Will North Africans find harmony in medicine regulations?

In 2009, the African Union Development Agency, the World Health Organization, and multiple partners came together to tackle the pressing need for a more robust and efficient medicines regulatory framework across Africa.

The sluggish medicine registration and approval processes in Africa have long caused significant delays to patients’ access to priority medicines. Weak regulations have also allowed substandard and falsified medicines to enter the market unchecked, posing a serious public health risk.

Their solution was to launch the African medicines regulatory harmonization intiitive (AMRH), an umbrella initiative that will coordinate regional harmonization programs Through Africa’s regional economic communities (RECs).

The idea was if national medicines regulatory authorities within each regional bloc can harmonize their requirements for medical product regulation, coordinate their activities, trust and rely on one another’s assessments, it could significantly enhance regulatory efficiency – and make it easier and faster to register medicines and bring them to market.

In 2012, the East African Community became the first to launch its regulatory harmonization program, resulting in a 40-60% reduction in approval timelines for certain branded medicines—similar efforts spread across other regional blocs, covering most of the continent.

However, when the African Medicines Regulatory Harmonization (AMRH) initiative marked its 15th anniversary in Maputo, Mozambique last November, North Africa remained the only region without a regional regulatory harmonization program. Still, the prospects for regional cooperation are far from bleak, with steps being taken to explore collaborative initiatives.