Answers: getting US-approved, rare and new medicines in the Gulf
Plain answers to common questions about getting US-approved, rare, specialty or newly approved medicines in Saudi Arabia, the UAE, Kuwait, Qatar, Oman and the wider GCC. Each answer names the regulator or source it relies on. Sources were checked on 17 October 2026.
General information only. This is not medical or legal advice. Rules change, so confirm with the relevant regulator and your treating physician before acting. Sources marked "secondary source" are law firms, news reports or summaries rather than the regulator itself.
Reserve Meds helps families navigate these steps; contact us for your case. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner.
Getting started
How can I get a US-approved drug that is not registered in Saudi Arabia?
There are three main routes: a hospital-based access program, personal-use clearance, or waiting for local registration. The SFDA runs a Named Patient Program and a Special Access Program for patients with unmet medical needs, usually requested by the treating physician through a Saudi hospital. Some prescription medicines can also be cleared for personal use with a recent prescription or medical report. The right route depends on the drug, its storage needs and whether it is controlled.
Sources: SFDA, Regulatory Framework for Rare Diseases Drugs v1.0 (August 2026); SFDA, Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, v1.1 (2017)
What is a named patient program?
A named patient program is a regulatory route that lets a specific, identified patient receive a medicine that is not registered in their country, case by case. The request usually comes from the treating physician or hospital, not from the patient alone. In Saudi Arabia, the SFDA names its Named Patient Program and Special Access Program as routes that help patients with unmet medical needs, including people with rare diseases, reach therapies.
Sources: SFDA, Regulatory Framework for Rare Diseases Drugs v1.0 (issued 5 Aug 2026)
What is expanded access (compassionate use)?
Expanded access, also called compassionate use, is the US FDA pathway that lets a patient with a serious or immediately life-threatening condition use an investigational product, one not yet approved, outside a clinical trial. FDA criteria include that no comparable or satisfactory alternative therapy exists, that the patient cannot enrol in a trial, and that the potential benefit justifies the risks. Each request needs the manufacturer's agreement and FDA authorization.
Sources: US FDA, Expanded Access; 21 CFR 312.305, Expanded access requirements (via Cornell LII)
What is the difference between expanded access and a named patient program?
Expanded access is a US FDA pathway for investigational drugs that are not yet approved, while a named patient program is run by the patient's own country to allow a medicine that is not registered there. A drug that is FDA-approved but unregistered in Saudi Arabia would normally need the local route, such as the SFDA Named Patient or Special Access Program. An investigational drug sent abroad may need both FDA export compliance and local approval.
Sources: US FDA, Expanded Access; SFDA, Regulatory Framework for Rare Diseases Drugs v1.0 (August 2026)
US FDA pathways: expanded access and Right to Try
Can a patient outside the United States get a drug through FDA expanded access?
Possibly, but two countries' rules apply. FDA allows export of investigational drugs with fewer steps to listed countries such as Canada, Japan, Switzerland and EU states. For other countries, including the Gulf states, export generally needs an IND covering the use, marketing authorization in a listed country, or an exporter certification under 21 CFR 312.110(b). The manufacturer must agree, and the destination regulator, such as the SFDA, must also approve.
Sources: US FDA, Exporting Investigational New Drugs; SFDA, Special Access Program guidance v1.0 (2019)
Who requests expanded access, the patient or the doctor?
The licensed treating physician makes the request, not the patient. Under FDA guidance, the physician confirms that no suitable clinical trial is available, checks that the patient qualifies, asks the manufacturer whether it will supply the product, then submits the request to FDA and obtains review by an Institutional Review Board. Patients and families can start the process by raising the option with their doctor.
Does the drug company have to provide a medicine for compassionate use?
No. Neither expanded access nor the US Right to Try law obliges a manufacturer to supply its product. FDA tells physicians to contact the company first to see whether it will provide the investigational product, and the FDA application and ethics review steps follow only once the company agrees. For Right to Try, FDA states that the law does not require a sponsor to provide an eligible investigational drug.
Sources: US FDA, Physician Fact Sheet: Expanded Access; US FDA, Right to Try
How long does FDA take to respond to an expanded access request?
