EAC harmonisation and the cost of the second market

The East African Community medicines regulatory harmonisation framework is often presented as though registering in one member state carries a product into the others. It reduces duplication substantially. It does not remove the second filing.

What harmonisation genuinely removes

The framework aligns technical requirements and supports joint assessment across participating national authorities. The practical gain is that the scientific core of a dossier, the quality, non-clinical and clinical modules, is built once and travels. That is the expensive part of the file, and not rebuilding it per market is a real saving.

Joint assessment procedures also mean a single scientific review can inform several national determinations rather than each authority repeating the work independently.

What still has to be rebuilt

Determination remains national. Each authority issues its own marketing authorisation, and each retains requirements the framework does not displace:

• Local representation and applicant status in the market
• Labelling and packaging to national requirements, including language
• Local fees, forms and administrative modules
• National pharmacovigilance obligations and commitment tracking
• Post-approval variation handling, which is not automatically synchronised across markets

The last one is the most commonly underestimated. A portfolio registered in four markets carries four variation obligations, and they drift out of alignment quickly unless they are managed as one register rather than four projects.

Planning consequence

Treat the second market as a dossier adaptation exercise rather than a new submission, and budget for the administrative and lifecycle layer rather than the scientific one. The cost of market two is not a fraction of market one distributed evenly; it is concentrated almost entirely in the parts of the file that harmonisation deliberately left national.