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Executive Summary

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Local manufacturing of diagnostics has the potential to create revenues, jobs and high value exports and reduce health spending. It promotes capacity and know-how held by local researchers and entrepreneurs who can apply or adapt it to other problems (i.e. transferability), ensuring that products are designed for the needs of the local healthcare systems, and creating greater autonomy and resilience. Strengthening local research, innovation and industry while lowering healthcare costs lays a path for the lasting, systemic change required for low and middle income countries (LMICs) to deal with COVID-19, future pandemics and their day-to-day healthcare needs.

To enable all of these potential benefits, stringent regulation of locally manufactured diagnostics is essential to ensure that they are safe and effective. However, many LMIC regulatory bodies do not have mature pathways, legal texts and experience for regulating locally manufacturing of in vitro diagnostics (IVDs). 

AfriDx is a UK-Denmark-Ghana initiative to develop systems for the clinical diagnosis of Covid-19 designed to be manufactured in low and middle-income countries. We considered it essential to better understand the regulatory landscape in Ghana and any recommendation that could be made which would ease the path of local manufacturers to bring products to market. In this policy brief we describe the process for gaining regulatory approval of locally manufactured IVDs in Ghana. Ghana is generally considered to have a mature regulatory capacity and unlike many countries in Sub-Saharan Africa, it has a route for regulating locally manufactured IVDs.

We then propose the following key policy recommendations to facilitate future regulation of locally manufactured IVDs in Ghana:

  1. Efforts for regulatory alignment across the ECOWAS region should be accelerated. This could greatly enable local manufacturers to expand their markets to neighbouring countries without duplication of effort. Expansion is likely to be essential to collate sufficient market demand
  2. Regulatory bodies like the Ghana FDA should continue to provide support to local innovators and manufacturers through willingness to communicate, clear documentation and feedback mechanisms.
  3. Navigating the fragmented regulatory landscape and entering processes like WHO prequalification will often require external support from experienced IVD regulatory experts. As these skills are not common in Ghana, one action for an intergovernmental organisation or an international NGO would be to facilitate local manufacturers to find and access appropriate regulatory support.

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