The Saudi FDA drug evaluation timeline in comparison with international counterparts: a retrospective observational study

ABSTRACT

Background

Regulatory agencies ensure the safety, efficacy, and quality of pharmaceuticals, influencing patient access to novel therapies. The Saudi Food and Drug Authority (SFDA) oversees drug evaluation in Saudi Arabia. This study evaluates SFDA’s drug review times compared to other international agencies and assesses characteristics and approval timelines of novel drugs approved by the SFDA and the U.S. Food and Drug Administration (FDA) in 2019.

Methods

A retrospective observational study analyzed drug evaluation times from the SFDA and six international agencies: FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA), and Swissmedic. The primary outcome was drug approval timeline, defined as days from submission to registration. Data on 48 novel drugs approved by the FDA in 2019 were collected and tracked for SFDA approval status through 2024. Descriptive statistics compared drug characteristics and evaluation times. A regulatory comparison used publicly available documents and reported timelines.

Results

SFDA and EMA showed shorter median approval times (∼6.5 months), while Swissmedic (14.5 months) and PMDA (10.6 months) had longer timelines. Among 48 FDA-approved novel drugs in 2019, 21 (43.75%) were approved by the SFDA by mid-2024; 23 (47.92%) were not submitted for SFDA review, impacting coverage. Small molecules dominated approvals for both FDA (58.33%) and SFDA (64%). Advanced therapies such as gene therapies and synthetic peptide analogs were absent from SFDA approvals, mainly due to non-submission. Median approval times were comparable (SFDA: 248 days; FDA: 243 days), with greater variability observed in SFDA timelines.

Conclusion

SFDA’s review timelines align with major regulatory agencies, supporting timely drug access. Further investigation into submission patterns and regulatory challenges may improve approval rates, especially for advanced therapies.

Background

The timely evaluation and approval of pharmaceuticals by regulatory agencies worldwide are critical for ensuring the safety, efficacy, and quality of treatments available to patients. Organizations such as the Saudi Food and Drug Authority (SFDA), the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, the Medicines and Healthcare products Regulatory Agency (MHRA), the Pharmaceuticals and Medical Devices Agency (PMDA), and Swissmedic each play a crucial role in this process, establishing specific criteria and timelines often tailored to local health priorities (Almoteiry et al., 2022; Health Canada – Canada.Ca, 2024). Each agency establishes specific criteria and timelines for drug approval, with some requirements tailored to local health priorities (Pharmaceuticals and Medical Devices Agency (PMDA), 2024; Swissmedic, 2024b). For some agencies obtaining prior approval from a recognized regulatory body, such as the FDA or EMA can enhance a company’s likelihood of approval. For instance, the SFDA offers expedited registration pathways – the verification pathway (up to 30 working days) and the abridged pathway (up to 60 working days) – for drugs that have already received approval from the FDA or EMA, aiming to accelerate patient access to vital medications. Timely approval of drugs is crucial to ensuring that patients have access to innovative and life-saving drugs upholding stringent regulatory standards(Saudi Food & Drug Authority, 2017; Thind & Kowey, 2020).

The efficiency of drug approval timelines significantly influences patient access to innovative therapies and the dynamics of the pharmaceutical market (Almoteiry et al., 2022; Saudi Food & Drug Authority, 2017). Delays in the regulatory review process can impede patient access to life-saving drugs and potentially stifle pharmaceutical innovation (Thind & Kowey, 2020). Comparative studies have revealed notable differences in drug review times among regulatory agencies. For example, the FDA has been observed to approve a higher number of new drug indications more rapidly than the EMA and PMDA, suggesting quicker adoption of novel drugs in the U.S. (Shizuya & Miyazaki, 2022). Additionally, research has indicated that Europe often prioritizes indications for chronic and complex diseases, while Japan tends to focus on drugs addressing specific regional health concerns (Shizuya & Miyazaki, 2022). These variations underscore the importance of comparative analyses to identify best practices and areas for improvement in drug evaluation timelines globally (Ebied et al., 2020; Federal Register, 2021).