For a non-emergency single-patient request, the application takes effect 30 days after FDA receives it, or sooner if FDA tells the physician that treatment may begin. In an emergency, treatment may start as soon as an FDA reviewing official authorizes it, which can happen by phone before the written request is filed. After business hours, physicians can reach the FDA Emergency Call Center at 866-300-4374.
Sources: US FDA, IND Applications for Clinical Treatment (Expanded Access): Overview; US FDA, Expanded Access
How often does FDA allow expanded access requests to proceed?
Almost always, according to FDA's own data. In fiscal year 2023, FDA's drug center (CDER) received 1,326 non-emergency single-patient expanded access INDs and allowed 1,318 to proceed, and allowed all 634 emergency requests. The biologics center (CBER) allowed 173 of 192 non-emergency requests and all 136 emergency requests. These figures cover FDA review only and do not show how many requests manufacturers declined.
Sources: US FDA, Expanded Access (Compassionate Use) Submission Data
Can a drug company charge for a medicine given through expanded access?
Yes, but only with FDA's written authorization and within limits. Under FDA's February 2024 guidance, for an individual patient the company may recover only its direct costs of making the drug available, not administrative costs. Cost calculations generally need review by an independent certified public accountant, and any charge must be disclosed in the patient's informed consent document. Authorization usually lasts one year.
Sources: US FDA, Charging for Investigational Drugs Under an IND: Q&A (Feb 2024)
What is the US Right to Try law?
Right to Try is a US federal pathway, separate from expanded access, that lets eligible patients with a life-threatening condition seek certain investigational drugs without FDA reviewing each request. The drug must have completed a Phase 1 trial, must not be approved for any use, and must be under an active IND. The patient must have exhausted approved options and be unable to join a trial. Manufacturers are not required to supply.
Sources: US FDA, Right to Try
How can I check if a medicine is FDA-approved?
Search FDA's Drugs@FDA database, which lists most prescription and over-the-counter drug products approved since 1939 and links to the approved label. FDA also maintains the Orange Book, which lists products approved under new and abbreviated drug applications. If you need help, FDA's drug information line is 1-888-463-6332 and its email is druginfo@fda.hhs.gov. A product that does not appear may still be investigational.
Saudi Arabia
How can I check if a medicine is registered in Saudi Arabia?
Use the SFDA's public Drugs List on the SFDA website, which can be searched by trade name, scientific name, agent, manufacturer or registration number and shows strength, dosage form and price. The SFDA also publishes a Drug Approvals page listing newly registered products with their approval dates. If a product does not appear, it may be unregistered, and access would then depend on an SFDA access program or personal-use clearance.
Sources: SFDA, Drugs List (registered medicines search); SFDA, Drug Approvals list
How long does it take for a newly FDA-approved drug to be registered in Saudi Arabia?
There is no automatic timeline, because the manufacturer or its agent must first apply to the SFDA. Under the SFDA's reliance pathways, the performance target is 30 working days for the verification pathway, which requires approval and marketing by both FDA and EMA, and 60 working days for the abridged pathway, which requires one of them. Priority review for serious conditions cuts the standard target by 40%.
Sources: SFDA, Verification and Abridged Pathways guidance v3.0 (October 2025); SFDA, Priority Review guidance v5.3
Does Saudi Arabia have special rules for rare-disease medicines?
Yes. The SFDA issued a Regulatory Framework for Rare Diseases Drugs on 5 August 2026, applied from 5 September 2026. We give you a written timeline estimate for your case before you commit. It also notes that the SFDA Named Patient Program and Special Access Program help patients with unmet medical needs, including rare diseases, reach therapies.
Sources: SFDA, Regulatory Framework for Rare Diseases Drugs v1.0 (issued 5 Aug 2026)
What is the SFDA Special Access Program?
The SFDA Special Access Program lets a patient with a serious or immediately life-threatening condition receive a drug that is not registered in Saudi Arabia when no comparable alternative exists. The request comes from the manufacturer or sponsor, or from the licensed treating physician if there is no sponsor. Complete requests are processed within 24 working hours, with urgent cases prioritized. After approval, the SFDA issues an import permit for clearance.
Is it legal to bring cancer medicine into Saudi Arabia?
