Kenya has taken a leading role in strengthening the regulation of generic medicines by hosting a regional bioequivalence conference that brings together regulatory experts from across Africa. The event, part of the PharmTrain2 initiative, is focused on enhancing the assessment of bioequivalence—a critical process that ensures generic drugs meet the necessary standards for quality, safety, and efficacy.
The workshop has attracted participants from Kenya, Ethiopia, Rwanda, Uganda, Egypt, Zanzibar, and Tanzania, and is aimed at building capacity in the evaluation of clinical study reports, which are central to regulating generic medicines. This skill development is expected to bridge critical gaps in the pharmaceutical manufacturing value chain, thereby improving healthcare delivery across the region.
Spearheaded by Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and funded by the German Federal Ministry of Health (BMG), PharmTrain2 is delivering specialized training to four African regulatory bodies designated as Regional Centres of Regulatory Excellence (RCOREs). Kenya, which has been recognised as a Centre of Excellence in Bioequivalence and Pharmaceutical Research, is among the key beneficiaries of this capacity-building program.
By enhancing the competencies of regulators, the initiative aims to support informed decision-making and build public confidence in generic alternatives. This is particularly vital for African countries, where access to high-quality, affordable medication remains a persistent challenge.
The long-term goal of the training is to develop a robust network of Trainers of Trainers across Africa. These experts will lead the charge in creating sustainable regulatory systems that support local pharmaceutical manufacturing and ensure the wide availability of effective generic drugs.
As Kenya positions itself at the forefront of pharmaceutical research and regulation, the country’s leadership in hosting such initiatives reflects a broader commitment to advancing healthcare outcomes not just nationally, but across the continent. Through efforts like PharmTrain2, Africa is making significant strides toward achieving medicine security and improving public health through stronger, science-driven regulation.
