Middle East Regulatory Policy Brief

This episode covers significant regulatory updates across key Middle Eastern sectors such as Consultation Paper, Warehouse, Digital Platform, Energy Security, and Spectrum Fee.

The Abu Dhabi Global Market Registration Authority has published a new consultation paper proposing enhanced strata regulations to replace the 2015 framework. Noteworthy changes include automatic establishment and legal recognition of Owners’ Associations, mandatory appointment of licensed managers, and strengthened regulatory oversight to align with broader real estate laws.

In Saudi Arabia, the Food and Drug Authority has introduced new digital licensing services for pharmaceutical and cosmetic warehouses, tenants, manufacturers, and sites. These include requirements such as commercial registration, municipal licenses, and environmental permits, streamlining compliance for sector stakeholders.

Additionally, a public consultation is underway in the UAE regarding amendments to spectrum fee regulations, inviting sector stakeholders to submit comments and request clarifications, emphasizing the ongoing focus on energy security and digital spectrum management.

For more information, visit the Carver Agents website.

Articles mentioned:

1. ADGM Registration Authority Publishes Consultation Paper on Enhanced Strata Regulations

1. مشورة عامة بشأن رسوم الطيف الترددي
2. سحب طوعي للتشغيلة BF25008690 من مستحضر: KRABEVA 400 mg
3. ترخيص مركز متابعة دراسات سريرية
4. وزارة البلديات والإسكان تُحدث اشتراطات محلات المثلجات.. لتنظيم النشاط وضبط متطلبات السلامة الغذائية
5. ترخيص مستودع مستحضرات صيدلانية وتجميلية
6. ترخيص مستأجر مساحة داخل مستودع
7. مصنع مستحضرات صيدلانية وتجميلية
8. رخصة موقع دواء

1. [Philippines]-backed oil stockpiling proposal draws Saudi [Arabia], UAE interest

This episode covers essential regulatory developments across the Middle East, focusing on compliance frameworks, sanctions enforcement, telecommunication policies, and service delivery improvements.

Key updates include the Saudi Food and Drug Authority’s new guide on quality requirements for chemically synthesized amino acid products, outlining detailed manufacturing and control standards to address immunogenicity risks. The United Arab Emirates has introduced a comprehensive digital participation policy regulating user conduct on official platforms, alongside commitments to enhance digital accessibility aligned with WCAG 2.2 AA standards to support visually impaired users.

Additionally, the Saudi Capital Market Authority reminds financial institutions of strict securities lending compliance, emphasizing client consent and suitability criteria. The UAE regulatory body also launched a new complaint submission service to facilitate feedback on procedures and service delivery.

For more information, visit the Carver Agents website.

Articles mentioned:

1. دليل متطلبات جودة مستحضرات الأحماض الأمينية المصنعة كيميائيا
2. سياسة المشاركة الرقمية
3. بيان النفاذية الرقمية

1. Counter Narcotics, Counter Terrorism, Iran-related, and Non-Proliferation Designations

1. هيئة السوق المالية تهيب مؤسسات السوق المالية بضرورة الالتزام بالمتطلبات التنظيمية لإقراض الأوراق المالية المدرجة

1. EU Closing Statement at the 15th United Nations Congress on Crime Prevention and Criminal Justice - 01.10.2026

1. تقديم شكوى

In this episode, we explore significant regulatory changes impacting healthcare and finance sectors across the Middle East. Topics include new safety information on semaglutide medications, digital transformation in healthcare licensing through Dubai’s Sheryan platform, and stringent sanctions imposed by the UAE on Bank Melli Iran.

The Central Bank of the UAE has enforced strict sanctions prohibiting all Bank Melli Iran branches in the country from engaging in financial transactions with Iran. This action aligns with anti-money laundering and terrorism financing laws to protect the UAE’s financial system integrity.

Dubai’s healthcare sector sees the launch of the Sheryan system, a digital gateway for licensing healthcare professionals and facilities. This platform streamlines licensing, ensuring standardized compliance and operational oversight. Additionally, the Dubai Health Authority mandates a one-year internship for medical and dental graduates, emphasizing clinical training and English proficiency requirements for international applicants.

