Medical and technical evaluation of dossiers registration is essential in ensuring the quality of goods put on the market. The list of files needed for drug regulation are as follows:
1.     Application letter for MA to the Director of Madagascar Drug Agency
2.     Summary of Product Characteristics
3.     Leaflet
4.     Administrative files
5.     Pharmaceutical, analytical, and biological files
6.     Clinical, pharmacological, and toxicological files for new active ingredients and new combinations of active ingredients
7.     Pharmacovigilance files
8.     Samples
9.     Appointment letter of the official representative in Madagascar with its coordinates. (Ministry of Public Health - Madagascar, 2016)