Kenya Profile Updated in ClinRegs
June 26, 2020
The Kenya profile in ClinRegs now includes the following updates:
- Amendments to the Pharmacy and Poisons Act, enacted through the Health Laws (Amendment) Act, 2019 (See Regulatory Authority and Investigational Products topics)
- An updated version of the Guidelines for the Conduct of Clinical Trials in Kenya (See Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics)
- New legislative requirements in the Data Protection Act, 2019 (See Definition of Sponsor, Quality, Data & Records Management, Documentation Requirements, Required Elements, and Children/Minors)
- A sample informed consent form from Kenya’s Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) (See Documentation Requirements)