Clay&AssociatesAdvocates

Regulatory & Compliance

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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 business professional working on a laptop in a modern office, representing a foreign investor evaluating Special Economic Zone eligibility in KenyaRegulatory & ComplianceKenya’s Special Economic Zones: Who Actually Qualifies, and What the 2024 Amendment ChangedForeign investors evaluating Kenya often assume Special Economic Zone (SEZ) status is reserved for large-scale manufacturers, and skip…9 Sep 2026African legal team reviewing a cross-border licensing contract in a Nairobi officeRegulatory & ComplianceCross-Border Licensing Deals: What Multinational Pharma Should Know About Kenyan Contract LawWhen a multinational pharmaceutical company licenses a molecule, a manufacturing process, or a product dossier into Kenya, or…8 Sep 2026African pharmaceutical factory worker on a manufacturing production line in KenyaRegulatory & ComplianceManufacturing and Supply Agreements for Pharmaceutical Companies Operating in KenyaMost pharmaceutical products sold in Kenya are not made by the company whose name appears on the box.…3 Sep 2026African researchers analyzing samples in a clinical trial laboratory in KenyaRegulatory & ComplianceFrom Trial to Market: Structuring Sponsor-Site Clinical Trial Agreements Under Kenyan LawA sponsor-site clinical trial agreement is the contract that makes a clinical trial legally workable in Kenya. It…3 Sep 2026African doctor discussing medicine access and treatment options with a patient during a consultationRegulatory & ComplianceGlobal Drug Pricing Pressure and Kenya’s Access-to-Medicines DebateWashington's push for most-favoured-nation drug pricing is reshaping how global pharmaceutical manufacturers think about pricing everywhere, including in…3 Sep 2026African 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 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 2026 Talk to usNeed advice on Regulatory & Compliance?Speak to an advocate about your Regulatory & Compliance matter.Get in touch