Pandemic Preparedness and Response, Vaccine Development Ecosystem Strengthening and Use of Innovative Regulatory Approaches when Efficacy Studies are not Feasible
The Asia-Pacific Regional Summit (10–12 March 2026, New Delhi, India) convened scientific leaders, regulators, ministries of health, manufacturers, researchers, technical experts and global partners to strengthen pandemic preparedness and response through (1) an end-to-end vaccine development ecosystem approach and (2) innovative regulatory approaches when traditional efficacy studies are not feasible. The program combined plenary and technical sessions, interactive breakouts, and disease-focused case studies (chikungunya, Nipah, and Kyasanur Forest disease (KFD)) to translate recent lessons—particularly from COVID 19—into practical actions for the region.
The Next Public Health Emergency
Workshop Recommendations on How Regulatory Agencies and Vaccine Developers Across the World Can Be Better Prepared
This article summarizes the work (including a series of workshops) the CEPI Regulatory and Quality Team has been doing to support the use of platform technologies, the Accumulus cloud-based information sharing tool, and other regulatory innovations across the Global South.
How to accelerate the supply of vaccines to all populations worldwide?
This article reflects on lessons from the COVID-19 pandemic to accelerate global vaccine access, emphasizing regulatory agility, collaboration, and risk-based approaches. It compares challenges faced by early and later vaccine manufacturers, highlighting successes like reliance on trusted regulatory approvals, digital solutions, and streamlined processes. Post-pandemic shifts to rigid requirements, however, risked supply chain delays. The paper advocates sustaining flexible frameworks, harmonized standards, and global cooperation to ensure rapid response in future crises. Ideal for public health professionals, regulators, and industry stakeholders seeking insights into optimizing vaccine development and distribution.
A roadmap for fostering timely regulatory and ethics approvals of international clinical trials in support of efficient global health research
A panel of international experts in clinical research proposes key actions to improve coordination and streamlining of regulatory and ethics review. Streamlining and harmonising review processes, while ensuring rigorous scientific standards, proper safety, and ethical oversight, is crucial for efficient, robust, and timely multinational trials. AVAREF joint regulatory and ethics reviews are highlighted as an outstanding example. Robust regulatory and ethics review systems thrive on continuous learning and efficient processes, crucial for high-quality research.
Advancing local manufacturing capacities for vaccines within Africa – Opportunities, priorities and challenges
CEPI collaborated with ACDC and UCL to author this paper on advancing local manufacturing capacities and defining priority vaccines for Africa. It emphasizes the importance of preferential procurement and adequate regulatory systems, and it serves as a blueprint for policymakers, researchers, and manufacturers to enhance vaccine production capabilities. By focusing on regional priorities, this review aims to catalyst discussions and initiatives that will bridge significant gaps in vaccine accessibility across the African continent.
Expanding Master Files for human medicinal products in the EU/EEA
CEPI and EFPIA collaborated to author a regulatory position paper on master files in the EU. A new “Pharmaceutical Master File” overarching model is proposed that encompasses existing master files procedures as well as expanded approaches not in place today. The flexible and modular Pharmaceutical Master File aims at enabling faster access to novel medicines, including vaccines.
