Bringing new medicinal products to patients worldwide and ensuring uninterrupted supply of high-quality medicines can involve complex and lengthy processes. Timely approval of marketing authorization applications is critical for facilitating access of patients to new medicinal products, including innovative therapies for many rare diseases. Additionally, timely approval of variations is critical for ensuring continuity of the supply of quality medicinal products in the global market. Both industry and regulatory authorities both can play a role in increasing efficiencies that would promote more timely access for patients to new and improved medicinal products.

Submission of the same application can facilitate collaborative review among National Regulatory Agencies (NRAs) and opportunities for full or partial reliance to increase efficiency. Implementation of risk-based approaches while ensuring scientific rigor can speed product development and promote continuity of patient access to essential medicines. The World Health Organization (WHO) strongly encourages the use of informed reliance as a 21st century regulatory solution to leverage the work of trusted partners (e.g., more advanced regulatory authorities, WHO PQ program) to facilitate product approval, especially in low-and-middle-income countries (LMICs). NRAs can rely on assessments performed by a reference regulatory authority (e.g., a WHO Listed Authority) to streamline the review and authorization process while maintaining national autonomy to make regulatory decisions. Promoting the practice of evidence-based reliance can build efficiencies for both health agencies and industry.

Several existing programs and pilot projects that use work-sharing models or unilateral reliance based on reference agency assessment are ongoing. A well-designed program for work-sharing and reliance can promote global alignment, increase regulatory efficiencies, and allow regulators and industry to utilize resources more effectively by eliminating redundancies. The experiences to date demonstrate that ‘reliance pathways’ hold the potential to increase efficiencies and could be considered, where appropriate, for mainstream operation.

This Plenary Session aims to understand opportunities and challenges of utilizing ‘Reliance’ as a mechanism to facilitate regulatory decision-making and explore practical aspects of how industry and regulators can help this to become a common practice globally. Evidence-based reliance can be one tool in ‘smart’ regulation which could enhance regulatory efficiencies and bring quality medicines to patients in a timely manner.

Session Speaker:

Ignite the Future - Our Exciting PAC Reliance Journey With 48 NRAs

John Armando, Genentech, a Member of the Roche Group

Rogério Gaspar, World Health Organization

Additional Panelists:

José Crisóstomo Landeros, Instituto de Salud Pública de Chile

Anabela Marçal, EMA-European Medicines Agency

Lawrence Starke, Novartis Pharmaceuticals Corporation

Susanne Ausborn

Appearances