Exploring Pharmaceutical and Life Sciences Regulations in Kuwait – Part I

Navigating Kuwait’s Pharmaceutical and Life Sciences Regulatory Landscape: (Part I of II)

In an era where regulatory certainty underpins public trust in healthcare systems, few institutions command the same global stature as the U.S. Food and Drug Administration (the FDA). Renowned for its rigorous pre-market evaluations and robust post-market surveillance, the FDA’s expansive mandate—from clinical trial oversight to adverse event reporting—serves as a benchmark for jurisdictions worldwide.

While Kuwait’s Ministry of Health (the MOH) operates within a different regulatory and healthcare ecosystem, its objectives reflect parallel imperatives: to safeguard patient safety, ensure therapeutic efficacy, and uphold supply chain integrity. The MOH plays a central role in governing the registration, importation, and distribution of pharmaceuticals and medical devices, balancing public health priorities with the demands of a rapidly evolving global life sciences sector.

Against this backdrop, artificial intelligence (AI) and machine learning (ML) are reshaping regulatory paradigms. These technologies hold transformative potential—from automating dossier validation to enabling predictive analytics for post-market surveillance. Across the Gulf Cooperation Council (the GCC), regulators are responding with a dual imperative: to modernize legacy frameworks and to harmonize regulatory standards through regional coordination. The GCC Centralised Drug Registration (the GCC-DR) system, led by the Gulf Central Committee for Drug Registration, has emerged as a key platform to streamline registration across member states—facilitating market access while reinforcing consistency in safety protocols.

As Kuwait engages with these shifts, it must navigate intersecting pressures: aligning with international frameworks such as those promulgated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (the ICH), addressing local market fragmentation, and responding to growing demand for personalized and precision-based therapies. This article examines Kuwait’s evolving regulatory landscape—analyzing current mechanisms, recent legal reforms, licensing pathways, customs and importation requirements, digital health innovations, and strategic considerations—to chart a path for U.S. and other foreign companies navigating this dynamic and opportunity-rich market

This Part I of two part series covers:

• Market entry (eCTD, MOH reforms)
• Pricing and reimbursement (Ministerial Decree 158/2023, Circular 104/2024)
• IP and data exclusivity
• Importation and customs
• Local agent/distributor requirements
• Digital health regulation

Part II will cover Forward-Looking Trends and Strategic Developments and include:

• ESG-linked regulatory trends in Kuwait’s healthcare/pharma sectors
• Anticipated regulatory reforms (e.g., GCC harmonization, digital health law, HTA implementation)
• Parallel importation regime and its strategic implications
• Competition Law No. 72/2020, particularly its potential impact on pricing strategies, market exclusivity, and distributor agreements
• Role of local manufacturing incentives or public-private partnerships

1. What are the key legislative and regulatory requirements governing the registration and approval of pharmaceuticals and medical devices in Kuwait?

Kuwait’s regulatory framework for pharmaceuticals and medical devices is overseen by the Ministry of Health (the MOH), primarily through its Drug and Food Control Administration, with import controls coordinated with the Kuwait General Administration of Customs. The cornerstone legislation, Ministerial Decree No. 361/2009, establishes the requirements for the registration, importation, and commercialization of pharmaceuticals, while the MOH’s Medical Devices Department applies risk-based standards aligned with the Gulf Cooperation Council (the GCC) Medical Devices Regulation (GMDR). As of May 27, 2025, Kuwait has advanced its regulatory alignment with international standards, notably through the adoption of the Electronic Common Technical Document (eCTD) format in March 2025, reflecting the International Council for Harmonisation (ICH) Common milestoned Technical Document (CTD) guidelines.

For pharmaceuticals, the registration process requires a comprehensive eCTD submission, including Module 1 regional specifics such as:

• A legalized Certificate of Pharmaceutical Product (CPP) with embassy attestation.
• Bilingual (Arabic/English) patient information leaflets adhering to MOH-approved templates.
• Halal compliance declarations for alcohol- or pork-free formulations.
• Price certification compliant with Circular No. 104/2024.
• Valid Good Manufacturing Practice (GMP) certificates from reference regulatory authorities (e.g., FDA, EMA).
• Full corporate disclosure via affidavits.

