Middle East Clinical Trial Regulatory Update: Pioneering Frameworks

The Middle East Town Hall at DIA Europe 2024 showcased significant Middle East clinical trial regulatory advancements across the region, with representatives from Saudi Arabia, Egypt, Jordan, and Qatar detailing their strategies to enhance healthcare outcomes. Each country highlighted its unique approaches to aligning with international standards, leveraging reliance practices, and implementing digital solutions to streamline regulatory processes. These efforts underscore the region’s commitment to ensuring medical products’ safety, efficacy, and quality, ultimately improving patient access to essential treatments.

SFDA’s Strategic Vision and Regulatory Reforms: Aligning with Saudi Vision 2030

Bandar Al Hammad, Chief Pharmacist at the Saudi Food and Drug Authority (SFDA), detailed Saudi Arabia’s regulatory advancements aligned with the ambitious Saudi Vision 2030. This vision aims to diversify the economy and develop public services, including healthcare. SFDA has enhanced the regulatory framework to ensure medical products’ safety, efficacy, and quality. The strategy involves extensive benchmarking against global standards, including adopting guidelines from the International Council for Harmonisation (ICH). For example, by implementing ICH E6(R2) guidelines on Good Clinical Practice, the SFDA has reinforced Middle East clinical trial standards, ensuring ethical conduct and reliable data.

Bandar emphasized SFDA’s implementation of work-sharing and reliance practices, particularly within the Gulf Cooperation Council (GCC) regulatory network. This collaboration allows SFDA to leverage regulatory assessments from other member states, such as the rapid approval of products evaluated by the United Arab Emirates, expediting patient access to new treatments. SFDA’s milestones include streamlined drug approval procedures, enhanced pharmacovigilance systems, and continuous staff training. Collaborations with organizations like the WHO and PIC/S enable SFDA to adopt global best practices. Looking ahead, SFDA aims to integrate advanced data analytics and AI to enhance regulatory reviews, improving decision-making and risk mitigation. Through strategic vision, global benchmarking, and innovative practices, SFDA continues to advance healthcare outcomes in Saudi Arabia.

Transforming Drug Regulation in Egypt: EDA’s Journey Towards Sustainability

Hamada Sherief, Director of the General Administration of Registration of Pharmaceuticals at the Egyptian Drug Authority (EDA), detailed Egypt’s transformative journey towards sustainable drug regulation post-COVID-19. The pandemic highlighted the need for a flexible regulatory approach, prompting the EDA to enhance its frameworks for better responsiveness. A key innovation is the reliance model for market authorization and post-approval changes, allowing the EDA to use assessments from trusted international regulatory authorities like the US FDA or EMA to expedite approvals in Egypt. Additionally, the EDA streamlined post-approval changes, swiftly evaluating modifications in manufacturing processes, labeling updates, and new clinical data to maintain drug availability and compliance with safety standards.

The EDA has collaborated extensively with international regulatory bodies and industry stakeholders to support these initiatives, resulting in practical and effective guidelines. In April 2023, the EDA launched new guidelines for post-approval changes, incorporating feedback from over 50 industry meetings. This led to user-friendly, rigorous guidelines. The EDA also invested in digital solutions, creating a platform for pharmaceutical companies to submit variations electronically and streamlining the process. These efforts improved regulatory efficiency, with some product approvals taking as little as four months. Looking ahead, the EDA plans to enhance its reliance models and digital platforms further to keep Egypt at the forefront of regulatory innovation, ensuring timely access to high-quality medicines for patients.

JFDA’s Strategic Vision and Regulatory Reforms: Enhancing Healthcare in Jordan

Reem Al-Naimat, Head of Manufacturing Sites Accreditation Unit at the Jordan Food and Drug Administration (JFDA), outlined Jordan’s strategic vision to provide high-quality, affordable medicines while maintaining medical security. Central to this vision is achieving WHO maturity Level 3, indicating a robust regulatory system that ensures medical products’ safety, efficacy, and quality. To reach this goal, the JFDA implemented the WHO Global Benchmarking Tool (GBT), conducting a thorough self-assessment and formal evaluation by WHO experts. This review aligned JFDA’s practices with international standards, enhancing the credibility of Jordan’s regulatory system.

Reem emphasized the benefits of regulatory harmonization and work-sharing within the region. The JFDA participates in the Arab Regulators Network, promoting regulatory convergence and leveraging collective expertise. This collaboration enabled the JFDA to introduce accelerated registration procedures for essential medicines, vaccines, and treatments for chronic diseases, ensuring timely access to necessary treatments. The JFDA plans to strengthen its regulatory framework further through continuous collaboration with international bodies like the WHO and regional partners and by expanding digital technologies to streamline processes and improve transparency.

Advancing Regulatory Standards in Qatar: Cross-Referencing and Digitalization

Ahmed M Hussein Babiker, Head of the Drug Registration & Pricing Section at the Ministry of Public Health in Qatar, discussed the nation’s efforts to align with international regulatory standards through cross-referencing and reliance practices. By leveraging assessments from established authorities like the US FDA and EMA, Qatar expedites the approval process for new drugs, ensuring high safety, efficacy, and quality standards. During the COVID-19 pandemic, Qatar utilized reliance practices to quickly approve vaccines, relying on international evaluations to ensure timely public access. This approach was crucial for rapid response and effective public health protection.

Ahmed also emphasized the importance of digitalization in streamlining regulatory processes. The Ministry has developed an online platform for drug application submissions, tracking, and evaluations, significantly reducing approval times. This portal allows pharmaceutical companies to submit documentation, improving efficiency and transparency electronically. A key goal for Qatar is to achieve WHO maturity level recognition, which indicates a robust regulatory system. To support this, the Ministry has invested in extensive training and capacity-building programs for its staff. Plans include ongoing collaboration with international bodies like the WHO and regional partners, further enhancing Qatar’s regulatory framework and contributing to improved healthcare standards across the region.

Overcoming Challenges in Implementing Reliance and Post-Approval Changes

During the session, panelists discussed the challenges Middle East clinical trial regulatory bodies face in implementing reliance and post-approval changes. Discrepancies in documentation between regulatory authorities and pharmaceutical companies often arise due to varying requirements across jurisdictions. For example, a drug dossier approved by the European Medicines Agency (EMA) might not align with Middle East clinical trial standards, causing delays. To address these gaps, the Saudi Food and Drug Authority (SFDA) implemented a verification pathway to standardize documentation, while the Egyptian Drug Authority (EDA) developed digital tools to help companies comply with local requirements.

Another challenge is the need for continuous updates to regulatory guidelines to keep pace with scientific advancements and best practices. The Jordan Food and Drug Administration (JFDA) established a task force to regularly review and update its guidelines in collaboration with international experts. Harmonization efforts like the Arab Regulators Network facilitate the sharing of best practices and assessments among member countries. During the COVID-19 pandemic, this network enabled rapid information exchange, leading to quicker vaccine approvals. Future improvements include investing in digitalization, enhancing staff training, and strengthening international collaborations.

Summary

In conclusion, the collaborative efforts and innovative practices highlighted by the Saudi Arabia, Egypt, Jordan, and Qatar regulatory bodies are paving the way for improved healthcare outcomes across the Middle East. These countries are enhancing their regulatory frameworks by addressing challenges such as documentation discrepancies and the need for continuous guideline updates, as well as investing in digitalization and international collaborations. The progress in implementing reliance models, accelerated registration procedures, and robust digital platforms exemplify the region’s dedication to advancing regulatory standards, ensuring timely access to high-quality medicines, and ultimately fostering better health for their populations.