Themes and Topics

Clinical trials in Africa – towards priority reviews for essential medicines

Some regulators have started to give priority reviews to essential medicines in registration. However, this is not matched with priority approval of clinical trials. How can the priority approval system be implemented and what resources are needed to improve efficiencies in the overall handling and approval of clinical trials?

Harmonization or convergence?

Harmonization has long been talked about, but little progress seems to have been made in Africa because of factors including variable geometry, national sovereignty and language. Increasingly there is a focus on convergence as an easier first step towards regional harmonization. What are the quick wins in this area? Should consideration be given to harmonization or convergence which goes beyond medicine regulation to clinical guidelines? What opportunities are available to industry for collaborations in harmonization and convergence?

Education and training

There is very little emphasis in the current pharmacy curricula in pharmaceutical logistics, supply chain management and the attendant regulatory framework and quality management systems. Can short training programmes be developed and how can they be quickly accredited? What are the opportunities for collaboration between universities and private training institutions in the education and training arena to build capacity on the Africa continent?

Local manufacturing for local needs

There has been de-industrialization in many African countries with global pharmaceutical companies retreating to global centres of excellence along with the entry of Indian – manufactured products. This may result in severe supply shocks and stock-outs. How can local and global companies play a role in ensuring security of supply of essential medicines?

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