RT Journal Article
SR Electronic
T1 Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 388
OP 398
DO 10.5731/pdajpst.2023.012850
VO 78
IS 4
A1 Gastineau, Thierry
A1 Ban, Cynthia
A1 Basso, Ana
A1 Brehme, Franziska
A1 Silva, Ana Luisa
A1 Faure, Olivier
A1 Palaire, Lyne Le
A1 Persaud, Priya
A1 Rodriguez, Heraclio
YR 2024
UL http://journal.pda.org/content/78/4/388.abstract
AB When an initial marketing authorization of a pharmaceutical product is granted, a substantial number of chemistry, manufacturing, and control (CMC) post approval changes (PACs) have to be managed by the manufacturers. Despite efforts undertaken over the years by multiple regulatory jurisdictions, there is still heterogeneity in terms of regulatory requirements and timelines across national regulatory authorities (NRAs). This creates complexity in managing global CMC PACs, putting the supply of medical products at risk. Regulators have developed regulatory mechanisms that aim at accelerating the reviews and approvals of PACs by NRAs. The World Health Organization (WHO) is supporting the concept of “reliance” among NRAs, which are encouraged to rely on the assessment completed by a “highly performing authority”. The objective is to accelerate the overall process for PACs, ultimately fostering more equitable and timely access to medical products for populations who need them. With the support of Health Canada, WHO, Pan American Health Organization, and the Paul-Ehrlich-Institut, Sanofi has launched a pilot using the principles of reliance for a CMC PAC for a vaccine, with 21 NRAs who accepted to participate in the pilot. The objective of this pilot was to apply these principles to reduce the approval timeline to a maximum of 6 months in all countries after an initial approval is granted by a reference authority. We discuss the opportunities and challenges of implementing reliance principles for CMC PACs. We also describe the pilot experience by sharing initial lessons learned from the Step 1 of this pilot, which consisted of engaging the reference authority and the NRAs.