Yes for many medicines, if you follow the SFDA personal-use rules: a prescription or medical report approved by the treating institution within the last six months, the patient's ID, and no more than three months of supply. However, the SFDA excludes drugs requiring medical supervision from personal clearance, which can cover infused or injected cancer treatments. Those would need a hospital-based route such as the SFDA Special Access Program.
Sources: SFDA, Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, v1.1 (2017); SFDA, Special Access Program guidance v1.0 (2019)
Can I ship a prescription medicine to Saudi Arabia by courier for personal use?
Yes, non-controlled prescription medicines can be cleared for personal use when sent by courier or post, within limits. The SFDA allows up to three months of personal supply, and the request cannot be repeated within that period. Narcotic and controlled psychiatric drugs may not be sent through express or postal companies. Vaccines, blood or plasma derivatives and drugs requiring medical supervision are also excluded from personal clearance.
What documents does the SFDA require to clear a personal medicine shipment?
For a human prescription medicine sent by courier or post, the SFDA lists five items: the clearance application form; a prescription or medical report approved by the treating institution within the last six months, stating the illness, medicine, dose and treatment duration; a copy of the patient's ID; the purchase invoice; and the bill of lading. Requests are emailed to the SFDA drug office at the arrival port.
How do I travel to Saudi Arabia with controlled medicines?
Register and apply in advance on the SFDA Electronic Controlled Drug System (CDS), which has a traveller sign-up and a traveller journey guide. According to SFDA guidance reported in August 2025, applicants upload a prescription, a medical report, proof of identity and evidence of medical need, and list each medicine's trade name, active ingredient, strength and quantity. The SFDA personal-use rules also bar sending controlled drugs by courier or post.
Sources: SFDA, Electronic Controlled Drug System (CDS), with traveller sign-up and traveller journey guide; The Peninsula, Saudi Arabia introduces digital process for travellers carrying controlled drugs (16 Aug 2025, reporting SFDA) (secondary source); SFDA, Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, v1.1 (2017)
United Arab Emirates
Can I import a medicine into the UAE for personal use?
Yes. The UAE runs an electronic service called Issue of Permit to Import Medicines for Personal Use. Residents apply through it for approval, a guardian applies for minors, and travellers may optionally use it for narcotic and psychotropic medicines up to three months' need. The service is free. Federal medicine regulation is moving from MOHAP to the Emirates Drug Establishment (EDE), so check which portal currently hosts it.
Sources: UAE MOHAP, Issue of Permit to Import Medicines for Personal Use; Baker McKenzie, UAE enacts new pharma law (Federal Decree-Law 38 of 2024), Jan 2025 (secondary source)
What documents do I need for a UAE personal medicine import permit?
The core document is a prescription issued within the last three months and stamped by the treating facility, showing the patient's full name, medicine, dose, dosage form, treatment duration, issue date and physician's name. A medical report issued within the last year, with diagnosis and treatment plan, is listed as optional. Documents authenticated with the UAE PASS digital seal are accepted, and the service carries no fee.
Sources: UAE MOHAP, Issue of Permit to Import Medicines for Personal Use
Can I travel to the UAE with narcotic or psychotropic medicines?
Yes, within limits. The UAE personal import service says travellers may bring narcotic and psychotropic medicines in a quantity that does not exceed the patient's need for a maximum of three months. Applying for prior approval through the service is optional for travellers. If you apply, you need a prescription stamped by the treating facility and issued within the last three months. Check whether the service is now hosted by the Emirates Drug Establishment.
Sources: UAE MOHAP, Issue of Permit to Import Medicines for Personal Use
Who regulates medicines in the UAE now?
Federal Decree-Law No. 38 of 2024 on medical products came into force on 2 January 2025. Law firm Baker McKenzie reports that it supports the Emirates Drug Establishment (EDE) taking over medicine regulation from the Ministry of Health and Prevention (MOHAP), that activities such as import and distribution need EDE authorization, and that affected entities had a one-year grace period, which a Cabinet decision can extend. Some service pages still name MOHAP, so check both before applying.
Sources: Baker McKenzie, UAE enacts new pharma law (Federal Decree-Law 38 of 2024), Jan 2025 (secondary source)
How long does it take to get a newly FDA-approved drug in the UAE?
