Registration Harmonisation in the SADC Region
In July 2011, the SADC Secretariat finalised the Harmonisation of Medicines Registration in the SADC Region project proposal. The proposal states the overall purpose of the project as to improve public health by achieving rapid and sustainable access to safe, affordable essential medicines of acceptable quality.
The SADC project goal is to improve the availability of medicines through the regional harmonisation of regulatory systems, guidelines and processes among Member States in the SADC through:
- Harmonising the system of medicines registration and broadening the scope of products reviewed (new chemical entities, vaccines and biological) and regulatory functions undertaken (clinical trial oversight, pharmacovigilance etc.)
- Achieving political, legislative and financial support by communicating the value of the project to all stakeholders;
- Building regulatory capacity and capability
- Sharing information to facilitate faster decision making
Whilst extensive work has been done by the SADC Secretariat and its partners, SAGMA believes that there is a need for the private sector to be continuously consulted in both the planning and implementation phase of the project.
In March 2012, SAGMA convened a workshop in Botswana, where delegates had the opportunity to be briefed on the project by the different role players; engage with the SAGMA document; and implications from the perspectives of the manufacturers and wholesalers.
A SAGMA Reference Group, Chaired by Chris Chitemerere will be taking forward the outcomes of the workshop and the necessary advocacy work to ensure that industry is well positioned.