In Saudi Arabia, updated safety information on semaglutide drugs highlights risks of non-arteritic anterior ischemic optic neuropathy (NAION), advising healthcare providers to monitor visual symptoms closely. The Saudi Food and Drug Authority also introduces an electronic service for reporting veterinary medicinal products, enhancing regulatory compliance in that sector.

For more information, visit the Carver Agents website.

Articles mentioned:

1. المصرف المركزي يفرض جزاءات صارمة بحق فروع بنك ملي إيران العاملة في دولة الإمارات
2. التعليم الطبي
3. سيماجلوتايد
4. نظام التراخيص الصحية في إمارة دبي "شريان"
5. الإبلاغ عن المستحضرات البيطرية

This episode of Carver's Middle East Regulatory Updates delves into critical topics such as Pharmacovigilance, Labelling, and Packaging Defects impacting the pharmaceutical sector, with additional focus on regulatory frameworks involving the Ministerio para la Transición Ecológica y el Reto Demográfico and the State Water Resources Control Board.

The Saudi Food and Drug Authority (SFDA) has issued a notification concerning a packaging defect affecting batch number 010524 of the pharmaceutical product ألفاكالسيدول. The defect centers on missing Arabic and English labeling on the packaging, prompting the SFDA to provide an English package leaflet as a corrective measure. Healthcare professionals are advised to review this leaflet thoroughly and counsel patients accordingly to prevent misuse.

This update underscores the importance of accurate labelling and patient information in safeguarding public health and maintaining regulatory compliance within the pharmacovigilance domain.

For more information, visit the Carver Agents website.

Articles mentioned:

1. ألفاكالسيدول

This episode delivers an in-depth review of critical regulatory updates impacting the GCC region, focusing on the Saudi Food and Drug Authority's latest enforcement and authorization activities, GCC capital market developments, and sanctions-related procurement challenges.

Highlights include the SFDA's decisive action against misleading medical device advertising that led to facility closures and legal referrals, underscoring the authority's commitment to truthful promotion and public health protection. Additionally, the SFDA granted marketing authorization for two innovative AI-enabled medical software solutions—Dental IQ and SAARIA—after rigorous clinical validations, marking a significant advancement in local healthcare technology.

On the operational front, the SFDA's CEO conducted a strategic review of workflows and technological systems at Jeddah Islamic Port to bolster regulatory oversight for imports and exports, aiming to enhance efficiency and collaboration with port authorities.

Capital market regulatory updates include Saudi Arabia’s approval of a major capital reduction for a ceramics producer and authorization for a securities advisory firm, reflecting ongoing market reforms. The episode also covers GCC-wide efforts to harmonize bond listings and integrate AI tools for market supervision.

For more information, visit the Carver Agents website.

Articles mentioned:

1. SFDA Detects Misleading Claims in Medical Device Advertisement and Takes Legal Action
2. Operation Economic Outcast Strikes Iran’s Global Terrorist Proxy Network
3. Treasury Grounds Iranian Airlines with Sweeping Sanctions Action
4. FinCEN Issues Whistleblower Bulletin on Iran-Related Illicit Finance
5. The Capital Markets Authority Participates in the 32nd Meeting of Heads of Capital Markets Authorities Committee in GCC Countries
6. SFDA Grants Marketing Authorization for Two Saudi-Developed AI-Enabled Medical Software Products for Dental and Ophthalmic Diagnosis
7. SFDA CEO Visits Jeddah Islamic Port to Review Operational Workflows
8. Approval for Capital Reduction of Saudi Company for Ceramic Pipes Production
9. Authorization for Wazan Al-Nomou Company to Provide Securities Advisory Services
10. FinCEN Issues Alert to Counter Iranian Procurement Efforts for Its Commercial Aviation Industry

This episode presents an in-depth review of recent regulatory announcements focused on patient safety, drug safety, and pharmacovigilance within the Middle East pharmaceutical sector.

Key updates include the SFDA's approval of updated educational materials for Atrasentan emphasizing teratogenic risks and mandatory pregnancy testing protocols. Additionally, patient safety communications for Denosumab Wyost address osteonecrosis of the jaw (ONJ) risks, with guidelines for dental assessments and oral hygiene. The introduction of an Adalimumab patient alert card highlights serious infection and malignancy risks, vaccination guidelines, and monitoring requirements.

