Developing a regionally recognised framework to support regulatory harmonisation of labelling requirements in the Southern Africa development community (SADC)

Abstract

Worldwide, medicine regulatory agencies are intentionally pursuing the concept of harmonisation or convergence of regulatory requirements across countries, Regional Economic Communities (RECs) and in some cases across continents. For Africa, the New Partnership for Africa’s Development (NEPAD), an organ of the African Union, is coordinating REC specific medicines regulatory harmonisation projects. The SADC Medicines Regulatory Harmonisation project has made significant progress. To date, registration guidelines and other technical guidelines have been published and are being adopted by member states. Following the adoption of the Zazibona process, different facets of regulatory harmonisation are being implemented, including work sharing in the form of joint dossier assessments and manufacturing facility inspections. Despite these developments, the harmonisation of medicine labelling requirements within the region has been lagging behind with ramifications on the accessibility of essential medicines for patients. A comparative analysis of the legislative and regulatory landscape within the SADC region showed that the primary barrier to harmonisation of labelling requirements was the country-specific prescribed statutory requirements which are contradictory or unique and in some cases congruent. A harmonised labelling conceptual framework is proposed which attempts to resolve the conflicting and unique requirements. A panel of experts and stakeholders reviewed the proposed concept through a prospective survey. The majority of respondents agreed in principle with the proposed framework, where concerns were raised, necessary changes were made to address queries raised in the review. All the stakeholders were agreeable to the implementation of the proposal as an interim measure while changes to regulations are being considered. These changes to regulations were estimated to be achievable in less than four years. Given the potential impact of harmonising labelling requirements on public health, control of pharmaceutical products and accessibility of essential medicines, the SADC secretariat may use the outcome of this study for wider engagement within SADC member states to expedite harmonisation of labelling requirements.