Odokonyero Kennedy
A question I am often asked during conversations with pharmacovigilance (PV) colleagues in Africa is: How compliant are local African pharmaceutical manufacturers and marketing authorisation holders (MAHs) with PV regulations in their own countries?
My answer: compliance is inadequate in most countries.
This view is drawn from my experience interacting with local manufacturers and health authorities (HAs). While writing this newsletter, I also attempted to explore existing literature to support what may appear to be a “subjective” conclusion. However, relevant literature was difficult to find. I reviewed the most recent annual reports from HAs in Ghana, South Africa, Uganda, Rwanda, and Zimbabwe. While some reports provide data on compliance indicators — such as QPPV appointments and PSUR submissions — they do not stratify the data between local and foreign MAHs.
Zimbabwe, however, stands out. Its annual report indicates that all 280 MAHs in the country are compliant with PV Plan GVP and QPPV requirements. It implies that local MAHs are compliant as well. This is not surprising, considering the country’s mature regulatory environment.
Comfort Ogar from the United States Pharmacopoeia presented research findings at the ISoP Annual Meeting in Cairo last year, showing that much of the available PV funding and technical support is directed toward HAs. In contrast, when it comes to promoting sustainable local manufacturing of health products in Africa, the focus has largely been on “securing funding for manufacturers, improving regulatory instruments, and mobilising support to establish local markets,” according to a news report from Africa CDC last year. A similar emphasis was reiterated about a fortnight ago during the 39th Ordinary Session of the Assembly of the African Union, where countries made commitments to advance local manufacturing of health products. The Pharmaceutical Manufacturing Plan for Africa primarily discusses the roles of HAs in PV, with little mention of manufacturers’ responsibilities.
In response to Comfort’s presentation, I argued that it is not sustainable for local MAHs in Africa to wait for funding from development partners to build their PV systems. They should invest their own resources in PV activities, just as they invest in GMP. Ultimately, funding decisions are made by top management. Commitment to PV will only be realised when market access for their products is tied to compliance with all GXPs — including GVP — not just GMP.
HAs can play a pivotal role in strengthening the PV capacity of local manufacturers. One approach is through targeted GVP inspections of local manufacturers. I was pleased to learn that Uganda’s National Drug Authority (NDA) has begun rolling out such inspections this year. GVP inspections can help identify gaps in manufacturers’ PV systems, demand for corrective action plans, and effectively compel top management to allocate the necessary resources to address deficiencies. However, HAs must follow up on these corrective action plans to ensure implementation; otherwise, they risk remaining merely documented intentions.
As noted earlier, PV compliance by local manufacturers is not prominently featured in current efforts to drive local manufacturing of health products in Africa. This is where advocacy from the PV community becomes critical. We must ensure that we are present when strategies are being developed and advocate for robust systems to monitor the safety of locally manufactured products.
How will we see progress in PV compliance among local manufacturers? HAs should improve transparency by publicly sharing compliance metrics in their annual reports. For example, how many local manufacturers have appointed QPPVs? How many are submitting required safety reports? How many have undergone GVP inspections, and what are the most common findings?
The push for local manufacturing across Africa presents a unique opportunity. We can either rely on systems that prioritise volume and market access, or we can build systems that prioritise safety and public trust. The future of African pharmaceutical manufacturing will not only depend on factories and financing, but also on the strength of pharmacovigilance systems embedded within them. The time to integrate PV meaningfully into the local manufacturing agenda is now.
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Written by
Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]
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