Decree No. 381/2023 introduced an accelerated pathway for essential medicines, granting one-year renewable import licenses with restrictions on secondary distribution, while Circular No. 104/2024 imposes dinar-pegged pricing controls and mandatory quarterly reporting. Foreign entities must appoint a Kuwaiti-registered local agent under Commercial Law No. 68/1980, and post-market obligations include 15-day adverse event reporting per Decree No. 381 amendments. Sharia compliance, mandated by MOH Resolution 551/2021, requires excipient verification, which can extend registration timelines if not addressed early. Clinical trial requirements, governed by MOH guidelines aligned with ICH-GCP standards, are increasingly scrutinized, particularly for innovative therapies, necessitating robust data on safety and efficacy.

Medical devices are regulated under Kuwaiti Standards (KWS), pending full adoption of the GMDR, which classifies devices into risk-based categories (Class I–IV). Manufacturers must submit a GCC Conformity Assessment Certificate from a notified body, a technical file demonstrating safety and performance per ISO 14971, Arabic labeling and Instructions for Use (IFUs), and ISO 13485 Quality Management System certification. Anticipated reforms in 2025 include the implementation of Unique Device Identification (UDI) systems to enhance traceability and strengthened post-market surveillance protocols, aligning with GCC-wide efforts to harmonize device regulations. The MOH also emphasizes enforcement through regular GMP inspections for pharmaceuticals and quality audits for devices, ensuring ongoing compliance.

For U.S. and foreign companies, navigating these requirements demands early engagement with a local agent, thorough preparation of technical documentation, and alignment with GCC harmonization initiatives, such as the GCC Centralised Drug Registration (GCC-DR) system, which streamlines regional market access. Both the pharmaceutical and medical device sectors require engagement with local regulatory consultants to navigate Kuwait’s evolving compliance landscape, including local language and procedural nuances, effectively. The pharmaceutical framework remains more mature, while medical device regulations are undergoing substantial modernization toward regional harmonization. Stakeholders should verify the latest MOH guidelines for any interim updates post-March 2025 to ensure full compliance.

Importantly, Kuwait’s shift toward ICH-aligned regulatory formats and GCC-wide harmonization positions it as an increasingly interoperable jurisdiction for multinational pharmaceutical and device companies, particularly those already engaged with FDA or EMA frameworks.

2. How have recent legal developments in Kuwait facilitated or impacted market entry for foreign pharmaceutical companies?

Kuwait’s regulatory landscape for pharmaceuticals has undergone significant reforms since 2023, reshaping market entry strategies for U.S. and foreign companies by balancing streamlined access with stringent compliance requirements. These developments, driven by the Ministry of Health (MOH), enhance regulatory predictability while introducing complexities that demand strategic agility from global players seeking to establish or expand their presence in this dynamic Gulf market.

A pivotal reform is the mandatory adoption of the Electronic Common Technical Document (eCTD) format in March 2025, aligning Kuwait with the International Council for Harmonisation (ICH) standards. For companies accustomed to eCTD submissions for the U.S. FDA or EMA, this harmonization simplifies dossier preparation, potentially reducing dossier preparation timelines significantly by leveraging existing documentation. The MOH’s integration of digital tools, including digital validation tools that may incorporate automation or AI features, further accelerates reviews, though companies must ensure compliance with Kuwait-specific requirements, such as bilingual (Arabic/English) patient information leaflets and Halal certifications under MOH Resolution 551/2021.

Ministerial Decree No. 381/2023 introduced an accelerated pathway for essential medicines, offering one-year renewable import licenses to address critical therapeutic needs. This creates opportunities for first-mover advantages, particularly for companies addressing priority therapeutic areas identified by the MOH. However, the non-transferable nature of these licenses necessitates careful selection of Kuwaiti-registered local agents under Commercial Law No. 68/1980, as termination or transfer disputes can delay market entry. The MOH’s rigorous enforcement, including regular audits, underscores the importance of robust local partnerships.

Circular No. 104/2024 imposes dinar-pegged pricing controls and quarterly reporting obligations, challenging profitability for premium-priced innovative therapies. Companies with flexible global pricing strategies or efficient supply chains are better positioned to navigate these controls, often employing indication-specific pricing or staged launches to maintain margins. The anticipated GCC mutual recognition framework, expected to progress in late 2025, promises to streamline regional market access through the GCC Centralised Drug Registration (GCC-DR) system, enabling companies to integrate Kuwaiti strategies with broader GCC plans.

