Dakar, June 28 (APS) – Senegal, while waiting to receive clearance from the World Health Organization (WHO), considers having reached “maturity level three” allowing vaccine producing countries to market their products, through the “Madiba” project, we learned from the Director General of the Agency Senegalese pharmaceutical regulation (ARP).
“Regulatory level three” also allows for international recognition, said Doctor Oumou Kalsoum Ndiaye NdaoThursday, during a day dedicated to the Senegalese Pharmaceutical Regulatory Agency (ARP), as part of the 10th edition of the International Exhibition of Medicines and Pharmaceutical Products (SENPHARMA).
This meeting is being held at the Abdou Diouf conference center in Diamniadio (CICAD), on the theme “Integrated patient care”.
The “maturity level three” reached by Senegal, in connection with the implementation of the MADIBA project, is a guarantee of the credibility of medicines, declared the director general of the Senegalese Pharmaceutical Regulatory Agency.
The “Madiba” project is an initiative aimed at self-sufficiency in vaccines in Africa and Senegal where this partnership is implemented in conjunction with the Pasteur Institute in Dakar. It involves establishing and developing a world-class workforce to support vaccine manufacturing
“We are at maturity level three through Senegal’s internal assessment. We have submitted and are awaiting full feedback from the World Health Organization to be officially declared. The WHO process is not a one-day receipt, but a process,” underlined the director of the ARP.
Senegal “is in maturity 3, because it has integrated all of its nine regulatory functions”, namely inspections, clinical trials, licensing, market surveillance.
The other functions concern the control of medicines, “the level of vigilance”, vaccines and market surveillance, according to the DG of the Senegalese Pharmaceutical Regulatory Agency.
“Maturity level three” involves several “impactful outcomes,” she says.
“The first thing for a vaccine-producing country is to market vaccines. Everything that is done within the framework of the Madiba project, with the Pasteur Institute, is supported by this maturity level 3,” explained Doctor Oumou Kalsoum Ndiaye Ndao.
The second thing, “it is the sub-regional common market which gives clearance to the credibility of the drug”, indicated the director general of the Senegalese Pharmaceutical Regulatory Agency. “When an agency is at maturity level 3, it reaches the threshold of being popularized and is recognized nationally and internationally. It’s a discharge for the country,” added Ms. Ndao.
“In 2021, we were taken out of maturity level 1 with more than 187 recommendations” about which “Senegal reacted immediately with an integrated action plan […]”. This resulted in “key recommendations on the 9 regulatory functions”, she points out.
The number of recommendations has been reduced from 2022, to a level where “we have gone to 33”, in May 2023.In December of that same year, we had only one recommendation, which consisted of returning the keys to the control laboratory which was being renovated with the bio vacci laboratory,” she continued.
Senegal’s self-assessment finally “gave a maturity level 3 out of the 9 regulatory functions”, pending “WHO confirmation on official label with report back”, said Mrs Ndao.
“Today, we are in national expertise. As I speak to you, our inspectors are in India, they are also in the sub-region to transfer our skills in terms of maturity 3”, concluded the DG of the Senegalese Pharmaceutical Regulatory Agency.
SKS/SBS/BK/ASG
