Around the Globe
Middle East Regulatory Landscape:
Collaboration, Agility, and Adaptation
Amira Younes
AbbVie, UAE

he COVID-19 pandemic highlighted the need for new ways of thinking about delivering regulatory effectiveness and efficiency, and for flexibility from all stakeholders to ensure that therapies continued to reach patients in a timely manner.

Most countries in the Middle East already had priority or expedited pathways prior to the pandemic. These pathways delivered shorter assessment timelines and demonstrated the usefulness of regulatory reliance during the global emergency. Jordan, Saudi Arabia, Bahrain, and Egypt created guidelines for Emergency Use Authorizations (EUA) for vaccine or therapeutic product use, as well.

The Egyptian Drug Authority (EDA) recognized WHO prequalified products listed under the WHO Emergency Use Listing Procedure (EUL) or approved by reference agencies, which allowed for faster batch release through minimum document review and minimum testing. Other countries including Qatar set aside normal submission practices, enabled rolling submissions of dossiers, and waived country-specific Module 1 requirements. These flexibilities in regulatory frameworks prepare healthcare systems for future pandemics and can allow faster patient access to medications in noncrisis circumstances.

Agility and adaptation also proved to be key components in the sustained success of regulatory systems in the region. Streamlined decision-making frameworks and procedures helped prioritize regulatory actions among health authorities and allowed for knowledge exchange and continuous improvement.

The pandemic also accelerated digitalization in the Middle East. Some countries moved toward digitalization and introduced online submission systems during the pandemic. Others already had existing digital platforms and were using the electronic Common Technical Document (eCTD) for submissions (e.g., Oman, Bahrain, Qatar, Jordan, United Arab Emirates [UAE], and Saudi Arabia), reducing the need for physical documentation while accelerating registration and access. Most regulators adapted their national procedures to allow use of electronic Certificates of Pharmaceutical Products (e-CPPs).

Some countries (for example, Lebanon and Egypt) officially eliminated the physical legalization requirement for authentication purposes from their guidelines, encouraging use of the validation tool/system by the e-CPP issuing authority for authentication, and enabling review and access continuity with the European Medicines Agency (EMA) and US FDA validation systems.

Trends Enabling Reliance and Trust

Collaboration, convergence, harmonization, and similar best practices have been at the center of discussions related to the Middle East regulatory environment. These are the basis to enable reliance and trust and proved during the pandemic that they will provide the way forward for medical products registration as key enablers to managing the challenges of resource constraints, capability building, and removing barriers to patient access to medicines.

Many Middle East health authorities have already adopted reliance procedures and increasingly lean on networking, dialogue, and trust while maintaining their sovereignty and autonomy in decision making, strengthening regulatory system capacity in the region. This Reliance model was initiated in the Middle East region by the Saudi FDA and was later adopted by health authorities in Egypt, Jordan, Kuwait, and the United Arab Emirates (UAE).

WHO defines Good Reliance Practices: The act whereby the regulatory authority in one jurisdiction takes into account and gives significant weight to assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. The relying authority remains independent, responsible, and accountable for the decisions taken, even when it relies on the decisions, assessments, and information of others.

In addition to using reliance in initial marketing authorizations, the region is advancing toward expanding the use of reliance for post-approval changes. For example, guidelines from the Jordan Food and Drug Authority (JFDA) extend its reliance procedures to post-approval changes that are supported by EMA and/or US FDA approvals.

In April, the World Health Organization (WHO) published two documents that are critical for countries working to strengthen their regulatory systems through regulatory cooperation, convergence, and transparency: Good Regulatory Practices (GRP) and Good Reliance Practices (GReP), published as Annexes 10 and 11 in the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), support improving country oversight and regulation of medicines and other healthcare products and promoting greater regional and international collaboration to leverage resources more efficiently and ensure that quality health products reach people faster.

WHO also established and implemented a framework for evaluating and publicly designating regulatory authorities as WHO Listed Authorities (WLA). National Regulatory Authorities from the Middle East region are assessed through this process to determine their maturity levels. The EDA, for example, has made great progress in building its regulatory capacity and implementing GRP and GReP principles into its processes. As a result, EDA has achieved WHO classification of maturity level 3 for (locally produced and imported) vaccines regulation.

The region has also made great progress toward regulatory convergence, the acceptance and implementation of internationally recognized technical guidance documents and regulatory mechanisms. Participation in international forums like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA) supports convergence on standards and regulatory requirements while building trust and mutual collaboration among health authorities. Some countries in the Middle East region are ICH observers; for example, the JFDA, Lebanon Ministry of Public Health (MOPH), and Iran Ministry of Health (MOH). The EDA was announced as an ICH observer at the ICH assembly meeting in November 2021, and the Saudi Food and Drug Administration (SFDA) was announced as an ICH member at the ICH assembly meeting in June 2021. SFDA and EDA are also ICMRA associate members.

Electronic Labeling (eLabeling)

Patients, healthcare providers, regulators, and industry are already experiencing the benefits of eLabeling, which ensures that necessary information is accessible to all stakeholders in a timely manner and allows for better post-market surveillance. eLabeling has been active in several jurisdictions, including Saudi Arabia, Egypt, the United Arab Emirates (UAE), the Gulf Health Council (GHC), and most recently Bahrain. Implementation of this digital solution is moving rapidly, with several companies launching pilot projects aimed at supporting and advancing these regulatory activities, better understanding necessary local adaptations, and preparing other stakeholders for transitioning from paper to electronic labeling. This new digital reality will enable faster access to updated product labeling information.

Other Innovations

The region is maturing in other aspects of its approach to the approval of innovative medications and registration of orphan drugs and advanced therapies to treat rare diseases. It is encouraging to see the Saudi FDA issue a draft guideline for orphan drug designation and discuss using real-world data (RWD) to support regulatory decision making.

The Middle East region is rapidly evolving, learning from the challenges posed by the COVID-19 pandemic, with the implementation of various regulatory tools such as the ones described above. Collaboration, agility, and adaptation to new processes and innovation are the way forward to providing a strong foundation to the region’s future regulatory preparedness.

Disclaimer: The author is currently a full-time employee of AbbVie Inc. Opinions expressed herein are the author’s and do not reflect the opinion of AbbVie Inc.