Harmonisation of Standards for Pharmaceutical Products and Medical Devices

Supporting Africa’s Pharmaceutical industry under the umbrella of AATB

Towards a Solution

light of the COVID-19 pandemic and the progress made toward the implementation of AfCFTA, (effective from 1 January 2021), the Arab Africa Trade Bridges program recognized the need for a well-informed and appropriate prioritization strategy for the development and harmonization of standards. In this respect, the project’ “Harmonization of Standards for Pharmaceutical Products and Medical Devices” in Africa was designed and adopted by the AATB partners.

This project aimed at providing a “quick win, under the response phase to COVID19. The standards harmonized in this sector will expedite the manufacturing and distribution of medical supplies and equipment for the provision of quality healthcare to patients, protection of healthcare staff, and the public as well as, establishing well-equipped healthcare facilities in emergency situations. Through the harmonization of African standards for pharmaceuticals and medical devices, we will contribute to  enhancing intra-African trade, reducing substandard counterfeit products, and building resilient regional health systems

The project includes the analysis of existing international, regional and national standards for their suitability to be adopted as African Standards. These will then be notified to Member States for adoption as National Standards.

In the last phase of the project, standards in this category deal with products which require substantial investments which have a long-term impact, this may include permanent facilities. While foreign standards can be utilized for interim measures, there is a need to engage with stakeholders in the manufacturing sector to adopt production practices which utilize local resources and expertise.

Harmonised product standards are critical to the implementation of the African Continental Free Trade Agreement (AfCFTA), ensuring that producers of goods in the continent comply with one shared set of minimum regulatory and customer quality requirements. In turn, this would allow them to supply the continental market and beyond with goods that meet those standards.

The initiative, which will be implemented in a phased manner over three years, begins with the harmonisation of standards for pharmaceutical products and medical devices for use in the ongoing COVID-19 pandemic. The second phase will analyse and assess existing international, regional, and national standards for their suitability in meeting the unique challenges faced by African healthcare industries. Lastly, the third phase will be the harmonisation of the related African Standards and their adoption in the continent. The initiative will also serve to enhance trade and investment within Africa’s healthcare industry by boosting the manufacture of high-quality homegrown products and services, the objectives of which are laid out within the AfCFTA.

As part of a COVID-19 response, the harmonization of standards will facilitate the development of equivalent technical regulations among African countries. Therefore, distribution of medical supplies and equipment from one country to another can be fast-tracked.

A long-term outcome of the initiative will be the emergence of regional supply chains for pharmaceutical and medical devices, which will foster an ecosystem of innovation, local production and the development of medical products for diseases that are currently neglected.

The project activities started on September 10^th 2020 by organizing working groups to agree on the way forward and the plan for 2021 in terms of procedures, engagement and regular reporting.