There is no fixed public timeline, because availability depends on when the manufacturer applies for UAE registration. Under the 2024 medical products law, activities such as import and distribution need authorization from the Emirates Drug Establishment. Until a medicine is registered, ask your treating physician whether a personal-use import permit could apply. That permit needs a prescription stamped by the treating facility and issued within the last three months.
Sources: Baker McKenzie, UAE enacts new pharma law (Federal Decree-Law 38 of 2024), Jan 2025 (secondary source); UAE MOHAP, Issue of Permit to Import Medicines for Personal Use
Kuwait, Qatar, Oman and the wider GCC
What documents do I need to import a prescription medicine into Kuwait?
For certain prescription medicines, especially narcotic and psychotropic drugs, Kuwait requires clearance before travel. The US Embassy in Kuwait advises getting written or electronic clearance from Kuwaiti officials abroad before boarding and presenting it to customs, with a 15 or 30 day supply limit. Ministerial Decision 302/2025, effective 15 December 2025, requires medical reports or prescriptions approved by Kuwaiti authorities abroad.
Sources: US Embassy Kuwait security alert on prescription medicines (via OSAC); HFW, New decisions issued in Kuwait under the Ministry of Health (Dec 2025) (secondary source)
Can a medicine with no alternative in Kuwait be registered there?
Yes, there is a specific route. Kuwait Ministry of Health Resolution No. 100 of 2023 added a provision allowing registration, at the request of ministry authorities, of medicines used to diagnose, treat or prevent disease that are registered with international regulators and have no alternative on the Kuwaiti market. Requirements are set by the ministry's medicine registration department. The request comes from ministry authorities rather than from patients.
Sources: GCC BDI, Kuwait MOH restrictions on supply of non-registered medical products (May 2023) (secondary source)
How long does it take to get a newly FDA-approved drug in Qatar?
No fixed official timeline is published. A new medicine must be registered with Qatar's Ministry of Public Health, whose Pharmacy and Drug Control Department handles product registration and import control, and the process starts only when the company applies. For context, a 2022 study of the GCC centralised review found average approval times for new medicines fell from 838 days in 2015 to 321 days in 2019.
Sources: Qatar MOPH Pharmacy and Drug Control presentation, Ensuring access to medicines in Qatar (Qatar University conference); Hashan et al., Evaluation of the GCC Centralised Regulatory Review Process, Pharmaceutical Medicine 36(4), 2022 (secondary source)
Can I bring controlled medicines into Qatar?
Yes, with limits and documents. Since August 2026, Qatar's Ministry of Public Health has run an electronic permit system at fli.moph.gov.qa for travellers carrying controlled medicines. We give you a written timeline estimate for your case before you commit. Apply at least five working days before travel. MOPH guidance allows up to 10 days of narcotic medicines and up to 60 days of psychotropic medicines.
Sources: The Peninsula, MoPH launches electronic permit system for travellers carrying controlled medicines (5 Aug 2026) (secondary source); Qatar MOPH, Guide for travellers carrying narcotic and psychotropic medicines
What documents does Qatar require for travellers with controlled medicine?
MOPH guidance lists four documents: a prescription in English or Arabic issued within six months and stamped by a healthcare facility; a medical report from the last six months, stamped by the treating facility and attested by the Ministry of Foreign Affairs; a copy of the passport or Qatar ID; and a signed undertaking that the medicine is for personal use. Include the foreign physician's or clinic's phone number. Injectables need approval by a local facility.
Sources: Qatar MOPH, Guide for travellers carrying narcotic and psychotropic medicines
Can I travel to Oman with prescription medicine?
Yes. Oman's Ministry of Health allows up to three months of non-controlled prescribed medicine, supported by a medical report. Controlled drugs need prior approval and a certified medical report or a prescription in the patient's name issued within six months, and approval covers one month's supply. For non-residents, the released quantity may not exceed one month or the length of stay, whichever is less. Excess medicine is destroyed.
Sources: Oman Ministry of Health, What you should know if you have medications and want to travel
Does the GCC have a single drug registration?
The GCC runs a centralised regulatory review, but national regulators still decide on their own markets. A 2022 study in Pharmaceutical Medicine reported that average review times for new medicines under the GCC process fell from 838 days in 2015 to 321 days in 2019, after reforms including a standard electronic dossier and a reliance strategy. The SFDA, for example, also runs its own national registration pathways.
