The healthcare industry is continually transformed by the rapid evolution of science and medicine. Technology has been a key driver, enabling advancements like real-world evidence, personalized medicine, and data analytics that can accelerate the development of life-saving therapies. However, bringing new medicines to patients around the world and ensuring a consistent global supply can be a complex and lengthy process. Timely approval of marketing authorization applications and post approval variations is critical for patient access, and for maintaining supply continuity. Both the pharmaceutical industry and regulatory authorities can work together to streamline these processes, promoting more timely access to new and improved medicines for patients.

The World Health Organization (WHO) actively promotes the use of informed reliance as a twenty-first-century regulatory solution. This method leverages the work of trusted partners, such as advanced regulatory authorities or the WHO Prequalification program, to expedite product approval, particularly in low- and middle-income countries (LMICs). National Regulatory Agencies (NRAs) can rely on assessments performed by a reference regulatory authority (e.g., a WHO Listed Authority) to streamline their review and authorization processes while retaining the autonomy to make their own regulatory decisions. Encouraging the practice of evidence-based reliance builds efficiencies for both health agencies and the pharmaceutical industry.

Submitting a single application facilitates collaborative reviews among NRAs, creating opportunities for collaborative assessments, full or partial reliance that can increase efficiency. By implementing risk-based approaches while ensuring scientific rigor, we can accelerate product development and maintain patient access to essential medicines. The use of cloud-based platforms could enable the streamlined preparation, management, and sharing of standardized regulatory documentation to NRAs.

Several existing programs and pilot projects that use work-sharing models or unilateral reliance based on reference agency assessment are ongoing. A successful work-sharing program can promote global alignment and improve regulatory efficiency by eliminating redundancies, allowing both regulators and industry to use their resources more effectively. The results so far demonstrate that these reliance pathways have great potential to increase efficiency and could be integrated into standard operations where appropriate.

This plenary session will explore how different reliance and collaborative pathways can expedite patient access to medicines. We will delve into how industry and regulators can work together to make this a common global practice, leveraging cloud-based platforms to enhance collaboration and build trust.

Session Speakers:

Insights to Industry Led CMC PAC Reliance Pilots on behalf of EFPIA
Cynthia Ban, Sanofi Pasteur Limited Canada

International Collaboration and Reliance
Brian Dooley, EMA-European Medicines Agency

Pivoting to Platform: A Case Study in Leveraging Reliance to Enable Fast Implementation of Platform Method for Commercial Products

Christine Wu, Genentech, a Member of the Roche Group

Leveraging Reliance for Accelerating Global Access to Vaccines: A GSK Case Study
Katharine Duncan, GlaxoSmithKline

Additional Panelists:

Robin Levis, CBER, FDA
Claudia Müller, Swissmedic

Dean Smith, Health Canada

Dulce Aldana Sanchez

Appearances