edicines continue to evolve long after their initial approval through changes in manufacturing, packaging, labeling, and safety information, thereby making robust lifecycle management (LCM) essential to maintain quality, safety, and efficacy.

While many global health authorities are embracing regulatory convergence and reliance to optimize post-approval changes (PACs), the regulatory landscape in the Middle East and North Africa (MENA) region is complex and heterogeneous in nature. In some cases, rigid systems lead to delayed implementation of changes, supply disruptions, and regulatory inefficiencies.

A benchmarking survey designed and conducted by the EFPIA Middle East Regulatory Network (MERN) and IFPMA Africa Regulatory Network (ARN) collected data from 14 MENA countries and uncovered both encouraging trends and significant gaps in LCM regulatory systems. These findings present an opportunity to build on positive momentum and advocate for structured modernization across the region.

Get the Facts Straight

The benchmarking survey, conducted from June to September 2024, provided a snapshot of PAC management systems across 14 MENA countries: Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, UAE, Algeria, Libya, Morocco, and Tunisia. Key themes emerged:

• Risk-based PAC reporting categories exist in 11 countries, but most of them are not fully aligned with European Medicines Agency (EMA) or World Health Organization (WHO) guidelines. Only five countries have a “Do-and-Tell” (implemented without prior approval) reporting category for minor changes; the rest need either prior approval or notification before implementation.
• Reliance has not been used for the assessment of PACs in most countries, with only two countries adopting a reliance pathway in their local variation guidelines. Reliance is used more often in on-site inspection, with 13 countries applying reliance to inspection when registering a new manufacturing site. In addition, two countries adopt a reliance-based exemption for local testing if the variation is approved by reference NRAs (National Regulatory Authorities).
• The approval timeline for PACs is very diverse and unpredictable in the MENA region. Only five countries define an approval timeline for PACs in the local guideline, and the practical approval timelines among 14 countries vary widely from 0 to 36 months for major changes, making it difficult to plan global launches or ensure synchronized implementations.
• Limitations on submission appointments are one of the challenges in the MENA region. Companies must make appointments to schedule their submissions because NRAs can accept only a limited number of applications within a certain timeframe. The waiting period for these appointments can be several months. Eight countries require appointments prior to submission.
• Grace periods, a certain period after the approval of the changes, during which the pre-change material can still be imported and used, are broadly accepted in practice by regulators in the MENA region, reflecting the NRAs’ recognition of the complexity of managing global post-change supplies.
• Registering additional manufacturing sites per the WHO and EMA variation guideline is accepted by 11 countries (Algeria, Egypt, Iraq, Jordan, Kuwait, Saudi Arabia, Lebanon, Libya, Morocco, Tunisia, and Qatar) to enable supply flexibility. For other countries, registering additional manufacturing sites is either accepted on a case-by-case basis or accepted only for drug substances.
• Manufacturing site registration is an additional step before or in parallel with the scientific review process when adding a new manufacturing site. Ten countries (Iraq, Kuwait, Qatar, UAE, Bahrain, Oman, Lebanon, Jordan, Saudi Arabia, and Libya) in the MENA region require site registration. The timeline for site registration varies from 3 months to 12 months, which often delays the approval of a new manufacturing site.

Implications

These inconsistencies in regulatory requirements and timelines complicate lifecycle planning in an industry that must coordinate parallel submissions, track divergent approval pathways, and manage varying post-approval change expectations across multiple markets. This not only increases administrative burden but also poses risks to supply continuity and timely patient access.

Fragmented Risk-Based Change Categorization

Risk-based change reporting categorization plays a vital role in enabling efficient LCM by ensuring that regulatory scrutiny is proportionate to the level of risk a change presents. However, the current landscape in the MENA region shows significant fragmentation. Only a minority of surveyed countries (Bahrain, Egypt, Jordan, Oman, and Saudi Arabia) have adopted a risk-based change reporting category that aligns with international benchmarks such as the WHO variation guideline or the EU Variations Guidelines. This lack of harmonization complicates the submission strategy and can result in inconsistent expectations for the same post-approval change across different markets.

