Regulatory Harmonization and Streamlining of Clinical Trial Applications globally should lead to faster clinical development and earlier access to life-saving vaccines. Issue 5 (29th January 2021)

• Record Type: Journal Article
• Authors: Scheppler, Lorenz; De Clercq, Norbert; McGoldrick, Mic; Dias, Jacqueline
• Is Part Of: Vaccine. Volume 39:Issue 5(2021)
• Page Start: 790
• Page End: 796
• Publication Date: 2021-01-29
• Subjects: Clinical trial application -- Regulatory convergence -- Development -- Streamline -- Vaccine; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2020.11.077
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Vaccines continue to play a central role in our ability to prevent disease, save lives, and improve health. The scientific community, including our own researchers, are driven by a shared purpose to improve vaccine technologies and bring the benefits of immunization to everyone, regardless of where they live – as soon as possible, especially when the medical need is considerable. Vaccine developers and manufacturers (sometimes referred to as "study sponsors" or "applicants") are exploring technological advancements to translate breakthrough discoveries into novel vaccines which have the potential to provide protection from life-threatening and debilitating infectious diseases. Developing new vaccines is a lengthy process regulated by guidance provided by independent organizations, National Regulatory Authorities (NRAs) and the World Health Organization. As most infectious diseases can span a considerable area of the world, clinical trials are often conducted across different countries and regions. Regulatory requirements for clinical trials (both Chemistry Manufacturing & Controls – CMC, nonclinical and clinical) vary significantly between the different countries and regions adding to the complexity of vaccine development and leading to significant delays in the development of novel vaccines and ultimately equitable access for populations to these innovations. Without progress in terms of regulatory convergence and harmonization the benefits from these scientific advancements will not be fully realized. There is an urgent need by global bodies such as WHO to partner with and the NRAs to establish and implement. 1. a common, global set of requirements for Clinical Trial Application (CTAs) per Phase of Development. 2. a parallel ethical committee and regulatory authority review rather than sequential reviews. 3. clear and transparent assessment timelines and commitment to these timelines. 4. a focus on reduced regulatory burden overall for NRAs, Ethics Committees (ECs) and vaccine developers.