Previous research has extensively explored drug approval timelines across various regulatory agencies. A study examining the FDA's novel drug approval process in 2019 highlighted the impact of expedited review pathways, finding median review times of 10 months for standard applications and approximately 8 months for priority applications (Ebied et al., 2020). The study noted that a substantial majority (62.5%) of these novel drugs were approved through expedited pathways, with a significant portion (41.7%) addressing rare diseases, demonstrating a commitment to addressing unmet medical needs (Ebied et al., 2020). Other studies have provided in-depth analyses of drug approval processes in the United States, Japan, and Europe, revealing substantial differences in review durations and underlying regulatory frameworks (Shizuya & Miyazaki, 2022; Thind & Kowey, 2020).

Despite the growing global interest in understanding drug approval timelines across regulatory bodies, limited published research specifically examines the SFDA’s regulatory performance in relation to its international counterparts (Shizuya & Miyazaki, 2022; Thind & Kowey, 2020). While the SFDA has implemented mechanisms to enhance the efficiency of its drug evaluation processes, existing literature largely focuses on Western countries (Saudi Food and Drug Authority, 2023). This leaves a critical knowledge gap concerning how national regulatory authorities in the Middle East, particularly the SFDA, compare with global benchmarks in terms of review timelines, use of expedited pathways, and approval trends across drug classes. The need for such a comparative analysis is underscored by the increasing globalization of drug development and the growing expectation for regulatory harmonization. For Saudi Arabia, where chronic and complex diseases are on the rise, timely access to innovative medicines is a public health priority (Almoteiry et al., 2022). Understanding how the SFDA performs relative to its international counterparts is therefore crucial not only for optimizing regulatory operations but also for positioning Saudi Arabia as a competitive and attractive market for pharmaceutical companies seeking global approvals.

This study aims to bridge this gap by assessing the characteristics and timelines of novel drugs approved by the SFDA and comparing them to novel drugs approved by the FDA in 2019. Novel drugs, distinct from generics, often represent groundbreaking first-in-class treatments or provide critical advancements for conditions with limited therapeutic alternatives, making their timely access crucial for patient outcomes. The FDA was selected due to their global regulatory leadership, distinct review models, and significant influence on pharmaceutical market access. Moreover, the 2019 FDA novel drug approvals were selected as a benchmark due to comprehensive publicly available data, allowing for comparative assessment against SFDA timelines up to 2024. This study also addresses this gap by examining the SFDA’s drug review timelines, comparing them with international agencies. By fulfilling these objectives, this study seeks to contribute to a deeper understanding of regulatory efficiency, identify areas for improvement, and ultimately facilitate global collaboration to enhance patient access to new drugs. This study also addresses this gap by examining the SFDA’s drug review timelines, comparing them with international agencies.

Methods

Study design

This study adopted a retrospective observational study design to assess the drug evaluation times of the Saudi Food and Drug Authority (SFDA) and compare them with international regulatory agencies. Additionally, it assessed the characteristics and timelines of novel drugs approved by the SFDA and FDA.

Data source

Data were extracted from available sources, including official SFDA reports and drug evaluation databases, to assess the drug evaluation times of the Saudi Food and Drug Authority. The study also extracted publicly available data on average drug approval timelines from selected international regulatory agencies annual report, including the U.S. Food and Drug Administration (FDA) (Food and Drug Administration, 2024), European Medicines Agency (EMA) (European Medicines Agency, 2023), Health Canada (Lexchin et al., 2021), Medicines and Healthcare products Regulatory Agency (MHRA)(Medicines and Healthcare products Regulatory Agency, 2024), Pharmaceuticals and Medical Devices Agency (PMDA) (Pharmaceuticals and Medical Devices Agency, 2024), and Swissmedic (Swissmedic, 2024a). Only publicly available regulatory reports, official agency timelines, and drug approval databases from the most recent years available (2023–2024) were included. Confidential or internal assessments were excluded. While efforts were made to ensure consistency, it is important to acknowledge that regulatory agencies vary in their reporting practices, particularly in whether they disclose submission dates, the use of expedited pathways, or reasons for delays and rejections. Such differences may introduce inconsistencies that affect cross-agency comparability.