Unpredictable and Variable Approval Timelines and Reliance Gaps

Another major challenge is the lack of transparency on review timelines for PACs and limited use of reliance in PAC review. Nine countries don’t define review timelines in their regulations/guidelines, which creates unpredictability and inefficiencies in supply planning. Even where official timelines are defined, procedural hurdles such as administrative steps, pre-submission meetings, and limited resources often cause further delays. Moreover, reliance mechanisms remain significantly underutilized; only two countries (Egypt and UAE) are reported to actively implement reliance pathways for PACs, missing a key opportunity to optimize regulatory resources and accelerate patient access.

Systemic Bottlenecks: Submission Appointments

Persistent operational bottlenecks further hinder regulatory efficiency. In nine markets (Bahrain, Iraq, Kuwait, Lebanon, Oman, Qatar, Libya, Morocco, and Tunisia), the requirement to secure submission appointments adds unnecessary delays and disrupts planning cycles. This also reflects the resource challenges in most regulatory agencies to handle PACs and underlines the need to implement an efficient reliance mechanism to make the best use of regulatory resources.

Specific Country Requirements

Supply chain resilience is an important component of uninterrupted patient access to products. To ensure supply chain flexibility, a well-established approach is the registration of multiple manufacturing sites. Some countries in the MENA region (Bahrain, Oman, and UAE) have restrictions on multiple sites, which limits supply chain flexibility; most countries (10) (Iraq, Kuwait, Qatar, UAE, Bahrain, Oman, Lebanon, Jordan, Saudi Arabia, and Libya) require an additional regulatory step of site registration besides the scientific review, further delaying the approval of new sites.

Additionally, while 11 countries (Saudi Arabia, Oman, Bahrain, UAE, Qatar, Kuwait, Iraq, Libya, Jordan, Egypt, and Lebanon) have moved away from mandating local retesting of globally approved products, reflecting growing alignment with international best practices, three countries (Tunisia, Morocco, and Algeria) still require local testing or registration samples during or after the application of major variations, which also delays patient access and wastes material. Those retest requirements indicate room for convergence with international regulatory requirements and procedures.

The current landscape makes regulatory operations in the MENA region resource-intensive and unpredictable, with direct implications for patient access to continuous supply. Inconsistent PAC approvals can lead to fragmented product configurations, supply disruptions, and compliance risks.

Opportunities to Enhance Regulatory Efficiency

The MENA region stands at a pivotal point in its regulatory evolution.

As healthcare demands continue to grow and global supply chains become more interconnected, regulatory authorities across the Middle East and North Africa are increasingly recognizing the imperative to modernize their frameworks. Several countries have demonstrated progress toward adopting risk-based approaches, enhancing transparency, and fostering regulatory harmonization through their engagement with ICH and PIC/S. However, the broader adoption of internationally recognized standards such as those set by the WHO and the EMA remains essential to assure an uninterrupted supply of compliant, safe, and efficacious medicines and vaccines to patients globally.

To support this transformation, the authors recommend the following to help drive regulatory efficiency and foster alignment across the MENA region:

1. Converge risk-based categorization of PACs with WHO and EMA frameworks with reporting categories clearly defined for major, moderate, and minor risk classifications, to enable more efficient lifecycle management of medicinal products.
2. Define clear approval timelines for PACs and adhere to the published timeline to ensure predictability of PAC approval, facilitate supply planning, and reduce risk of supply disruptions.
3. Formalize reliance pathways for PACs, allowing national regulatory authorities to leverage assessments from established reference agencies. This not only accelerates decision-making but also optimizes resources while maintaining regulatory sovereignty.
4. Allow exemption of local testing (e.g., EDA) based on reliance principles and risk assessment to minimize redundant testing requirements, reduce waste of resources, and facilitate global supply continuity.
5. Streamline the regulatory procedure for adding a new manufacturing site by removing the additional site registration step, to align this procedure with international practice and accelerate its approval.

With coordinated action and continued dialogue among regulators, industry, and international partners, the MENA region can unlock meaningful regulatory efficiencies that will play a critical role in accelerating patient access to safe, high-quality medicines while fostering innovation and regulatory agility in years to come.