Clay&AssociatesAdvocates

Regulatory & Compliance

Your Business, Our Solutions.

Analysis and commentary on Kenyan law as it is practised: corporate, IP, regulatory, disputes and the industries we serve. Written by the advocates who do the work.

Doctor consulting with a patient at a fertility clinic in KenyaRegulatory & ComplianceThe Assisted Reproductive Technology Bill: Licensing Fertility Clinics and Regulating Surrogacy in KenyaKenya’s Assisted Reproductive Technology Bill would create the country’s first dedicated licensing regime for fertility clinics and its…2 Sep 2026Man examining a medicinal plant in the field for traditional knowledge and bioprospectingRegulatory & ComplianceAccess and Benefit Sharing Under the Nagoya Protocol: A Guide for Bioprospecting and Natural-Compound Sourcing in KenyaKenya ratified the Nagoya Protocol on access to genetic resources in 2014, and the domestic rules implementing it…2 Sep 2026Laboratory scientist analyzing a sample for export from KenyaRegulatory & ComplianceExporting Human Biological Samples from Kenya: KEMRI Approval, SERU Ethics Review and Material Transfer AgreementsExporting human biological samples out of Kenya for research is not governed by a single export law. It…2 Sep 2026Modern health facility building in Kenya, representing the current and pending facility licensing and accreditation frameworksRegulatory & ComplianceHealth Facility Accreditation Compared: The Health Act 2017 Versus the Incoming Patient Safety AuthorityKenya’s Health Act 2017 already promised a single national regulator for health products and facilities, but seven years…2 Sep 2026African healthcare worker reviewing facility compliance records on a tablet, representing quality and patient safety inspectionRegulatory & ComplianceThe Quality Healthcare and Patient Safety Bill: A New Facility Licensing and Accreditation RegimeThe Quality Healthcare and Patient Safety Bill, 2025 would build an entirely new licensing and accreditation authority on…2 Sep 2026Historic pharmaceutical regulatory building in East Africa, representing the transition from the Pharmacy and Poisons Board to a new regulatory authorityRegulatory & ComplianceThe Health Products and Technologies Regulatory Authority Bill: What Changes When the PPB Is ReplacedThe Health Products and Technologies Regulatory Authority Bill is still a bill, not an Act, but it is…2 Sep 2026African doctor with a stethoscope consulting a patient in a clinical settingRegulatory & ComplianceMental Health Facility Licensing in Kenya: A Legal GuideOperating a private mental health facility in Kenya without a licence from the Kenya Medical Practitioners and Dentists…2 Sep 2026African laboratory researcher examining a sample under a microscope in a genetic testing facilityRegulatory & ComplianceGenetic Data and Genomic Testing in Kenya: A Legal Compliance GuideGenetic data sits inside Kenya’s Data Protection Act as a named category of sensitive personal data, but the…2 Sep 2026Two African warehouse workers handling boxes in a medical supplies storage facilityRegulatory & ComplianceSelling to KEMSA: A Legal Guide to Kenya’s Pharmaceutical Procurement ProcessA pharmaceutical supplier navigating KEMSA procurement for the first time is often surprised to learn that responding to…2 Sep 2026 Talk to usNeed advice on Regulatory & Compliance?Speak to an advocate about your Regulatory & Compliance matter.Get in touch