Relevant data points, including exact drug submission dates, review durations, and approval dates, as well as the characteristics of novel drugs approved by the SFDA and FDA in 2019, were collected for analysis. The analysis of FDA novel drug approvals in 2019 was used as a benchmark, as the latest comparable report published for public with the drug characteristics. All novel drugs approved by the FDA in 2019 were included, and those drugs submitted in Saudi Arabia, according to the list of human drugs approved by the SFDA (updated in 2024), were compared. Noted that some drugs from the FDA's 2019 list were approved later by the SFDA, up until August 2024. Furthermore, ethics approval was not required for this study given its reliance on publicly accessible data.

Main measures

The primary study measurement was the evaluation times of drugs, measured as the duration (in days) from the submission date of the drug application to the date of regulatory approval. For the first objective, median approval time were compared for SFDA’s with other international regularity agencies for the latest available data which was ranged from 2020 to 2023. Moreover, standard review target and the accelerated review target were also compared. The ‘standard review target’ represents the typical timeframe for regulatory agencies to evaluate drug applications under normal procedures, as defined by each agency’s publicly stated guidelines. Similarly, the ‘accelerated review target’ refers to a shortened, expedited timeframe for the assessment of drugs that address unmet medical needs or offer significant public health benefits, also according to the specific criteria and timelines published by each respective agency.

For the second objective, Table 1 presents the main variables that were collected. For the 2019 FDA-approved drugs within Saudi Arabia, the drugs were categorized based on four categories (approved, unsubmitted, under registration, or rejected) was determined using the SFDA’s drug registration data. ‘Approved’ referred to drugs granted marketing authorization by the SFDA; ‘rejected’ included drugs that were formally denied approval by the SFDA; ‘unsubmitted’ referred to drugs not yet submitted to the SFDA for review; and ‘under registration’ indicated drugs currently under review by the SFDA. Moreover, they were described based on drug classes. All submitted drug in SFDA (including those approved, under registration, and rejected) were compared with drug approved by FDA in 2019 based on drug approval time in days. The drug approval time in days were calculated from submission dates to approval dates.

Table 1.

Study Variables.

Variable	Description
Drug name	Name of the drug undergoing evaluation
Submission Date	Date when the drug application was submitted
Approval Date	Date when regulatory approval was granted
Evaluation Time	Duration between submission and approval dates in days and months
Drug Characteristics	Active ingredient, drug class, and approved use

Statistical analysis

Categorical data were described using descriptive analysis (frequencies, percentages). Continuous data were expressed as mean ± SD or median and IQR, based on the distribution of data. Comparisons were structured around key regulatory domains: standard review target, accelerated review target, and average approval timelines. Data management and statistical analysis were performed using RStudio statistical software (USA).

Results

The Health Canada and PMDA has the longest standard review time target at 12 months, while the SFDA has a variable standard review time ranging from 4 to 8 months. In terms of accelerated reviews, the MHRA offers the shortest target period of 2–4 months, contrasting with the FDA's target of 6 months, indicating differing approaches to expedite the approval process across agencies. Table 2 highlights the review time targets for each regulatory agencies. Supplemental Table 1 summarizes the median approval timelines of several major regulatory agencies (including standard and accelerated). The SFDA and EMA had a notably shorter median approval time (6.5 months) compared to agencies like PMDA (10.5 months) and Swissmedic, which had the longest median time of 14.5 months.

Table 2.

Standard and accelerated review time targets by regulatory agency.