Sources: Hashan et al., Evaluation of the GCC Centralised Regulatory Review Process, Pharmaceutical Medicine 36(4), 2022 (secondary source); SFDA, Verification and Abridged Pathways guidance v3.0 (October 2025)
Shipping, cost, insurance and safety
How are temperature-sensitive (cold-chain) medicines shipped internationally?
Under WHO's good storage and distribution practices (TRS 1025, Annex 7, 2020), medicines should travel under the conditions on their label, using a cold chain for temperature-sensitive products. Conditions should be monitored and recorded with calibrated instruments, shipping containers must not harm product quality, and transport temperature data should be reviewed on receipt. Any temperature deviation in transit must be reported to the supplier, distributor and recipient.
Sources: WHO, TRS 1025 Annex 7: Good storage and distribution practices for medical products (2020)
Can vaccines or blood products be imported for personal use into Saudi Arabia?
No. The SFDA's personal-use clearance rules list vaccines, human blood and plasma derivatives, and drugs requiring medical supervision among products that cannot be cleared for personal use. Products with unproven medical claims and herbal blends of unknown ingredients or source are also excluded. Patients who need such products would need a hospital-based route, such as the SFDA Special Access Program, rather than personal import.
Sources: SFDA, Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, v1.1 (2017); SFDA, Special Access Program guidance v1.0 (2019)
Will my insurance cover a medicine that is not registered in my country?
It depends on your policy. In Saudi Arabia, the unified health insurance policy covers medications within benefit limits, and the Council of Health Insurance updates an insurance drug formulary. We found no published Gulf rule guaranteeing cover for unregistered or imported medicines, so ask your insurer in writing before treatment starts, and keep the prescription, medical report and invoices for any claim.
Sources: Saudipedia, Basic Health Insurance Policy (secondary source)
Can UAE nationals get government-funded treatment abroad?
Dubai offers a formal route. The Dubai Health Authority runs a free Request Overseas Treatment service for UAE nationals through its Shefaa system. Applicants submit a copy of the patient's insurance card, passport and Emirates ID, plus an updated medical report. The service is available online at all times, and the DHA help centre can be reached on the toll-free number 800 342.
Sources: Dubai Health Authority, Request Overseas Treatment service
Does the FDA issue an export certificate for medicines I take for personal use?
No. FDA states that exporting human drugs for personal use does not fall within the Federal Food, Drug, and Cosmetic Act, that only commercial human drug exports fall under its purview, and that it does not issue export certificates for drugs used by individuals for personal use. FDA advises checking with US Customs and Border Protection and with the importing country, whose regulator sets the import documents.
What role does my physician play in getting an unregistered or investigational medicine?
The physician is central to every route. For FDA expanded access, the treating physician confirms eligibility, contacts the manufacturer, submits the request and arranges ethics review. For the SFDA Special Access Program, the licensed treating physician may submit when there is no sponsor and completes the clearance form after approval. Personal-use imports also depend on a recent prescription or medical report from the treating doctor.
Sources: US FDA, Physician Fact Sheet: Expanded Access; SFDA, Special Access Program guidance v1.0 (2019)
How can I avoid fake medicines when buying from abroad?
Buy only through licensed, verifiable channels and never without a prescription. WHO warns that substandard and falsified medical products are often sold online or in informal markets, and estimates that at least 1 in 10 medicines in low- and middle-income countries are substandard or falsified. FDA advises that legitimate US pharmacies require a prescription, are licensed by a state board of pharmacy, list a US address and have a pharmacist available.
Sources: WHO fact sheet, Substandard and falsified medical products (Dec 2024); US FDA, How to Buy Medicines Safely From an Online Pharmacy
How recent must a prescription be to import medicine into Gulf countries?
It varies by country, so check before the prescription is written. Saudi Arabia's SFDA requires a prescription or medical report approved by the treating institution within the last six months. The UAE personal import permit requires a prescription issued within the last three months and accepts an optional medical report from the last year. Other Gulf regulators set their own validity windows for prescriptions and reports.
Sources: SFDA, Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, v1.1 (2017); UAE MOHAP, Issue of Permit to Import Medicines for Personal Use
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