Registration of health products for human use: Niger Republic case (from January 2018 to December 2020)

Abstract

Objective: Our study aims to make a nomenclature of the pharmaceutical products having received an authorization of sale on the market (MA) in Niger Republic and to describe the profiles of the various applicant laboratories and or manufacturers. We had conducted a retrospective and descriptive study on new applications for registration of health products for human use examined in first intention only by the National Commission for Health Products Approval (NCHPA) from January 2018 to December 2020.
 Material and methods: Over this period, 7 sessions of the NCHPA were held, including 3 in 2018, 2 in 2019, and 2 in 2020. In total, 951 dossiers for registration were reviewed in first intention.
 Results: It was found that the majority of applicant laboratories (37.22%) as well as manufacturer laboratories (40.38%) were from India. The most represented therapeutic class was antibiotics (21.35%) followed by antimalarial (9.67%). However, the main route of administration was oral (79.28%) with a predominance of tablets (52.47%). Our study had also noted that only 10.10% of the dossiers have been accepted against 86.75% postponed due to lack of required information.
 Summary ad conclusion: The national drug nomenclature remains the main document guiding the prescription and dispensing of products with a valid market authorization in the country. This is why all the actors in pharmaceutical logistics must have at hand all the information on the products approved in Niger.