Regulatory Agency	Standard Review Target	Accelerated Review Target
U.S. Food and Drug Administration (FDA)	10 months (337 days)	6 months (180 days)
European Medicines Agency (EMA)	7 months (210 days)	5 months (150 days)
Medicines and Healthcare products Regulatory Agency (MHRA)	7 months (210 days)	2–4 months (60–110 days)
Health Canada	12 months (365 days)	6 months (180 days)
Pharmaceuticals and Medical Devices Agency (PMDA)	12 months (365 days)	9 months (270 days)
Swissmedic	11 months (330 days)	5 months (150 days)
Saudi Food and Drug Authority (SFDA)	4–8 months (120–245 days)	2–6 months (60–180 days)

The study analyzed 48 novel drugs approved by the FDA in 2019 and compared their status with approvals by the SFDA (Supplemental Table 2). Out of the 48 drugs, by the mid of 2024, SFDA approved 21 drugs (43.75%), 23 drugs (47.92%) had not been submitted for approval to SFDA, 2 drugs (4.17%) were under registration, and 2 drugs (4.17%) were rejected (Figure 1). Table 3 showed that the majority of drugs approved by both the FDA and SFDA were small molecules, accounting for 58.33% of FDA approvals and 64% of SFDA approvals. While both agencies approved five monoclonal antibodies (20% for SFDA and 10.42% for FDA), an observation was the absence of gene therapies and synthetic peptide analogs among SFDA approvals, despite these being approved by the FDA at 4.16% and 6.25%, respectively. This absence is due to these drugs not being submitted to the SFDA for review (Table 3).

Figure 1.

SFDA approval status of 48 novel drugs approved by FDA in 2019.

Table 3.

Distribution drugs included in the analysis based on drug class.

Drug Class	Frequency	Percentage	Frequency	Percentage
	FDA		SFDA
Antibody-drug conjugate (ADC)	3	6.25%	3	12%
Gene therapy	2	4%	0	0%
Monoclonal antibody (mAb)	5	10%	5	20%
Recombinant fusion protein	1	2%	1	4%
Small Molecule	28	58%	16	64%
Synthetic peptide analog	3	6%	0	0%
Other*	6	13%	0	0%
Total	48		25

*Other drug class includes diverse and heterogeneous modalities such as radiopharmaceuticals and other novel drug types not classified in the main categories.

Drug approval timelines

The FDA started receiving submissions earlier, with the earliest submission on May 15, 2017, while the SFDA's earliest submission was on April 24, 2019. Approval timelines between the two regulatory bodies showed similarities as in Table 4. The median submission-to-approval time was 248 days for SFDA and 243 days for FDA. The interquartile range (IQR) for SFDA was 154–361 days, while FDA's IQR spanned 183–359 days. SFDA approval times ranged from 74 to 720 days, while the FDA had a slightly shorter range of 31–627 days. On average, the approval process took 278.5 days (SD 176) for SFDA and 273.6 days (SD 114) for FDA. A majority of drugs in both agencies exceeded the 180-day target for approval, with 56.52% in SFDA and 79.17% in FDA. The SFDA data revealed that 52.17% of drug approvals were through expedited review pathway.

Table 4.

Drug approval timelines for 48 specific novel drugs approved by FDA in 2019 and their approval status by SFDA (by mid-2024).

Category	SFDA	FDA
Submission Date Min	4/24/2019	5/15/2017
Submission Date Max	5/8/2024	8/29/2019
Approval Date Min	1/23/2020	2/1/2019
Approval Date Max	6/25/2024	12/23/2019
Mean	278.5 days	273.6 days
SD	176.36	114.3
Median	248 days	243
IQR	154 days – 361 days	183 days – 359 days
Range	74 – 720 days	31 – 27 days
Exceed target of 180	13 (56.52%)	38 (79.17%)

Discussion

Overall comparison of approval timelines and review targets

This study assessed the drug approval timelines of the Saudi Food and Drug Authority (SFDA) in comparison with other international regulatory agencies. The SFDA demonstrated a commendable median approval time of 248 days, comparable to the FDA's 243 days and notably faster than agencies like Swissmedic (441 days) and the PMDA (322 days), underscoring its efficiency in facilitating timely access to treatments. When comparing review time targets, Health Canada and the PMDA shared the longest standard review target at 12 months, whereas the SFDA had a variable standard review period ranging from 4 to 8 months. For accelerated reviews, the MHRA offered the shortest target period of 2–4 months, contrasting with the FDA's 6-month target, highlighting diverse agency approaches to expedited approval.