The SFDA has also issued voluntary recalls for several pharmaceutical products such as Credanil, Lorivan, Bralix, and Clonotril due to quality and safety concerns, urging healthcare providers to halt dispensing affected batches and ensure patient consultation.

For more information, visit the Carver Agents website.

Articles mentioned:

1. G20 Chair’s Statement

1. أتراسنتان
2. دينوسوماب
3. أداليموماب
4. سحب طوعي لعدد من التشغيلات لمستحضر Credanil 100/25mg Tab
5. سحب طوعي لعدد من التشغيلات لمستحضر Lorivan 2mg Tab
6. هيئة السوق المالية تنشر أبرز الاستفسارات الواردة إليها في شأن طلب الحصول على الترخيص لممارسة أعمال سوق السلع والمعادن في المملكة
7. سحب طوعي لعدد من التشغيلات لمستحضر : Credanil 100/10mg Tab
8. سحب طوعي عدد من التشغيلات لمستحضر : Bralix 5/2.5mg Tab
9. سحب طوعي لعدد من التشغيلات لمستحضر : Clonotril 0.5mg Tab

This episode dives into significant regulatory changes affecting the Middle East financial and compliance landscape, including updates on OFAC sanctions, Iran-related restrictions, goAML system procedures, market inspections in Saudi Arabia, and the Suspicious Transaction Reporting framework.

Key highlights include the UAE’s comprehensive AML/CFT law updates, which mandate Virtual Asset Service Providers to register and report via the goAML platform, detailing obligations for Money Laundering Reporting Officers and Compliance Officers. The UAE Financial Intelligence Unit’s clarified STR process ensures enhanced scrutiny and timely reporting of suspicious activities.

On the international front, the U.S. FinCEN has proposed a rule to prohibit correspondent banking with Banque Misr UAE due to its role in Iranian shadow banking networks, emphasizing increased U.S. financial system safeguards. Meanwhile, Saudi Arabia’s Ministry of Environment, Water and Agriculture has intensified market inspections to ensure food safety and quality, aligning with Vision 2030 objectives.

For more information, visit the Carver Agents website.

Articles mentioned:

1. Understanding the Law
2. Policies & Guidance
3. FinCEN Proposes Rule that Would Revoke Banque Misr UAE’s Correspondent Banking Access to U.S. Financial Institutions
4. The STR Process
5. Treasury Launches Unprecedented Campaign Against Iranian Regime on Economic D-Day
6. Proposal of Special Measure Regarding Banque Misr UAE as a Financial Institution Operating Outside of the United States of Primary Money Laundering Concern
7. Removal of Syria's designation as a State Sponsor of Terrorism and Associated Sanctions List Updates; Iran-related Designations; Updates to Iran-related General Licenses

1. البيئة: اكتفاء ذاتي لعدد من المنتجات الغذائية في المملكة ورقابة للامتثال في أسواق النفع العام
2. الترخيص لشركة تنامي كابيتال للاستثمار في ممارسة نشاط إدارة الاستثمارات في أعمال الأوراق المالية، واستيفائها لمتطلبات بدء ممارسة العمل

1. Bilateral Arrangements and Cooperation

This episode covers essential regulatory developments affecting pharmaceutical products and international sanctions within the Middle East. Key topics include the SFDA's enforcement actions on Monobenzone 20% Cream and Selsen Shampoo, alongside updates on sanctions targeting Hizballah, Da’esh, and entities on the SDN List.

The Saudi Food and Drug Authority (SFDA) has mandated recalls of all batches of Monobenzone 20% Cream manufactured by SACO MEDICAL, citing non-compliance with pharmaceutical regulations. Healthcare providers are instructed to halt dispensing and quarantine stock for return. Similarly, Selsen Shampoo has been recalled due to regulatory non-compliance, with protocols in place for managing remaining supplies and patient advisories.

