Assessment of the capacity of the Directorate of Pharmacy, Medicines and Laboratories of Cameroon to implement the regulations for obtaining the Marketing Authorization

Current status of regulations for obtaining Marketing Authorisation in Cameroon in 2024

Abstract

Introduction

Equitable access to safe, effective and quality-assured medicines is a requirement for universal health coverage. The World Health Organization reports that 10.5% of medicines on the market are substandard and falsified medicines. As part of continuous improvement, our study aimed to assess the capacity of the Department of Pharmacy, Medicines and Laboratories to implement the regulations to obtain the Marketing Authorization.

Materials and methods

 This was a descriptive cross-sectional study with a qualitative approach which took place from March 5, 2024 to March 29, 2024. The collection was carried out by a semi-structured individual interview with key personnel from the health service approval using the WHO Global  Benchmarking Tool (GBT).

Results

The assessment showed that the DPML has a functional approval system for medical products. The implementation of the 6 indicators varies from 0 to 88%. The regulatory registration and marketing function was implemented at 59% with a maturity level of 1.

Conclusion

 At the end of our study, the capacity of the DPML should be strengthened to guarantee the availability of safe, effective and quality-guaranteed medical products on its territory.