Novel drug approval rates and submission patterns

The comparative analysis of 48 novel drugs approved by the FDA in 2019 revealed their subsequent approval status with the SFDA. By mid-2024, only 21 of these drugs (43.75%) were approved by the SFDA, with a significant portion, 23 drugs (47.92%), not submitted to the SFDA for review. The observed lower approval coverage for this cohort is primarily attributable to the absence of applications rather than review delays or inefficiencies. This trend of later submissions to non-U.S. markets has been observed in previous research, indicating a broader industry pattern that impacts drug availability in specific regions (Shizuya & Miyazaki, 2022; Vokinger et al., 2023). Previous research has highlighted that strategic pharmaceutical companies’ goals that may prioritize larger markets with established pathways (e.g. the U.S. or EU) before pursuing approval in other countries (Vokinger et al., 2023). Although, this may underscore the importance of understanding industry submission patterns, market dynamics, and potential barriers to submission in the Saudi market. Moreover, this highlights the need for further investigation of other factors that influence the availability of certain advanced therapies, such as gene therapies including regulatory capacity constraints or policy priorities.

Within the 48-drug cohort of this study, 2 (4.17%) novel drugs were rejected by the SFDA. While specific reasons remain undisclosed, these rejections may stem from differing benefit-risk assessments, SFDA's requirements for additional local clinical data, or unique regional health priorities, thereby underscoring challenges in harmonizing regulatory decisions across diverse agencies. The SFDA's novel drug approvals revealed a higher proportion of small molecules (64% of SFDA approvals) and monoclonal antibodies (20%). This distribution aligns with global trends where traditional drug classes typically receive more applications than advanced therapies (Eichler et al., 2008). However, the absence of gene therapies and synthetic peptide analogs among SFDA approvals in this cohort, despite their FDA approval, highlights an area for improvement. Given that novel drugs often address severe or rare conditions with limited treatment alternatives, Continued efforts of the SFDA’s to enhance its capacity to evaluate and approve these advanced therapies is essential as global innovation in these areas accelerates.

Variability in SFDA approval timelines

While SFDA approval times showed greater variability (ranging from 74 to 720 days compared to FDA's 2019 range of 31–627 days), this broader range may reflect a tailored approach to diverse drug applications. Such variability is not uncommon among regulatory agencies and can be attributed to factors like differences in dossier completeness, regulatory capacity, reference agencies, the use of expedited pathways, and evolving regulatory frameworks (Vokinger et al., 2023). Further research is essential to investigate these specific drivers and better understand the causes of SFDA's timeline variability.

Expedited review

The higher use of expedited pathways for novel drug by SFDA (52.17%) enhance to shorter review timelines for priority drugs. This approach mirrors international regulatory trends and aligns with best practices observed among leading agencies (Vokinger et al., 2023). For example, the U.S. FDA has significantly reduced review timelines for novel drugs, with a median approval time of approximately 10 months, largely due to the strategic use of expedited review mechanisms (Michaeli et al., 2024). In 2019, over 60% of FDA-approved drugs benefited from such pathways, particularly those addressing high-priority or underserved therapeutic areas (Ebied et al., 2020). Similarly, the SFDA’s increasing adoption of expedited reviews, especially for therapies targeting rare diseases or unmet medical needs, demonstrates a commitment to accelerating patient access to innovative treatments (Malhomaidan et al., 2023). These findings support continued efforts to expand and refine expedited review processes, ensuring that regulatory efficiency does not compromise safety or efficacy, while positioning Saudi Arabia as a proactive player in global drug access.

