NAIROBI — Kenya is leading a regional effort to tighten oversight of generic drugs through a high-level workshop on bioequivalence an essential test to ensure the safety and effectiveness of non-branded medicines.
The Pharmacy and Poisons Board (PPB), in partnership with the PharmTrain2 initiative under the Global Health Protection Programme (GHPP), launched the five-day workshop on Monday in Nairobi. The training is focused on building expertise in assessing clinical study reports, which form the backbone of approvals for generic medications.
Regulators from seven countries ;Kenya, Ethiopia, Rwanda, Uganda, Egypt, Zanzibar, and Tanzania are participating. The goal is to close regulatory gaps, improve drug quality, and strengthen public trust in generic alternatives.
“Bioequivalence assessment is key to ensuring that generic medicines meet the same quality, safety, and efficacy standards as original products,” said a statement from the PPB at the event.
The workshop is being delivered through support from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and is financed by the German Federal Ministry of Health. Four African countries designated as Regional Centres of Regulatory Excellence (RCOREs) are receiving specialized training under the PharmTrain2 initiative.
Kenya has taken a lead role in this field and was recently recognized as a Centre of Excellence in Bioequivalence and Pharmaceutical Research. The country aims to use this recognition to support a stronger drug approval process and to encourage domestic pharmaceutical manufacturing.
The training also serves a broader purpose. Organizers said it is intended to establish a network of Trainers of Trainers who will expand regulatory skills across the continent. This approach is expected to support local drug production and widen access to affordable medicines.
The move comes at a time when demand for lower-cost treatment options is rising, especially across public health systems stretched by chronic diseases and limited budgets.
With generic drugs playing an increasingly vital role in Africa’s healthcare delivery, officials say the workshop marks a critical step toward building trust and ensuring patients get medicines that work.
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