Middle Eastern pharmaceutical companies are increasingly prioritizing innovation, amid significant regulatory reforms and harmonization efforts. The region encompassing a diverse range of countries, presents both challenges and opportunities for companies aiming to enter these markets.
In this Blog, we explore the key elements of the evolving regulatory frameworks in middle east.
Fragmented and complex regulatory landscape in Middle East
The regulatory environment in the Middle East is marked by fragmentation Each independent nation has their regulatory authorities with its own set of technical and administration requirements for drug registration. Such lack of standardization has been a roadblock to the drug approval and commercialization process.
For example, stringent local requirements and lengthy approval processes have historically made it difficult for companies to bring new products to market. But in the past several years, there’s been an emphasis to stabilize those processes, particularly under reliance programs that rely upon approvals from well-known agencies like the EMA and US FDA. Fast-track procedures have also been enacted in Saudi Arabia, Jordan, and Egypt for drugs that have already been approved by the agencies, which has reduced the time to get approval.
Harmonisation and Collaborative Initiatives:
A key initiative in the region has been the move toward harmonized regulation. For example, the Gulf Cooperation Council (GCC) has implemented a unified drug pricing strategy and established a centralized registration system through its Central Gulf Committee for Drug Regulation—which comprises Bahrain, Oman, Saudi Arabia, Kuwait, the United Arab Emirates, and Qatar. This initiative aims to ensure that drugs meet international quality standards while facilitating market entry for foreign companies These initiatives are part of a broader drive toward regulatory harmonisation in collaboration with international bodies such as ICH and WHO.
Country-specific reforms:
UAE: With the introduction of new federal decree law no. 38 of 2024, the UAE is leading the way in regional innovation. This new law unifies the various separate pharmaceutical regulations at the federal level while introducing initiatives on security in the supply chain, drug approval process, and foreign investment. Emerging areas such as biobanks and genetically modified organisms for medical uses will be regulated, part of an effort by the UAE to establish itself as a regional and global leader in pharma innovation.
Saudi Arabia: In alignment with Vision 2030, the SFDA aims to ensure the safety, efficacy, and quality of medical products. They benchmark against global standards like ICH E6(R2) for Good Clinical Practice and leverage reliance practices within the GCC regulatory network to expedite approvals. They also aim to integrate data analytics and AI to enhance regulatory reviews.
Egypt: The EDA (Egyptian Drug Authority) is leading the way in drug regulation, adopting flexibility in their approach during the post-COVID-19 era. An important innovation is the reliance model for market authorization, whereby these assessments from trusted international authorities like the US FDA or EMA allow for expedited approvals. The EDA also simplified the drug approval process through recognition of WHO Prequalified products and simplified reliance practices. Such measures greatly reduce the documentation and testing timelines.
Jordan: Jordan is committed to ensuring the supply of affordable, high-quality medicines while aiming to achieve WHO Maturity Level 3. They utilize the WHO Global Benchmarking Tool (GBT) for the alignment of practices with international standards and are involved in the Arab Regulators Network for regulatory harmonization, enabling fast-tracking of registration procedures for essential medicines.
Qatar: Qatar uses cross-referencing and reliance practices to align with international regulatory standards, applying assessments from agencies such as the US FDA and EMA to speed up drug approvals. They also focus on digitalization, having built a digital platform for submissions of drug applications and evaluations. Qatar’s primary objective is to achieve WHO Maturity Level recognition for its regulatory system.
Challenges facing the region
The pharmaceutical regulatory landscape of middle east faces several obstacles that impede its progress and development. One major challenge lies with the fragmented regulatory environment, creating complex drug registration and approval processes that makes it difficult for pharmaceutical companies from entering the market. Additionally, quality and safety concerns persist due to the prevalence of counterfeit drugs and inadequate pharmacovigilance systems that pose substantial risks to patient health. Efforts to harmonize regulatory requirements remain insufficient, as discrepancies between local standards and international guidelines such as those issued by EMA and FDA continue to inhibit expedited approvals. Economic pressures like price controls can limit innovation and investment by restricting profit margins of pharmaceutical companies. Furthermore, the region’s heavy reliance on imported pharmaceuticals makes it vulnerable to price fluctuations and potential shortages. Addressing these challenges requires coordinated efforts to improve regulatory harmonization, enhance local manufacturing capabilities, and strengthen oversight mechanisms.
Conclusion
Positive steps are being taken in the Middle East towards a more cohesive and effective regulatory framework. By adopting digital practices, encouraging regional collaboration, and matching global standards, the region can be a hub for pharmaceutical advancement.
For companies looking to enter this marketplace, understanding each of the countries’ regulatory framework is critical. The other regions explored reforms and harmonisation, and the Middle East holds great promise; however, while it will be an exciting region to monitor over the coming decade, it does undoubtedly have considerable room for growth in pharmaceuticals.
As part of its pharmaceutical product portfolio, DDReg provides regulatory solutions for generics, biosimilars, and medical devices along with the entire product lifecycle. With experience of over 120 regulatory agencies and subject matter expertise, DDReg is the go-to-partner for pharmaceutical regulatory services. Read more from the experts: Comparing PRIME and EU Pathways: Long -Term Strategy and Global Impact