Generic drugs: Kenya hosts regional Bioequivalence conference

The Pharmacy and Poisons Board (PPB), in collaboration with the Global Health Protection Programme (GHPP)–PharmTrain2 initiative, has kicked off a five-day regional workshop aimed at strengthening regulatory capacity in the assessment of bioequivalence (BE) studies.

The workshop brings together regulatory experts from Kenya, Ethiopia, Rwanda, Uganda, Egypt, Zanzibar, and Tanzania will help bridge critical gaps in the pharmaceutical manufacturing value chain and strengthen healthcare delivery across the region.

It is designed to enhance skills in the evaluation of clinical study reports—an essential aspect of regulating generic medicines.

Spearheaded by the Federal Institute for Drugs and Medical Devices (BfArM) and funded by the German Federal Ministry of Health (BMG), the PharmTrain2 initiative is delivering specialised training to four African regulatory authorities designated as Regional Centres of Regulatory Excellence (RCOREs).

Bioequivalence assessment plays a critical role in ensuring that generic medicines meet the required standards of quality, safety, and efficacy.

By bolstering this capacity, regulators can make more informed decisions and foster greater public confidence in generic alternatives.

The training also reinforces Kenya’s growing leadership in pharmaceutical research, having been recognised as a Centre of Excellence in Bioequivalence and Pharmaceutical Research.

The ultimate goal of the initiative is to build a strong network of Trainers of Trainers across Africa, create sustainable regulatory systems, support local manufacturing, and expand access to high-quality and affordable medicines on the continent.