Table 3.

Content of medicine laws and some regulatory activities of Ethiopia, the three African countries and EU

#	Content of the law		Ethiopia	Tanzania	Uganda	South Africa	EU
1	Product classification	Human medicine	•	•	•	•	•
		Veterinary medicine	○	•	•	•	•
		Medical devices	•	•	•	•	•
		Blood & blood products	•	•	•	•	•
		Tissue transplant	•	•	•	•	•
		Cosmetics	•	•	•	•	•
		Narcotics & psychotropic	•	•	•	•	•
		Herbal products	•	•	•	•	•
		Functional foods	•	•	•	•	•
		Food and additives	•	•	•	•	•
		ATMP	○	○	○	○	•
		Border-line products	○	○	○	○	•
2	Regulatory functions
	2.1. Product assessment and registration	Human medicine	•	•	•	•	•
		Veterinary medicine	□	•	•	•	•
		Herbal products	•	•	•	•	•
		Biological products	•	•	•	•	•
		Cosmetics	•	•	•	•	•
		Foods and additives	•	•	•	•	•
	2.2. Premise licensing	Manufacture	•	•	•	•	•
		Importers /wholesalers	•	•	•	•	•
		Retail outlets	○	•	•	•	•
	2.3. Inspections	GMP inspection	•	•	•	•	•
		Supply chain inspection	○a	•	•	•	•
	2.4. Quality control		•	•	•	•	•
	2.5. Pharmacovigilance		•	•	•	•	•
	2.6. Control of product promotion		•	•	•	•	•
	2.7. Clinical trial control		•	•	•	•	•
	2.8. Import/export control		•	•	•	•	•
	2.9. Price control		○	•	•	•	•
	2.10. Sources of products regulated	Private manufacture	•	•	•	•	•
		Government manufacture	•	•	•	•	•
		Private import	•	•	•	•	•
		Government import	•	•	•	•	•
	2.11. Control of raw materials	Active pharmaceutical ingredient	•	•	•	•	•
		Excipients	•	•	•	•	•
	2.12. Registration harmonization		○	EAC and SADC	EAC	EAC and SADC	ICH

ATMP: Advanced therapy medicinal products; Border-line products: between medicinal products and food supplements, biocides, cosmetic products or medical devices.

•Present; ○Absent; EAC: East African community; SADC: South African development communities; ICH: International conference on harmonization; □not under FMHACA;

^aExcept importer/wholesalers, lower supply chains are regulated by regional state regulatory bodies in Ethiopia