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Kenya Urges African Regulators to Harmonise Health Product Rules

Kenya urges African regulators to harmonise health product rules

Kenya urges African regulators to harmonise health product rules

KBC Digital

What changed

Kenya is urging African medicines regulators to harmonise health-product rules, rely on one another’s assessments and strengthen markets for locally made products.

The call came from Pharmacy and Poisons Board Chairperson John Munyu at a Nairobi summit. Health Cabinet Secretary Aden Duale linked it to Kenya’s 2026–2030 strategy, which targets local production of at least 50% of essential health products.

Why it matters

The practical problem is dependence. Africa imports more than 70% of the health products it consumes, Duale said. That leaves countries more exposed when supply chains are strained or when products take too long to receive approval.

Shared regulatory systems could reduce duplicated work. A product assessed by one regulator might move more easily through another market if authorities trust the same standards and evidence. That would give African manufacturers a clearer path to sell across borders, while stronger surveillance and traceability would help regulators follow products after they reach the market.

Kenya says 13 pharmaceutical companies have started operations, with some already exporting. The country is also working toward WHO Maturity Level 3 regulation, alongside efforts to strengthen safety and traceability.

The harder part is execution. No binding regional agreement, timetable or financing commitment was announced, so the summit’s test will be whether regulators turn shared principles into compatible decisions and whether local manufacturers can produce enough of the products countries need.

Sources (1)
  1. KBC DigitalKenya urges African regulators to harmonise health product rules

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