For U.S. and foreign companies, these reforms lower traditional barriers through harmonized standards and expedited pathways but require sophisticated approaches to pricing, local partnerships, and compliance. Engaging local regulatory consultants to navigate language and procedural nuances is critical, as is verifying post-March 2025 MOH guidelines for any interim updates. By aligning with Kuwait’s evolving framework, forward-thinking firms can capitalize on this opportunity-rich market while mitigating regulatory risks.

3. How do Kuwait’s pricing regulations and reimbursement policies shape the commercialization of pharmaceuticals and medical devices?

Kuwait’s Pricing and Reimbursement Regime: Strategic Implications for Commercialization

Kuwait’s evolving framework for pharmaceutical pricing and medical device reimbursement significantly shapes commercialization strategies by combining regulated pricing controls with selective reimbursement pathways. While the regime is more centralized than in many other Gulf states, it offers both challenges and opportunities for foreign manufacturers, particularly those capable of aligning with Kuwait’s healthcare priorities and procedural requirements.

Pharmaceutical Pricing: Controlled and Exchange-Rate Sensitive

Pharmaceutical pricing is governed primarily by Ministerial Decree No. 158/2023 and MOH Circular No. 104/2024, which establish a multi-tiered reference pricing system. Imported products are subject to either (i) the lowest ex-factory price in the manufacturer's home country or (ii) the lowest verifiable price among Gulf Cooperation Council (GCC) states. This dual mechanism is further subject to quarterly recalibration based on Kuwaiti Dinar (KWD) exchange fluctuations, introducing pricing volatility that requires ongoing financial monitoring by market entrants.

The Drug Pricing Committee retains discretion to assess applications for premium pricing—especially for innovative therapies—on a case-by-case basis. However, applicants must demonstrate therapeutic differentiation and cost-effectiveness, often through comparative clinical data and pricing benchmarks from recognized markets.

Pricing is tightly linked to the Essential Medicines List (EML), last updated in December 2024. Products listed on the EML benefit from faster pricing approvals and access to the centralized procurement system. Recent expansions of the EML to include treatments for rare diseases and precision medicine categories reflect the Ministry of Health’s effort to balance innovation with affordability.

Medical Device Reimbursement: Procurement-Driven and Fragmented

Unlike pharmaceuticals, medical devices are not subject to a unified pricing or reimbursement framework. Public procurement—particularly through the Central Medical Stores (CMS)—remains the dominant channel. Prices are negotiated directly through tenders and are closely tied to device functionality and hospital demand rather than a structured reimbursement schedule.

There is no formal health technology assessment (HTA) pathway for devices yet, although high-cost capital equipment may be subject to ad hoc budget impact reviews. Reimbursement decisions are influenced by institutional discretion, particularly in public hospitals, and depend heavily on successful registration and inclusion in hospital-specific procurement lists.

Tender System: Market Access Bottleneck and Commercial Opportunity

Both pharmaceutical and device manufacturers face a centralized tendering process governed by Public Tenders Law Number 49 of 2016. The Ministry of Health typically issues annual or biannual tenders through CMS, and inclusion is effectively mandatory for public sector market access.

While tenders present high-volume opportunities, they also impose stringent compliance burdens, including:

• Submission of pricing justifications aligned with reference country benchmarks;
• Demonstrated supply continuity and local distribution partnerships;
• Adherence to MOH pharmacovigilance and post-marketing reporting obligations, especially after Circular No. 89/2024.

Kuwait does not yet employ formal therapeutic clustering within tenders, but functional grouping of products for procurement purposes is common, particularly for generics and medical consumables.

Private Sector and Out-of-Pocket Markets: Selective Flexibility

The private healthcare sector, accounting for approximately 25–30% of pharmaceutical spending, provides greater pricing and commercialization flexibility. Products not listed in the EML or CMS tender system can still be marketed to private hospitals, clinics, and pharmacies, often at manufacturer-set prices subject to MOH approval.

Direct hospital contracting, physician engagement, and formulary negotiations are central to private market access. Innovative therapies with strong clinical evidence may secure premium positioning if supported by localized real-world data or strong demand from key opinion leaders.

