Executive summary
The Middle East and Africa encompass diverse regulatory systems with no single regional regime. The GCC Drug Registration system partially harmonises requirements among Gulf states. The African Medicines Agency (AMA) treaty entered into force in 2021 but operationalisation remains in progress as of 2026. Each country independently regulates peptide medicines, compounding, and research-use products.
- Middle East authorities named here include SFDA, MOHAP, DHA, HAAD, and Israel's Ministry of Health.
- African authorities named here include SAHPRA, NAFDAC, PPB, FDA Ghana, MCC Zimbabwe, Tanzania FDA, and Rwanda FDA.
- Check a current national product record.
- AMA treaty and regional initiatives coordinate; they do not replace national approval.
Named authority directory
| Area/country | Authority named | Role described | Product record/source | Coverage limitation |
|---|---|---|---|---|
| Gulf states | GCC Drug Registration | Partially harmonises requirements and provides the regional pathway described, alongside national procedures | GCC and each national register | It does not establish one rule or one product status for the entire Middle East |
| Saudi Arabia | SFDA | National medicine registration and the compounding context described | SFDA | Saudi and GCC records must be read with their exact scope |
| United Arab Emirates | MOHAP, DHA, HAAD | Federal and emirate-level medicine and pharmacy roles | MOHAP plus the applicable emirate record | Roles and product records differ by level and activity |
| Israel | Ministry of Health Pharmaceutical Administration | Independent medicine authorization and pharmacy system | Israel Ministry of Health | Separate from GCC procedures |
| African regional initiative | African Medicines Agency | Treaty-based coordination being operationalised as of 2026 | AMA treaty | It did not replace national authorities or provide a continent-wide product authorization |
| South Africa | SAHPRA | National product regulation and section 21 access context | SAHPRA | The South African route does not establish another country's rule |
| Nigeria | NAFDAC; PCN for the compounding context | National product/import control and pharmacy-practice roles | NAFDAC | Product and professional-practice records are separate |
| Kenya | Pharmacy and Poisons Board | National registration, compounding, and import-permit roles | PPB | Kenya-specific record only |
| Other named African systems | FDA Ghana, MCC Zimbabwe, Tanzania FDA, Rwanda FDA | National authorities listed for country-specific verification | Current national authority record | This overview does not verify every country, product, or enforcement action |
Middle East
Authorities and legal categories
GCC (Gulf Cooperation Council): the GCC Drug Registration system provides a unified marketing authorisation pathway for Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE. Individual states also have national procedures.
SFDA (Saudi Food and Drug Authority): separate national registration for Saudi Arabia, also participates in GCC system.
MOHAP / DHA / HAAD (UAE): federal and emirate-level authorities for medicines regulation.
Israel Ministry of Health — Pharmaceutical Administration: independent regulatory system.
Approved medicines
Some national registers include Expansion of the abbreviation used in the monographs: glucagon-like peptide-1 receptor agonist. The atlas does not define the pharmacology of this class; see the monograph for what is documented about a specific compound. Sumber definisi: Neutral gloss; the abbreviation is printed on the tirzepatide monograph but the atlas does not define the class pharmacology · Glosarium, insulin analogues, GnRH analogues, and somatostatin analogues. Availability and authorization are country- and product-specific; an FDA or EMA authorization does not itself authorize supply in a Middle Eastern jurisdiction.
Compounding
Saudi Arabia: SFDA authorises compounding for individual patient needs under specified conditions; bulk peptide raw materials from unregistered sources are not permitted.
UAE: Federal Decree-Law No. 38/2024 governs pharmacy practice including compounding. Prescription-based, patient-specific.
Israel: Pharmacists Regulations 1986 govern extemporaneous preparation. Unregistered bulk substances cannot be used.
These examples do not establish a region-wide rule. Whether an unapproved peptide may be used in compounding depends on the current national instrument, product, facility authorization, prescription, and import status.
Import
In the Middle Eastern jurisdictions reviewed, commercial import generally requires product authorization, subject to national exceptions. Personal import policies vary by country:
GCC states generally permit limited personal import of approved medicines with a prescription.
Israel Regulation 29 permits import of unapproved medicines for personal use under specific conditions (prescription, quantity limits).
Research peptides for institutional use may be imported with appropriate permits.
Research-use-only products
No general regional "research use only" exemption was identified. The legal effect of a disclaimer depends on national law and the product's composition, claims, intended use, recipient, and supply chain. This page does not establish the rule for every country.
Enforcement examples
National authorities publish enforcement notices concerning unauthorized medicines. Peptide-specific frequency or regional enforcement rates were not verified for this atlas; consult the named regulator's current notice archive.
Africa
Authorities and legal categories
AMA (African Medicines Agency): treaty entered into force 5 November 2021. As of August 2026, the Agency is being operationalised. It will eventually harmonise regulatory requirements but does not replace national authorities.
WHO Prequalification Programme: provides independent assessment of medicines for UN procurement; used as reference by many African regulators.
National authorities:
SAHPRA (South African Health Products Regulatory Authority).
NAFDAC (National Agency for Food and Drug Administration and Control, Nigeria).
PPB (Pharmacy and Poisons Board, Kenya).
FDA Ghana, MCC Zimbabwe, Tanzania FDA, Rwanda FDA, etc.
Approved medicines
Authorization pathways and reliance on reference agencies differ by country. Some national registers contain GLP-1 agonists and insulins, but no continent-wide product availability claim should be inferred.
Compounding
South Africa: Medicines Act s. 22C permits compounding per prescription. Manufacturing licence required for anything beyond extemporaneous scale.
Nigeria: PCN (Pharmacists Council of Nigeria) regulations govern compounding. Bulk unregistered APIs cannot be used.
Kenya: Pharmacy and Poisons Act governs compounding; similar constraints.
Import
In the African jurisdictions reviewed, commercial import generally requires product registration or a permit. Section 21 of the South African Medicines Act allows access to unapproved medicines for individual patients on application.
Nigeria: NAFDAC NCS (Notice of Confiscation and Seizure) applies to unauthorised imports.
Kenya: PPB controls import permits; unregistered peptides are seized.
Research-use-only products
No continent-wide exemption or prohibition can be inferred from a "research use only" label. National law, intended use, claims, importer status, and the facts of supply control. Country-specific legislation must be checked.
Enforcement examples
SAHPRA, NAFDAC, and other national authorities publish medicine-enforcement notices. This overview does not quantify peptide-specific actions or infer uniform online enforcement across countries.
Practical interpretation limits
This is general regulatory research, not legal advice. Classification can turn on composition, claims, intended use, route, supplier role, and facts not captured by a product name.
Related atlas pages: global framework, cross-border supply, WADA and sport, and approved-product label index.
Primary sources
GCC Drug Registration. https://www.gcc-sg.org
SFDA. https://www.sfda.gov.sa
MOHAP (UAE). https://www.mohap.gov.ae
Israel MoH — Pharmaceutical Administration. https://www.gov.il (health section).
AU — AMA Treaty. https://au.int/en/treaties/treaty-establishment-african-medicines-agency-ama
SAHPRA. https://www.sahpra.org.za
NAFDAC. https://www.nafdac.gov.ng
Kenya PPB. https://www.pharmacyboardkenya.org
WHO Prequalification. https://www.who.int/teams/regulation-prequalification