Nairobi/ Kenya is strengthening its use of trusted regulatory decisions to support more efficient assessment of health products.

Speaking on the “Regulatory Updates” panel at AfriSummit 2026, Dr. Purity Mutinda outlined the Pharmacy and Poisons Board’s abridged, expedited and immediate recognition pathways. These pathways draw on decisions by reference authorities, including the US FDA, EU Notified Bodies, TGA, Health Canada, PMDA and WHO.

She also highlighted the need to strengthen quality management system auditing, improve digital regulatory platforms, expand stakeholder engagement and use artificial intelligence in screening and evaluations. The Board is investing in continuous training for assessors and auditors and keeping pace with emerging technologies, including machine learning and software as a medical device.

Dr. Mutinda also emphasised collaboration with the African Medicines Agency to advance regulatory reliance across the continent.

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