On the sanctions front, the U.S. Treasury has increased sanctions on Hizballah, targeting networks smuggling millions in cash. Additionally, updates include amendments to the UN Security Council's Da’esh and Al-Qaida sanctions list and designations related to counter-narcotics and terrorism financing. These developments highlight ongoing international efforts to combat illicit networks and enforce compliance.

For more information, visit the Carver Agents website.

Articles mentioned:

1. 海外の医薬品簡略審査についてのページを更新しました。
2. Treasury Increases Sanctions on Hizballah and Targets Network Smuggling Millions in Cash for Hizballah
3. Treasury Increases Sanctions on Hizballah and Targets Network Smuggling Millions in Cash for Hizballah

1. سحب جميع تشغيلات مستحضر Selsen Shampoo
2. سحب جميع تشغيلات مستحضر Monobenzone 20% Cream

1. Counter Narcotics, Counter Terrorism, Cuba-related, and Iran-related Designations; Issuance of Russia-related General License; Issuance of Associated Frequently Asked Questions
2. Security Council ISIL (Da’esh) and Al-Qaida Sanctions Committee Amends 21 Entries on Its Sanctions List

1. سحب جميع تشغيلات مستحضر Monobenzone 20% Cream
2. سحب جميع تشغيلات مستحضر Selsen Shampoo

This episode covers critical regulatory updates across sectors including Labelling, Telecommunication Equipment, Clindamycin, Clean Technology, and initiatives supporting a Net-Zero Economy in the Middle East. Listeners will gain insight into compliance requirements and technological advancements driving regional policy.

In the UAE, the Telecommunications Regulatory Authority has outlined comprehensive requirements for mobile device type approvals, supplier and SIM card outlet registrations, and customs clearance permits, ensuring all devices meet strict standards before market entry.

Saudi Arabia’s Food and Drug Authority has issued important labelling compliance rulings affecting pharmaceutical products such as Flindix and Clindamycin Hikma, emphasizing bilingual packaging and the inclusion of English package leaflets. Additionally, a safety alert on Aurum Adrenaline Injection highlights risks with incompatible needle-free connectors.

Significant progress is also noted in Saudi Arabia’s adoption of advanced technologies and artificial intelligence to bolster product safety across food, pharmaceutical, and medical device sectors. Meanwhile, the Communications, Space and Technology Commission has introduced a new website usage policy emphasizing user responsibilities and intellectual property protections.

For more information, visit the Carver Agents website.

Articles mentioned:

1. اعتماد النوعية

1. M.12451 KHAZNA / ENI / JV (2026-08-07)
2. Daily News 10 / 08 / 2026
3. M.12451 KHAZNA / ENI / JV (2026-08-10)
4. Isosorbide Dinitrate
5. Adrenaline and Calcium Chloride
6. Clindamycin

1. تعزيز سلامة المنتجات عبر التقنيات المتقدمة والذكاء الاصطناعي
2. سياسة الاستخدام

This episode delivers a comprehensive briefing on the latest regulatory developments affecting Service Level Agreements, financial markets, sanctions, MCIT regulations, and cybersecurity frameworks within the Middle East.

Listeners will gain insights into Saudi Arabia’s newly introduced Information Access Policy, which enhances government transparency by formalizing public information requests and protecting sensitive data. Additionally, updates from the Saudi Arabian Monetary Authority highlight new guidance on unlicensed financial activities, emphasizing the importance of verifying licensing to combat fraud.

Further, the Saudi Ministry of Communications and Information Technology has unveiled a new Service Level Agreement and Terms of Use for its electronic services portal, detailing user responsibilities, service quality standards, and compliance obligations.

For more information, visit the Carver Agents website.

Articles mentioned:

1. Information access policy
2. Treasury Dismantles Iranian Regime’s Global Clandestine Currency Networks
3. Treasury Sanctions Crypto Exchanges Funding Iran’s IRGC and Enabling Illicit Finance
4. Counter Terrorism and Iran-related Designations; Counter Narcotics Designations Removals; Issuance of Amended Iran-related Frequently Asked Question
5. Unlicensed Activities
6. Service Level Agreement
7. Terms of use
8. Regulations
9. Holidays and Working Hours

1. تغيير اسم شركة مضاربة المالية