Overview 

A streamlined regulatory submission process was developed using COVID-19 as a baseline, drawing on lessons learned from the global response to create a scalable framework. The primary objective of the process is to guide the rapid regulatory decision of Emergency Use Listing or Authorization or Marketing Authorization as an outcome. The process identifies a new, first-of-its-kind Industry Collaborative Cloud-Based Ecosystem to be utilized, providing global visibility and real-time information sharing across regulatory authorities — something that was not possible during previous crises. This new model will improve the way regulators and life sciences organizations interact, allowing for secure communication on an international scale. 

Proposed Process 

The proposed process facilitates the creation and submission of a single, unified dossier to multiple regulators simultaneously via a cloud-based platform (Accumulus Synergy), helping to streamline the review process and reduce the redundancy of submitting the same information multiple times. The process is designed to guide where each developer can create and implement a strategy for sharing regulatory information with national regulators simultaneously. Regulators can review all, some or none of the documentation submitted, based on their capacity and whether or not they would like to use a reliance process to expedite approvals.  

While the process is designed for a global response, it accommodates individual country decisions and regulatory requirements, recognizing the importance of local context in emergency responses. The process also includes post-authorization activities, such as amendments to address requirements that were waived by regulatory authorities at the time of the initial filing. Additionally, it includes commitments for transitioning to permanent authorization, ensuring ongoing compliance and long-term regulatory approval. 

The process includes the following elements:

1. Develop Global Submission Strategy 

2. Data Generation 

3. Content Authoring 

4. Dossier Compilation 

5. Submit Dossier 

6. NRA Review 

7. NRA Decision 

8. Dossier Archiving 

The process is illustrated in Figure 1.

Figure 1: Proposed, Streamlined, Regulatory Submission Process

Flexibility and Adaptation 

The process emphasizes the need for flexibility and the ability to adapt quickly as public health emergencies (PHE) evolve and new information becomes available. This means that the process should not be rigid but should allow for adjustments and modifications in response to changing circumstances. Some steps in the process may need to be done in parallel rather than sequentially to expedite the overall timeline. For example, data generation and content authoring might occur simultaneously to save time, rather than waiting for one to be completed before starting the other. This approach ensures that the process remains dynamic and responsive to the fast-paced nature of public health emergencies. 

Collaboration and Coordination 

Enhanced real-time collaboration between developers and international regulatory bodies is crucial for harmonizing efforts and sharing critical data. This involves creating a collaborative environment where stakeholders can communicate and coordinate effectively. The use of a cloud-based platform facilitates this by providing a centralized space for information exchange and joint decision-making. By working together in real-time, developers and regulators can address issues more efficiently, share insights, and ensure that regulatory reviews are conducted in a harmonized manner. This collaborative approach helps to avoid duplication of efforts and ensures that all parties are aligned in their response to the emergency. 

Resource Allocation 

Ensuring adequate resources are allocated to handle the increased workload and urgency of the situation is essential for the success of the proposed process. This includes not only financial resources but also human resources, technology, and infrastructure. Organizations must be prepared to mobilize additional staff, invest in necessary technology, and allocate funds to support the emergency response. Proper resource allocation ensures that all aspects of the process, from data generation to regulatory review, are adequately supported and can be carried out efficiently. It also helps to prevent bottlenecks and delays that could hinder the overall response effort. 

Technology Compatibility 

Identifying and integrating necessary systems to support the emergency process is a key consideration. This involves ensuring that the technology used is compatible with the requirements of the process and can handle the inputs and outputs efficiently. For example, the cloud-based platform used for dossier submission must be able to integrate with the systems used by national regulatory authorities (NRAs) and other stakeholders. Clear definitions of input and output requirements are essential to ensure that data is transferred seamlessly and that all parties can access the information they need. Technology compatibility also includes ensuring that the systems are secure and can protect sensitive information from unauthorized access. 

Content Development and Information Exchange 

Establishing clear protocols for content development and information exchange is critical to ensure accurate and timely dissemination of critical information. This involves setting guidelines for how data should be generated, documented, and shared among stakeholders. Clear protocols help to standardize the content and ensure that it meets the requirements of regulatory authorities. They also facilitate efficient information exchange by providing a framework for how information should be communicated and shared. This ensures that all parties have access to the necessary information in a timely manner, which is crucial for making informed decisions during a public health emergency. 

Conclusion 

The proposed process aims to create a more efficient and collaborative approach to managing public health emergencies. By leveraging a cloud-based platform for real-time information sharing and unified dossier submissions, the process seeks to streamline regulatory reviews and expedite emergency use authorizations. The process also emphasizes the importance of flexibility, collaboration, resource allocation, technology compatibility, and clear protocols for content development and information exchange. Ultimately, the goal is to improve global response efforts and ensure ongoing compliance and long-term regulatory approval.