Clay&AssociatesAdvocates

Insights

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.

African doctor using a smartphone, representing remote monitoring and telehealth elements in decentralized clinical trialsRegulatory & ComplianceDecentralized Clinical Trials: Should Kenya’s Regulators Get Ahead of the Trend?Decentralized clinical trials, where telehealth visits, local healthcare providers, and remote monitoring replace some or all of a…3 Sep 2026African healthcare worker preparing a vaccine dose, representing local pharmaceutical manufacturing capacity in KenyaRegulatory & ComplianceTRIPS Flexibilities and Local Pharmaceutical Manufacturing: What Kenya Can Learn from SenegalSenegal now hosts one of Africa's most closely watched vaccine manufacturing projects, built on a mix of development…3 Sep 2026A businessman reviewing documents at a table, representing the regulatory and compliance review process for medical device softwareRegulatory & ComplianceSoftware as a Medical Device: Where Kenya’s Current Framework Falls ShortThe Pharmacy and Poisons Board’s new guideline on medical device software gives Kenya real, detailed rules for AI-enabled…2 Sep 2026An African professional working on a laptop, representing software-based medical device regulation and complianceLife Sciences & HealthcareRegulating AI-Enabled Medical Devices: A Preview of What’s Coming to the PPBThe Pharmacy and Poisons Board published its Guideline on Regulation of Medical Device Software in Kenya on 16…2 Sep 2026A scientist using a pipette to prepare a sample during mRNA vaccine technology transfer laboratory workIntellectual PropertymRNA Technology Transfer: Legal Lessons for Kenya from the Afrigen and WHO Hub ProgrammesKenya BioVax Institute signed its technology transfer agreement with the Medicines Patent Pool on 25 September 2024, and…2 Sep 2026Health worker administering a vaccination to a patient in Africa, relevant to African Medicines Agency product registrationRegulatory & ComplianceWhat African Medicines Agency Ratification Means for Registering Products Across AfricaKenya ratified the treaty establishing the African Medicines Agency in November 2023, and the Agency itself was formally…2 Sep 2026Doctor 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 2026 Talk to usNot sure where to start?Tell us what you need and we will point you to the right person.Get in touch