Established in 2022, the Senegalese Pharmaceutical Regulatory Agency (ARP) has quickly become a central pillar of health security in Senegal. The year 2025 marks a decisive milestone in the institution's growth, with strong operational performance, significant achievements, and increasing influence at the regional and international levels.

Robust execution and a strong capacity for adaptation

In 2025, the ARP continued the implementation of its 2024-2028 Strategic Plan in a context marked by budgetary constraints and a high operational workload. Of the 512 activities planned in its Annual Budgeted Work Plan (ABWP), 340 were completed, representing an execution rate of 66.41%. In addition, 317 unplanned activities were successfully carried out, bringing the overall completion rate to 79.25%.

This performance reflects real institutional agility, particularly in the last quarter of the year, marked by an intensification of unplanned interventions, reflecting the Agency's ability to respond quickly to health and regulatory emergencies.

Major advances in governance and quality

Institutionally, the ARP maintained its Maturity Level 3 (ML3) according to the World Health Organization (WHO) framework, confirming its alignment with international regulatory standards. The year was also marked by internal audits, participatory self-assessments, the revision of quality procedures, and the implementation of performance indicators.

An organizational and financial diagnosis carried out with the firm Ernst & Young made it possible to identify levers for improvement, preparing the Agency for the strategic ambition of reaching Maturity Level 4 (NM4) in the medium term .

A strengthened fight against illicit health products

Pharmaceutical inspection and market surveillance were among the most visible aspects of the ARP's activities in 2025. No fewer than 785 inspections were carried out in healthcare facilities and distribution channels. These operations resulted in the seizure of over 1,027 tons of illicit pharmaceutical products, representing an estimated value of 5.2 billion FCFA.

Furthermore, 187 criminal networks were dismantled, 215 people were arrested, 78 of whom were convicted, and several illegal online sales sites were shut down. These actions directly contribute to reducing health risks and strengthening public trust in the healthcare system.

Quality control: significant progress, a strategic challenge

The Directorate of Drug Quality Control analyzed 448 pharmaceutical samples in 2025. The ARP has invested in modernizing its equipment, accessing international pharmacopoeias and strengthening technical skills, particularly in microbiology and chromatography.

However, accreditation according to the ISO/IEC 17025 standard remains a major challenge. Obtaining it is a strategic priority to ensure international recognition of analytical results.

A strengthened regulatory framework and an increased territorial presence

From a legal standpoint, several key texts have been adopted, particularly concerning medical devices and hospital reform, along with a revision of the Public Health Code. These developments contribute to a more secure regulatory environment for the pharmaceutical sector.

At the same time, the ARP strengthened its territorial presence with the inauguration of the regional hubs Centre (Kaolack, Fatick, Diourbel) and North (Saint-Louis, Louga, Matam), as well as inspection and awareness missions carried out in more than ten regions of the country.

A strong international reach

The year 2025 was also marked by a strong presence of the ARP on the international stage, with 41 missions abroad, notably at major forums and initiatives such as Afrisummit, the Galien Africa Forum, and WHO initiatives. Senegal's commitment to the AMRH and WA-MRH initiatives confirms its position as a leading player in pharmaceutical regulation in Africa.

Constraints and perspectives

Despite these achievements, the ARP faces significant constraints: limited financial resources, delays in laboratory accreditation, a high operational workload, and room for improvement in inter-institutional coordination. These challenges call for increased support from the government and technical and financial partners.

The outlook for 2026 is ambitious: extension of NM3 to medical devices and vaccines, progressive preparation towards NM4, deployment of new regional hubs, acceleration of the digitalization of processes (information systems and LIMS) and strengthening of regional and global partnerships.

An institution striving for regulatory excellence

Ultimately, the 2025 exercise confirms the ARP as a key player in health security in Senegal and Africa. By combining operational rigor, responsiveness, and international openness, the Agency is laying the foundations for a more mature regulatory system, serving public health, pharmaceutical sovereignty, and the country's institutional credibility.