Regulatory Reliance Workshop – March 20, 2025

Executive Summary

Introduction and Purpose

The Regulatory Reliance Workshop held on March 20, 2025, in Nairobi, Kenya, brought together experts from the Pharmaceuticals and Medical Devices sectors to discuss Regulatory Reliance, its implementation, benefits, and challenges in Kenya. Among the participants included members of KAPI, MEDAK, representatives from the Pharmaceutical Society of Kenya, Federation of Kenya Pharmaceutical Manufacturers, Pharmacy & Poisons Board, Egyptian Health Authority (EDA), MEDS with a mix of local, regional and international speakers and moderators drawn from local and international speakers. This workshop was a culmination of a process that began with an observation of mixed results on the use of regulatory reliance in Kenya at industry and health authority level. Among the observations being lack of clarity on practical application of reliance, skepticism on its value even among certain industry players, low level of satisfaction with reliance processes in general and low adoption despite the existence of guidelines supporting its use. To validate these concerns, a baseline survey was conducted between November 2024 and January 2025. This survey not only validated the concerns but also revealed a significant need for capacity building among both industry professionals and regulators regarding reliance practices. Therefore, the Regulatory Reliance Workshop was organized with the view of demystifying regulatory reliance, adding clarity, and providing an opportunity to create awareness about regulatory reliance among industry players and National Medicines Regulatory Authorities (NMRAs). Further, it sought to clarify reliance in practical terms.

Key Highlights and Presentations

John Mwangi of Bayer and KAPI opened the discussion by emphasizing the growing importance of reliance in modern regulatory frameworks, especially post-COVID-19. He introduced the necessity for regulatory reliance including highlighting the recent study by Lorrain et al on the economic value of regulatory reliance and advocated for a risk-based approaches to arriving at HA decisions. He argued that reliance is crucial for optimizing resources and improving regulatory oversight. He called for voluntary participation, a mindset shift, and incremental learning in implementing reliance. John outlined the WHO Good Reliance Practices and introduced the Africa Continental Regulatory Reliance Framework. He dispelled misconceptions about reliance – “what reliance is not”, clarifying it goes beyond timesaving and emphasized the need for working on enablers such as project and performance management and implementation of Information Management Systems tailored to support practice of reliance by NMRAs beyond new drug applications.

Ali Arale from Kenya’s Pharmacy and Poisons Board detailed the country’s reliance practices, legal framework, and collaborations with WHO and other international bodies, underscoring Kenya’s commitment to regulatory reliance. Rim Mahmoud from the Egyptian Drug Authority (EDA) presented EDA’s achievements, including reaching WHO Maturity Level 3, and discussed reliance pathways for marketing authorization and post-approval changes. Radwa Ahmed Saad El Gamil, also from EDA, highlighted the reliance approach for human pharmaceutical products, emphasizing the need for continuous improvement.

Arit Onwusah from Novartis discussed reliance practices in Ghana and Nigeria, emphasizing the need for engagement with regulators to address challenges and align with international standards. Rana Chalhoub from MECOMED highlighted the importance of Good Regulatory Practices (GRPs) and international cooperation, providing strategies for implementing reliance in the Middle East and Africa region. Angelika Joos discussed mitigating product shortages during Post-Approval Changes (PACs) through reliance practices, advocating for streamlined documentation and global harmonization. Francesca Mangia from F. Hoffmann-La Roche showcased a successful pilot project for a post-approval change that significantly reduced review timelines through reliance practices and demonstrated strong interest among National Regulatory Authorities (NRAs) while using cloud-based submission solution.

Outcomes and Benefits

We experienced an overwhelming response to the workshop, with over 150 participants joining online and more than 70 attending in person. Our collaboration with the Medical Technology Industry Association of Kenya (MEDAK) and the inclusion of representatives from local manufacturers added significant value to the event. The workshop content resonated deeply with attendees, sparking engaging discussions. A diverse lineup of local, regional, and international speakers effectively showcased the value of reliance across various contexts. Additionally, a pre-workshop survey guided our focus areas, ensuring that we addressed the most relevant topics. The presence of representatives from the Health Authority (HA) further facilitated valuable responses to audience questions that enriched the discussions.

The workshop yielded several significant outcomes and benefits. We secured a follow-up meeting with the Health Authority (HA) to address specific topics that may not have been fully covered during the workshop. In addition, the Health Authority in Kenya – Pharmacy and Poisons Board – announced a revised reliance guideline which was shared with stakeholders for comments until April 03, 2025. Resources permitting, we plan to use this workshop as a baseline for review next year and to design further interventions for both the HA and the industry as needed. Certain topics sparked further debate, including the concept of sameness, the differences between expedited and facilitated pathways, and their appropriate applications. Additionally, the workshop fostered transparency regarding how the National Medicines Regulatory Authorities’ (NMRA) Information Management System (IMS) should be designed and iterated to support effective reliance practices.

Recommendations & Call to Action

The following recommendations emerged from the workshop and the insights shared by different speakers and input from the audience;

Promote International Harmonization and Convergence: Encourage more regulatory harmonization and convergence by countries to align with international standards and practices as one means to facilitate the practice of regulatory reliance. This includes adopting WHO Good Reliance Practices and exploring bilateral and multilateral reliance agreements anchored on same regulatory standard.
Strengthen Capacity Building: Invest in training and development for National Regulatory Authorities (NRAs) and industry to enhance their understanding and implementation of reliance practices. This includes sharing best practices and leveraging partnerships.
Enhance Transparency and Data Sharing: Develop platforms and mechanisms for efficient data and information exchange among NRAs to support regulatory reliance decisions. This also includes implementing local infrastructure changes to allow smooth utilization of reliance pathways by applicants.
Apply a Risk-Based Approach: Implement risk categorization for products and activities to prioritize regulatory resources and streamline processes. This approach should be applied consistently across initial authorizations, post-approval changes, and other regulatory functions.
Ensure Product Sameness: Establish clear criteria and documentation requirements to verify the “sameness” of products under consideration for reliance to maintain quality, safety, and efficacy standards.
Expand Reliance Pathways: Explore and implement reliance for a broader range of regulatory activities, including post-approval changes, to increase efficiency and reduce duplication of efforts.
Foster Regulatory Cooperation and Trust: Build and maintain trust between NRAs through continuous dialogue, shared learning experiences, and collaborative projects. This includes engaging in joint assessments and work-sharing initiatives.
Address Legal and Regulatory Barriers: Identify and work towards removing legal, political, and regulatory obstacles that hinder the adoption and implementation of reliance practices. This includes addressing issues related to confidentiality, intellectual property, and varying regulatory requirements.
Leverage Technology and Digitalization: Utilize digital tools and platforms to facilitate the reliance process, including electronic submissions, digital labels, and online platforms for regulatory interactions.
Engage with Stakeholders: Involve industry, healthcare professionals, and patients in discussions on reliance to ensure that the regulatory processes remain transparent, inclusive, and responsive to stakeholders’ needs. This includes involving these stakeholders in the development of reliance guidelines.