinely and are critical to prevent supply disruption and continuously improve existing medicines and vaccines worldwide. They are needed to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, improve quality control techniques, respond to changes in regulatory requirements and upgrade to state-of-the-art facilities. However, the complexity of current PAC systems across markets leads to long approval delays (of up to 3 to 5 years for one change worldwide) and is increasing the risk of shortages and hindering innovation.
Following the COVID-19 pandemic, several pilot projects using reliance for PACs have been initiated to increase the speed of regulatory actions, achieve global alignment and focus available resources on important public health matters. Some include company-specific unilateral reliance initiatives, many using EMA as reference agency. Additionally, initiatives by regulatory agencies, such as by South African Health Products Regulatory Authority (SAHPRA) and the Brazilian Health Regulatory Agency (ANVISA), have used reliance to reduce PAC backlogs. These early pilots demonstrate that using reliance for PACs is possible and can lead to successful outcomes with clear resource and time efficiency gains.
Reflecting on the experience gained during the various reliance pilots - how do we move from pilots to a routine practice where reliance becomes the standard practice globally for PACs approved by a reference agency (WLA)?
A DIA Europe 2025 Pre-Conference Workshop brought together regulators from different regions participating in DIA Europe 2025 and industry stakeholders to reflect on the practical experience when applying reliance approaches to PACs more widely. The discussion focused on learnings from recent unilateral reliance pathways using WLA (formerly stringent regulatory authorities) as reference agencies to speed up PAC approval timelines around the world. Continuous dialogue between industry and regulators and stronger collaboration between regulators discussing practical aspects of reliance-based real case examples is of particular importance to drive routine adoption of reliance for PAC, both for CMC, labelling/clinical updates and new indications.
The conclusions from this Workshop have been outlined in the Outcomes Report that can be downloaded below:
Changes to the registered information of authorised medicinal products are introduced routinely and are critical to prevent supply disruption and continuously improve existing medicines and vaccines worldwide. They are needed to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, improve quality control techniques, respond to changes in regulatory requirements and upgrade to state-of-the-art facilities. However, the complexity of current PAC systems across markets leads to long approval delays (of up to 3 to 5 years for one change worldwide) and is increasing the risk of shortages and hindering innovation.
Following the COVID-19 pandemic, several pilot projects using reliance for PACs have been initiated to increase the speed of regulatory actions, achieve global alignment and focus available resources on important public health matters. Some include company-specific unilateral reliance initiatives, many using EMA as reference agency. Additionally, initiatives by regulatory agencies, such as by South African Health Products Regulatory Authority (SAHPRA) and the Brazilian Health Regulatory Agency (ANVISA), have used reliance to reduce PAC backlogs. These early pilots demonstrate that using reliance for PACs is possible and can lead to successful outcomes with clear resource and time efficiency gains.
Reflecting on the experience gained during the various reliance pilots - how do we move from pilots to a routine practice where reliance becomes the standard practice globally for PACs approved by a reference agency (WLA)?
A DIA Europe 2025 Pre-Conference Workshop brought together regulators from different regions participating in DIA Europe 2025 and industry stakeholders to reflect on the practical experience when applying reliance approaches to PACs more widely. The discussion focused on learnings from recent unilateral reliance pathways using WLA (formerly stringent regulatory authorities) as reference agencies to speed up PAC approval timelines around the world. Continuous dialogue between industry and regulators and stronger collaboration between regulators discussing practical aspects of reliance-based real case examples is of particular importance to drive routine adoption of reliance for PAC, both for CMC, labelling/clinical updates and new indications.
The conclusions from this Workshop have been outlined in the Outcomes Report that can be downloaded below: