Table 1.
National pharmacovigilance act, regulation, policy, and guidelines in Ethiopia, Kenya, Rwanda, and Tanzania
| Country | Act | Regulation | Policy | Guideline (s) |
|---|---|---|---|---|
| Ethiopia | Proclamation No. 661/2009 | Regulation No. 299/2013 (2013) | The Ethiopian Health Policy (2000) | Guideline for Adverse Drug Events Monitoring [Pharmacovigilance] (2014) |
| Kenya |
1. Pharmacy and Poisons Act, chapter 244 (1956) 2. Health Act (2017) |
2018 Pharmacovigilance guidelines (draft) | Health Sector Policy (2015) | Pharmacovigilance guidelines (2009) |
| Rwanda | Law Nº 003/2018 of 09/02/2018 | X | Rwanda Pharmacy Policy (2016) | Pharmacovigilance guidelines (2012) |
| Tanzania | Food, Drug and Cosmetics Act of 2003 |
1. Pharmacovigilance regulations (2018) 2. Regulations on registration of medicinal products (2015) |
The Tanzania National Drug Policy (1991) | National Guidelines for Monitoring Medicines Safety (2018) |
X missing/not available