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Reliance for Post-Approval Changes: 

How do we move from exceptional to routine use?

Summary Report from the DIA Europe 2024 Pre-Conference Workshop


Simultaneously to patients waiting for supply of licensed medicines and vaccines, the regulatory workload necessary to maintain the authorised products is increasing.

To cope with this demand, regulators are implementing reliance models for different regulatory activities, such as initial applications, new indications, inspections, post-approval changes and pharmacovigilance. Adoption of global standards, appropriate regulatory processes and frameworks that allow sharing of confidential information are key enablers for fostering agency collaboration across countries and regions. Solidarity and trust are necessary to establish more collaboration between regulators and contribute to regional and/or global convergence.


Whilst reliance approaches are increasingly being used for New Authorisation Applications (MAAs), their use with Post-Approval Changes (PACs) is limited, despite these activities comprising the bulk of regulatory work. These 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 processes, 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), 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 speed of regulatory action, achieve global alignment and focus available resources on important public health matters. These include the ICMRA collaborative pilot and company-specific initiatives, such as the Sanofi pilot and the Roche pilot. Initiatives by regulatory authorities, such as the South African Health Products Regulatory Authority (SAHPRA) and the Brazilian Health Regulatory Agency (ANVISA), have used reliance to reduce backlogs including for PACs. These early pilots demonstrate that using reliance for PACs is possible and can lead to successful outcomes. The use of reliance now needs to be broadened, which could help to reduce PAC timelines and contribute to reducing supply risk of medicinal products.

The key question is - how do we move from isolated Reliance pilots to a routine practice of Reliance for Post-Approval Changes, globally?

In March 2024, a pre-conference workshop brought together global regulators from different regions participating in DIA Europe 2024 and industry stakeholders to discuss the practical aspects of applying reliance approaches to PACs more widely. This pre-conference workshop aimed at building on the findings of a similar workshop that happened the year prior, before DIA Europe 2023, which explored collaboration and convergence of country specific requirements towards global standards. The main conclusions from the first workshop can be thoroughly explored in its outcomes report and are summarised below:

  • Differences exist in information requested to enable reliance (e.g., assessment reports, Q&A documents, approval letters, Certificates of Pharmaceutical Product [CPP], etc.).
  • Continuous dialogue is key to optimise existing pathways or establish new reliance guidelines.
  • Industry and regulators are generally aligned on characteristics needed to support product sameness; acceptance of differences is a case-by-case approach based on justification.
  • Many regulatory authorities still have country-specific requirements going beyond international standards (ICH/WHO), including purely administrative ones, that are not necessarily justified from the point of view of modern international regulatory science.
  • Convergence and harmonisation of CTD Modules 1 and 3 are identified as an area of immediate focus.

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Reliance for Post-Approval Changes: 

How do we move from exceptional to routine use?

Summary Report from the DIA Europe 2024 Pre-Conference Workshop


Simultaneously to patients waiting for supply of licensed medicines and vaccines, the regulatory workload necessary to maintain the authorised products is increasing.

To cope with this demand, regulators are implementing reliance models for different regulatory activities, such as initial applications, new indications, inspections, post-approval changes and pharmacovigilance. Adoption of global standards, appropriate regulatory processes and frameworks that allow sharing of confidential information are key enablers for fostering agency collaboration across countries and regions. Solidarity and trust are necessary to establish more collaboration between regulators and contribute to regional and/or global convergence.


Whilst reliance approaches are increasingly being used for New Authorisation Applications (MAAs), their use with Post-Approval Changes (PACs) is limited, despite these activities comprising the bulk of regulatory work. These 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 processes, 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), 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 speed of regulatory action, achieve global alignment and focus available resources on important public health matters. These include the ICMRA collaborative pilot and company-specific initiatives, such as the Sanofi pilot and the Roche pilot. Initiatives by regulatory authorities, such as the South African Health Products Regulatory Authority (SAHPRA) and the Brazilian Health Regulatory Agency (ANVISA), have used reliance to reduce backlogs including for PACs. These early pilots demonstrate that using reliance for PACs is possible and can lead to successful outcomes. The use of reliance now needs to be broadened, which could help to reduce PAC timelines and contribute to reducing supply risk of medicinal products.

The key question is - how do we move from isolated Reliance pilots to a routine practice of Reliance for Post-Approval Changes, globally?

In March 2024, a pre-conference workshop brought together global regulators from different regions participating in DIA Europe 2024 and industry stakeholders to discuss the practical aspects of applying reliance approaches to PACs more widely. This pre-conference workshop aimed at building on the findings of a similar workshop that happened the year prior, before DIA Europe 2023, which explored collaboration and convergence of country specific requirements towards global standards. The main conclusions from the first workshop can be thoroughly explored in its outcomes report and are summarised below:

  • Differences exist in information requested to enable reliance (e.g., assessment reports, Q&A documents, approval letters, Certificates of Pharmaceutical Product [CPP], etc.).
  • Continuous dialogue is key to optimise existing pathways or establish new reliance guidelines.
  • Industry and regulators are generally aligned on characteristics needed to support product sameness; acceptance of differences is a case-by-case approach based on justification.
  • Many regulatory authorities still have country-specific requirements going beyond international standards (ICH/WHO), including purely administrative ones, that are not necessarily justified from the point of view of modern international regulatory science.
  • Convergence and harmonisation of CTD Modules 1 and 3 are identified as an area of immediate focus.

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