Strengths and limitations

The primary strength of this study lies in its comparative analysis of drug approval timelines across multiple regulatory agencies, offering valuable insights into how the SFDA's performance aligns with international standards. The focused examination of novel drugs – many of which lack generic alternatives – provides a relevant perspective on regulatory efficiency and access to innovative therapies that are vital for addressing unmet medical needs. However, several important limitations should be acknowledged. The study’s reliance on publicly available data from regulatory agencies restricts access to detailed submission-level information, such as precise filing dates, types of review pathways (e.g. standard vs. accelerated), and reasons for delays, withdrawals, or rejections. This limits the ability to account for key contextual factors that influence review durations. Moreover, the analysis was based on aggregated data without therapeutic class-level detail, preventing adjustment for variability in drug characteristics such as clinical complexity, indication type, or compound novelty as because regulatory agencies did not provide such details in their annual reports. Methodological inconsistencies across regulatory agencies further complicate comparisons, as it is often unclear whether reported timelines include only approved applications or also account for withdrawn, incomplete, or rejected submissions – introducing potential bias. Although efforts were made to match SFDA and FDA approvals by active ingredient and drug class, full comparability could not be ensured due to unverifiable differences in dosage forms, formulations, indications, and target populations, which may have contributed to observed variations in review times. Finally, the study primarily focuses on approval times and does not address other important regulatory milestones such as post-approval commitments, pharmacovigilance activities, or time to market access. A comprehensive understanding of regulatory performance requires consideration of the full product lifecycle, which was beyond the scope of this analysis due to data limitations.

Implications for practice

The findings of this study have important implications for policymakers and regulatory authorities in Saudi Arabia. As the SFDA continues to evolve, there is potential to enhance its role in approving high-innovation drugs and improve predictability in review times for pharmaceutical companies. Increasing the use of expedited review pathways for critical drugs, especially those targeting life-threatening conditions or rare diseases, could significantly reduce approval times. SFDA’s participation in international harmonization efforts, including its membership in the ICH, supports the alignment of regulatory standards and facilitates knowledge exchange.

Practices from other agencies such as Singapore’s HSA and Australia’s TGA show the use of reliance models and risk-based review. These experiences illustrate practical strategies for streamlining review processes and implementing efficient pathways for complex or innovative therapies. The SFDA’s current trajectory aligns with Saudi Vision 2030, which emphasizes healthcare modernization, digital transformation, and international collaboration. Several initiatives have been implemented to strengthen its regulatory capacity, including adoption of reliance pathways, active participation in global regulatory harmonization efforts, and strategic investments, and digital transformation in regulatory science. These efforts position the SFDA as a one of leader in regulatory efficiency, helping ensure timely access to innovative therapies in Saudi Arabia.

The SFDA might investigate about late submission of pharmaceutical companies for innovative drug classes. Furthermore, establishing or enhancing a robust pre-submission consultation service for pharmaceutical companies developing innovative drugs, a common best practice in regulatory systems, would provide early guidance on regulatory requirements, address specific challenges for novel drug classes, and streamline the application process. While the SFDA enforces post-marketing Risk Management Plans (RMPs), developing a formal pre-submission advisory framework could improve predictability for applicants, particularly for complex or high-risk products. Expanding the use of expedited review pathways for critical drugs, especially those targeting life-threatening conditions or rare diseases, may further reduce approval timelines. These measures would not only enhance the SFDA’s efficiency and scientific capacity but also foster a more attractive and predictable regulatory environment for innovative drug launches, ultimately ensuring faster patient access to cutting-edge treatments in Saudi Arabia.

Research gaps and future directions

This study highlights gaps that future research could address. Future studies could benefit from an expanded sample size of drugs and inclusion of additional countries to broaden the comparative scope. Additionally, investigating the factors that influence variability in review timelines, such as application complexities or number of submitted indications, could yield actionable insights. Longitudinal studies evaluating the impact of ongoing regulatory reforms in Saudi Arabia on approval timelines and patient access would provide valuable insights into the effectiveness of these changes.

Conclusion

This study highlights the SFDA’s drug approval performance compared to international benchmarks. While median approval times are comparable to leading agencies, variability in review timelines and limited approvals of advanced drug classes indicate areas for improvement. The SFDA could address potential delays from pharmaceutical companies and enhance processes through structured early engagement with sponsors.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Supplemental Material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/20523211.2025.2605398.