Challenges to obtain the Regulatory approval for an HIV Self-Test kit in African Countries - case study

Technical Article


  • Ana Lucia Puigvert Professional
  • Maria Zollini


This study aims at presenting how we approached the regulatory search in 26 African countries, particularly focusing on the challenges encountered and providing indication of how they were managed. The study was conducted in 2 parts: Phase I, aimed at identified the existing regulations and policies through a Regulatory survey, and Phase II, which focuses on an in-depth regulatory search for the country-specific requirements. The discussion was focused on Phase II as it was the most fruitful phase of the study and the analysis was based on the related findings. Each country was scored based on selected parameters and the results are presented in a graphical representation, where the highest score reflects the most complex, undefined, unclear and lengthy process. The complexity of the processes reflected the regulatory standpoints in each of these countries. Obtaining the approval for the HIVST kits was not eased in the countries with a more mature regulation or structured framework, as could be expected.

Author Biographies

Ana Lucia Puigvert, Professional

Bioing. Ana Lucia Puigvert. Graduated at UNER in 2008, with 10 years of experience in managing regulatory projects in an international field.

Maria Zollini

Biomed. Eng. Maria Zollini. Obtained M.Sc. degree in 2015, with two years work experience on international regulatory affairs consulting projects.






Scientific articles