Looking Ahead: GCC Harmonization and Local Adaptation

The forthcoming GCC mutual recognition framework, including centralized pricing coordination, is expected to influence Kuwait’s regulatory environment by late 2025. While full harmonization is not yet in place, companies entering the Kuwaiti market should anticipate greater alignment with Saudi and UAE pricing methodologies over time.

In parallel, the MOH is reportedly developing internal pharmacoeconomic guidelines, although formal cost-effectiveness thresholds have not been published. Manufacturers may benefit from submitting simplified budget impact analyses for high-cost therapies to support pricing or reimbursement requests, particularly when targeting inclusion in the EML.

Conclusion

Kuwait’s pricing and reimbursement framework emphasizes affordability, predictability, and alignment with public health priorities. For foreign manufacturers, especially those offering innovative or high-cost therapies, successful commercialization depends on navigating reference-based pricing, building strong local partnerships, and engaging strategically with MOH decision-makers. Early alignment with regulatory and procurement expectations—particularly around pricing flexibility and supply chain assurance—can significantly improve both market access and long-term sustainability in this competitive but opportunity-rich landscape.

4. What legal considerations must U.S. and foreign companies address when entering Kuwait’s pharmaceutical market?

• a. What is the role of a local agent, and how is it regulated under Kuwaiti law?
• b. What are the key components of a compliant agency agreement for pharmaceutical distribution?
• c. How does exclusivity function within agency agreements in Kuwait’s pharmaceutical sector?
• d. What are the legal requirements and processes for transferring an agency agreement?
• Provides detailed guidance on operational and legal hurdles for foreign entities, tailored to client needs.

U.S. and foreign pharmaceutical companies entering Kuwait’s market must navigate a complex regulatory landscape, encompassing local agency requirements, competition law, and stringent health regulations. Governed by the Ministry of Health (MOH), Commercial Agency Law No. 13/2016, and Competition Law No. 72 of 2020, these frameworks demand strategic foresight to ensure compliance and capitalize on Kuwait’s growing life sciences sector, particularly for Fortune 200 firms.

a. Role and Regulation of Local Agents
Under Commercial Agency Law No. 13/2016, foreign companies must appoint a Kuwaiti national or Kuwaiti-majority-owned entity (at least 51% Kuwaiti ownership) as a local agent to distribute pharmaceuticals. The agent manages MOH product registration, import approvals, and compliance, including pharmacovigilance and price registration under Circular No. 104/2024. As of May 28, 2025, agents must adhere to serialization requirements (effective January 2024) for track-and-trace systems. Competition Law No. 72/2020 further requires agents to avoid anti-competitive practices, such as exclusive arrangements that restrict market access, with the Kuwait Competition Protection Agency (CPA) imposing fines up to 10% of annual turnover for violations.

b. Key Components of Compliant Agency Agreements
Agency agreements must be registered with the Ministry of Commerce and Industry’s (MCI) Commercial Agencies Register within two months to be enforceable. These should define product scope, territories, and the agent’s MOH obligations, such as registration and adverse event reporting. Performance metrics, commission structures, and termination clauses must comply with Law No. 13/2016 and avoid anti-competitive terms prohibited by Competition Law No. 72/2020, such as price-fixing or market allocation.

c. Exclusivity in Pharmaceutical Agency Agreements
The MOH typically requires exclusive distribution rights for agents, reinforced by a legalized letter of appointment, to ensure accountability for safety and compliance. While not explicitly mandated, this practice triggers protections under Law No. 13/2016, including compensation for non-renewal. Exclusivity must be structured to comply with Competition Law No. 72/2020, as overly restrictive agreements could violate Article 8’s prohibition on abuse of dominance, necessitating performance-based clauses to mitigate risks.

d. Legal Requirements and Processes for Transferring Agency Agreements
Transferring agency agreements, taking 3–6 months, requires MOH and MCI coordination. Steps include notifying the existing agent, settling obligations, and updating MOH product registrations with new appointment letters. The incoming agent must provide a qualified person for pharmacovigilance. MCI registration of the new agreement and cancellation of the prior one are mandatory. Competition Law No. 72/2020 may apply if transfers involve mergers exceeding CPA thresholds (e.g., KWD 500,000 in annual Kuwaiti sales), requiring pre-notification. Compensation to outgoing exclusive agents under Law No. 13/2016 is a key risk.

