Why Harmonise?

Access to new products in Africa can be delayed, sometimes for years, due to complex and costly requirements for regulatory approval in some countries. Costs incurred by the manufacturers will be passed on to customers increasing the price of the goods.

• Approval processes in some countries are lengthy and not transparent, leading to costly delays.
• Approval processes vary between countries and manufacturers need to prepare different dossiers for each country, a lengthy and costly process.
• Duplication in facility inspections and clinical trials results in increased cost of goods, making products less affordable.
• Costly and lengthy registration processes are a disincentive to manufacturers to sell in those countries. They are also a deterrent to innovation and the development of new products.
• Setting international standards and streamlining the regulatory process could reduce the regulatory burden, lower costs and remove unnecessary delays to new products reaching patients in Africa.
• The burden on regulators of post market checks on quality could be reduced if networks of laboratories were to adopt common standards and proceedures.

Why harmonise IVD medical devices now?

There is a need to improve access to healthcare in Africa.

There is substantial investment in point-of-care diagnostics due to the recognition that they can improve access to healthcare and assist control of infectious diseases.

Rapid technological advances are driving innovation in diagnostics. It is recognised that over zealous regulation can stifle innovation.

There is currently a favourable environment for harmonizing.

For example

• The African Medicines Regulatory Program AMHP.
• The work of the Global Harmonization Task Force and International Medical Device Regulators Forum IMDRF
• The work of other regional hamonization bodies, including the Asian Harmonization Working Party AHWP  and the Latin American IVD Association ALADDIV