Transforming Pharmaceutical Compliance Through Insight and Expertise
Our blog goes beyond sharing regulatory updates to provide practical, experience-based guidance for pharmaceutical businesses seeking to strengthen compliance and audit readiness. We offer insights drawn from real inspection scenarios, international best practices, and emerging trends within Kenya’s pharmaceutical sector and the wider African healthcare landscape.
Digital Pharmacovigilance: Real-Time ADR Monitoring in Kenya
Digital transformation continues to reshape Kenya’s health sector. One of the most impactful areas is digital pharmacovigilance, a modern approach that improves how adverse drug reactions (ADRs) are reported, analyzed, and prevented. Traditional reporting systems...
Pharmaceutical Waste Recycling: Turning Hazard Into Resource
Pharmaceutical waste remains one of the most challenging categories of healthcare waste worldwide. Hospitals, pharmacies, and medical facilities generate large volumes of expired, unused, or contaminated medicines each year. If this waste enters the environment, it...
Smart Stocks: Inventory Optimization for Kenyan Pharmacies
Inventory management has become a major determinant of success for pharmacies in Kenya. A well-optimized inventory ensures that essential medicines remain available, losses remain low, and patients receive timely care. As the pharmaceutical sector grows, many pharmacy...
Compliance in Clinical Trials: What Sponsors and Investigators Must Know
Clinical trials carry significant responsibilities. Both sponsors and investigators must ensure trials proceed ethically, safely, and in full regulatory compliance. Without clear adherence to compliance standards, research risks participant harm, data invalidation and...
Herbal & Complementary Medicines: How the PPB Ensures Safety and Quality
Herbal and complementary medicines have become more popular in Kenya. Many people prefer natural remedies for general wellness, chronic conditions, and preventive care. However, not every product on the market is safe. Because of this, the Pharmacy and Poisons Board...
Managing Medical Devices: Regulation & Guidelines under PPB
Managing medical devices in Kenya demands strict compliance with the standards set by the Pharmacy and Poisons Board (PPB). These rules protect the public, promote product quality, and ensure that only safe devices reach the market. In recent years, PPB has...
Laboratory Standards: PPB’s Quality Manual for Pharmaceutical Testing
When pharmaceutical products reach the Kenyan market, stakeholders must guarantee they meet rigorous quality standards. The Pharmacy and Poisons Board (PPB) has long mandated these standards and published guidance that laboratories must follow. This article unpacks...
Alcohol-Based Hand Rubs: Production Guidelines for Kenyan Pharmacies
Alcohol-based hand rubs (ABHRs) remain a key part of infection prevention in Kenya. Pharmacies across the country often produce these products to meet local demand, especially during public health emergencies. However, the Pharmacy and Poisons Board (PPB) and the...
Navigating Controlled Substances in Kenya
Managing controlled substances in Kenya demands attention to detail, strong systems and full regulatory compliance. This article walks you through the key steps—from licences to safe-storage to record-keeping—so you can operate confidently and legally. Understanding...
Guidelines on Reliance Mechanisms: Fast-Tracking Medicine Approvals in Kenya
n Kenya, regulatory efficiency matters. The Pharmacy and Poisons Board (PPB) has introduced a set of reliance mechanisms. These mechanisms allow the agency to leverage decisions from trusted regulators. In doing so, they speed up medicine approvals without...
How to Submit Changes to Registered Medicines in Kenya
When you hold marketing authorisation for a medicine in Kenya, it is vital to keep it updated. Regulatory authorities expect any change—minor or major—to be reported promptly. In Kenya the Pharmacy and Poisons Act (Cap 244) and the associated rules govern such...
Best Practices for Pharmaceutical Imports & Exports
In today’s global market, pharmaceutical supply chains face increasing risks and complexity. You must plan well, coordinate stakeholders, follow regulations, and deploy the right controls. This article guides you step-by-step through best practices for securing...