For U.S. and foreign companies, selecting agents with GCC expertise, drafting competition-compliant agreements, and planning for transfer risks are critical. Local regulatory consultants can navigate these complexities, and verifying post-2024 MOH and CPA guidelines ensures compliance in this opportunity-rich market.

5. What are the licensing requirements for establishing pharmaceutical manufacturing or distribution facilities in Kuwait?

Establishing pharmaceutical manufacturing or distribution facilities in Kuwait requires navigating a robust regulatory framework overseen by the Ministry of Health (MOH) and aligned with international and Gulf Cooperation Council (GCC) standards. Governed by Kuwait Law No. 28/1996 and Ministerial Decision No. 395/1997, these requirements ensure compliance with Good Manufacturing Practices (GMP), data protection, and market competition rules, demanding strategic planning for U.S. and foreign companies entering this opportunity-rich market.

For manufacturing facilities, companies must secure a manufacturing license from the MOH’s Pharmaceutical Registration and Control Administration, demonstrating technical capabilities, qualified personnel (including licensed pharmacists), and facility designs meeting GMP standards per ICH guidelines. A commercial license from the Ministry of Commerce and Industry (MCI), often coupled with an industrial license from the Public Authority for Industry, is required, alongside municipal approvals for construction and safety. Pre-licensing MOH inspections verify climate-controlled environments and process validation, with periodic audits every three to five years to maintain compliance. Recent incentives, such as preferential tender treatment for locally manufactured products, enhance the strategic appeal of establishing manufacturing operations, particularly for innovative therapies.

Distribution facilities require a wholesale distribution license from the MOH and MCI, ensuring temperature-controlled storage, cold chain transportation, and integration with MOH serialization systems implemented in January 2024 for track-and-trace compliance. Kuwait’s Competition Law No. 72/2020 mandates that distribution agreements avoid anti-competitive practices, such as market allocation, with the Kuwait Competition Protection Agency enforcing penalties up to 10% of annual turnover.

Data protection under Regulation No. 26/2024, effective February 2024, applies to patient and provider data in pharmacovigilance or digital platforms, requiring transparency and secure cross-border transfers. Licensing typically takes 12–18 months, and early MOH engagement, alongside local regulatory consultants, streamlines approvals. Companies should verify post-2024 MOH guidelines to ensure compliance with evolving standards, leveraging GCC harmonization for regional market access.

6. How are intellectual property rights and data exclusivity protected in Kuwait's pharmaceutical market?

Kuwait offers a dual system of protection for pharmaceutical innovations through both patent rights and regulatory data exclusivity. Patent protection is governed by Law No. 64 of 1999, as amended by Law No. 35 of 2016, under which patents are granted for a term of 20 years from the filing date. Kuwait follows a first-to-file system and requires local prosecution through registered agents. Pharmaceutical patents may be enforced before the commercial courts, which are empowered to issue preliminary injunctions in cases of urgency, including to halt potentially infringing acts prior to final judgment.

Kuwait is a member of the GCC Patent Office system, although in practice applicants often pursue parallel national filings to ensure enforceability and clarity regarding local scope. Patent term extensions are not currently available, so timing of regulatory filings is strategically important for innovators seeking to maximize market exclusivity.

In parallel to patent protection, Kuwait provides regulatory data exclusivity under the authority of the Medical Registration Department (MRD) within the Ministry of Health (MOH). While no specific statute governs data exclusivity, MOH policy prohibits generic applicants from relying on originator clinical and safety data during a defined exclusivity period. This protection is granted on a discretionary basis, and the exclusivity duration may vary depending on the therapeutic class and product complexity. For example, biologics and advanced therapies often benefit from longer periods of data protection in recognition of their development complexity and investment scale.

Although Kuwait lacks a formal patent linkage system, the MOH coordinates with the Kuwait Patent Office to ensure that generics are not registered if they infringe a valid patent. This coordination requires proactive engagement by patent holders, including submission of relevant patent documentation during the registration process. Companies are also encouraged to monitor the MOH’s registry to detect and challenge any potentially infringing submissions.

Kuwait participates in regional IP harmonization efforts under the GCC framework, and the government has signaled interest in aligning more closely with international standards, including TRIPS and WIPO-administered treaties. Innovators are advised to adopt a comprehensive IP strategy, combining local patent prosecution with robust regulatory monitoring, and to engage early with authorities to preserve exclusivity.

