Kenya Profile Updated
The Kenya profile in ClinRegs has been reviewed and updated with the following information:
- New regulations and updated guidelines issued in 2022 on the conduct of clinical trials in Kenya (See Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Product topics)
- New guidelines issued in 2022 on clinical trial conduct during a public health emergency (See Risk & Quality Management)
- The Pharmacovigilance Electronic Reporting System (PvERS), an online platform for reporting adverse events (See Safety Reporting)
- A new guideline issued in 2022 on the import and export of health products and technologies (See Manufacturing & Import)
- A webpage on the import permit process for pharmaceutical products (See Manufacturing & Import)
- Data protection regulations issued in 2021, including on registration of data controllers and processors (See Personal Data Protection)
- New guidelines issued in 2022 on inspections and inspection certifications during an emergency (See Scope of Assessment)
Sources Added During this Update:
(Guidance) Guidance Document on Regulatory Measures on GMP, GCP and GDP Certification During Emergencies (Cert-Emrgcy) (Effective February 1, 2022)
Pharmacy and Poisons Board
(Guidance) Guideline on Import and Export of Health Products and Technologies (ImpExp) (Effective February 1, 2022)
Pharmacy and Poisons Board
(Guidance) Guidelines for Inspection of Contract Research Organization (CRO-Inspect) (Effective February 14, 2022)
Pharmacy and Poisons Board
(Guidance) Guidelines for the Conduct of Clinical Trials During Public Health Emergencies and Pandemics in Kenya (CT-Emrgcy) (Effective February 1, 2022)
Pharmacy and Poisons Board
(Regulation) Data Protection (General) Regulations, 2021 (No. 263); Data Protection (Complaints Handling and Enforcement Procedures) Regulations, 2021 (No. 264), and Data Protection (Registration of Data Controllers and Data Processors) Regulations, 2021 (No. 265) (DataProtect) (No. 263 – Effective December 31, 2021, No. 264 – Effective December 31, 2021, and No. 265 – Effective February 11, 2022)
Office of the Data Protection Commissioner
(Regulation) Pharmacy and Poisons (Conduct of Clinical Trials) Rules, 2022 (No. 95) (CTRules) (June 9, 2022)
Pharmacy and Poisons Board
(Webpage) Import Permit for Pharmaceutical Products (KEN-8) (Current as of March 2, 2023)
Kenya Trade Network Agency
(Webpage) PvERS: the Pharmacovigilance Electronic Reporting System (KEN-6) (Current as of March 2, 2023)
Pharmacy and Poisons Board
Sources Revised During this Update:
(Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 3) (Effective February 1, 2022)
Pharmacy and Poisons Board, Ministry of Health