Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities
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View abstract on PubMed
Summary
This summary is machine-generated.A pilot project using regulatory reliance for post-approval changes (PACs) aims to speed up global drug approvals and ensure continuous medicine supply. This initiative streamlines the review process for critical manufacturing changes, benefiting patients worldwide.
Area Of Science
- Pharmaceutical manufacturing and regulatory affairs
- Global health policy and drug regulation
Background
- Post-approval changes (PACs) are essential for product lifecycle management but face lengthy global regulatory reviews, impacting medicine supply continuity.
- Reliance pathways, supported by the World Health Organization (WHO), are underutilized for PACs despite successes in initial marketing authorizations.
Purpose Of The Study
- To accelerate the review and approval of a supply-critical variation for a monoclonal antibody through a regulatory reliance pilot.
- To ensure continuous supply of critical medicines by targeting global approval within 6.5 months.
- To promote regulatory convergence and transparency among National Regulatory Authorities (NRAs) by leveraging European Medicines Agency (EMA) approval.
Main Methods
- A reliance pilot was established, utilizing the EMA's approval for a major chemistry, manufacturing, and control (CMC) change to a monoclonal antibody manufacturing process.
- A standardized variation package, identical to the EU submission, was provided to all participating NRAs.
- Engagement with the EMA, WHO, and 48 participating NRAs was conducted during planning and implementation phases.
Main Results
- The pilot successfully engaged 48 National Regulatory Authorities (NRAs) to join the reliance pathway for a critical medicine variation.
- The initiative aims for a streamlined global approval timeline of 6.5 months.
- The process promotes regulatory convergence by waiving country-specific requirements and enhances transparency through shared assessment reports.
Conclusions
- Regulatory reliance offers a viable strategy to expedite post-approval changes for critical medicines, ensuring supply continuity.
- Collaborative efforts between regulatory agencies and pharmaceutical companies can foster global regulatory convergence.
- The pilot demonstrates a successful model for leveraging established regulatory approvals to accelerate access to essential treatments worldwide.
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