7. What are the key importation and customs controls for pharmaceuticals and medical devices entering Kuwait?

Pharmaceutical and medical device imports into Kuwait are subject to a layered regulatory and customs framework aimed at ensuring product safety, lawful market access, and supply chain integrity.

Pharmaceutical products must first be registered with the Ministry of Health (MOH) and accompanied by a valid import license from the Ministry of Commerce and Industry. The application must include a Certificate of Pharmaceutical Product (CPP) from the country of origin, attesting to GMP compliance, product licensing, and safety. Imports are classified under the Harmonized System (HS), primarily Chapter 30, and benefit from GCC preferential tariff rates of 0% to 5%, depending on the product category.

Imports requiring cold chain handling—such as vaccines and biologics—must comply with specialized clearance procedures, including temperature control documentation, use of qualified logistics providers, and presentation of real-time monitoring data. MOH Resolution No. 551/2021 also mandates bilingual labeling (Arabic and English) and, in many cases, Halal certification.

Medical devices must meet additional technical documentation requirements, including proof of ISO 13485 certification, valid MOH registration, and submission of a Free Sale Certificate. All documentation must be submitted via the MOH’s Medical Devices Registration System, which is now partially digitized.

Public sector procurement is centralized under the Central Medical Stores (CMS), which manages importation through annual tenders and coordinated logistics. Private sector imports, by contrast, are managed by licensed local distributors approved by the MOH. All importers must maintain detailed pharmacovigilance records and be ready for MOH audits, including verification of batch integrity and storage compliance.

Importation processes are being streamlined via the Kuwait National Single Window (KNZW) initiative, which enables electronic submission of customs documentation and facilitates inter-agency coordination. Additionally, Kuwait is expected to adopt serialization and track-and-trace requirements aligned with GCC Unified Customs Law and the GCC Central Drug Registration (CDR) initiative, particularly for high-cost or high-risk products.

Controlled substances are subject to a more stringent regime, requiring special authorization from the Drug Control Department, supported by enhanced documentation, tracking systems, and secure warehousing protocols.

8. How is Kuwait regulating digital health solutions and online pharmacies, and what opportunities exist for innovation in this space?

Kuwait’s regulatory environment for digital health is still developing, with no unified legal framework currently in place. However, several laws and recent policy initiatives have begun to establish foundational rules applicable to digital health services, online pharmacies, and emerging healthcare technologies.

Under current MOH regulations, online pharmacies are not permitted to dispense prescription medicines without a licensed physical pharmacy presence and the supervision of a registered pharmacist. This effectively restricts the operation of pure-play online pharmacies for prescription fulfillment, though non-prescription items and consultation services may be offered through licensed platforms.

Kuwait’s Electronic Transactions Law No. 20 of 2014 provides a legal foundation for digital signatures, electronic documentation, and telehealth interactions, supporting the rise of remote consultations and online prescription management. However, controlled substances may only be prescribed following in-person physician consultations, reflecting patient safety concerns.

The recent issuance of Data Protection Regulation No. 26 of 2024 marks a significant shift toward structured digital health compliance. The regulation imposes strict requirements for encryption, consent management, cybersecurity, and cross-border data transfers. Digital health platforms handling patient data must also register with the National Centre for Cybersecurity and demonstrate appropriate safeguards, particularly when offering services across borders or involving foreign cloud providers.

Digital therapeutics and software-as-a-medical-device (SaMD) solutions currently operate in a regulatory gray area. The MOH is reportedly reviewing classification and registration pathways, with future rules expected to require clinical validation, cybersecurity certification, and potential inclusion in the medical device registry.

The government’s e-health transformation agenda—including rollout of electronic health records, AI diagnostic tools, and remote monitoring solutions—offers a growing number of public-private partnership opportunities for technology providers. Pilot programs involving local hospitals and private technology vendors are already underway in areas such as remote patient monitoring and adherence management for chronic disease.

While comprehensive cross-border telehealth rules are not yet in place, the MOH is studying frameworks adopted in neighboring jurisdictions such as the UAE and Saudi Arabia. International digital health providers seeking to enter the Kuwaiti market must navigate licensing restrictions, data localization risks, and regulatory uncertainty, but may benefit from early engagement with regulators to shape future policy.