Senegal is still awaiting the deliberation of the World Health Organization (WHO) for maturity three (3) which allows the country to produce vaccines and be able to market them internationally. According to the Director General of the Pharmaceutical Regulatory Agency (Arp), Dr Oumou Kalsoum Ndao Ndiaye, Senegal has met all WHO criteria. She spoke yesterday, Thursday June 27, 2024, during the International Medicines Fair, organized by Senpharma.
Obtaining maturity 3 by Senegal caused a cacophony in the heads of several Senegalese. For several days, health stakeholders and at the highest level, the responsible minister, have been popularizing Senegal’s achievement of this level of maturity. An achievement which allows the country to be able to produce vaccines and market them internationally. The Director of the Pharmaceutical Regulatory Agency (Arp), Dr Oumou Kalsoum Ndao Ndiaye, who coordinates the actions of this maturity, gave some answers yesterday, Thursday June 27, 2024, during the International Medicines Fair.
According to Dr. Oumou Kalsoum Ndao Ndiaye, Senegal is still waiting for this certification. To this end, she informed that in 2021, Senegal was on an evaluation test of its regulatory system, with more than 187 recommendations.It’s a whole process that has been there since 2021. In December 2023, we exhausted all the recommendations. Self-assessment gives maturity level three in Senegal with zero recommendations and nine level three functions” she made it clear. And added: “but the process is that when the country completes its assessment, WHO sends experts to come and verify it. It is an angle of analysis in relation to a vision».
For Dr. Oumou Kalsoum, what emerged from the assessment from April 28 to May 4 is that out of the nine (9) regulatory functions, seven (7) were at maturity level three (3), namely inspections, the clinic, the system overall, licensing, market surveillance, drug control. Today, the only point awaiting validation remains vaccines, which is the eighth function that obtained maturity 3, but Senegal is expected on production.The Pasteur Institute in Dakar must trigger the production of Madiba, which is scheduled for the end of July, so that new data can be submitted. Because the data on which we carried out the analysis were those from 2019. The Pasteur Institute had stopped manufacturing. So, we are suspending this maturity level 3 on vaccines and we are waiting for production from the Pasteur Institute“, said the Director of the ARP.
And to add: “the level of vigilance for pharmacovigilance remained a recommendation that needed to be supplemented. Which means that, of the 9 regulatory functions today, we have submitted all of them, because the process had to continue. On May 4, we had to complete the vigilance. We have submitted it and we are awaiting the complete return from the WHO officially declared».
On the internal evaluation of Senegal, Dr Ndao Ndiaye also supports: “We are at maturity level 3 on our 9 regulatory functions. WHO accreditation is not a one-day receipt, but a process. If the minister says that we are at maturity 3, we are. But, we are waiting for confirmation from WHO on the official label with a return report. Today, we are in national expertise. As I speak to you, our inspectors are in India, are in the sub-region to transfer our skills in terms of maturity 3“, she said.
Today, Senegal has integrated all of its regulatory functions. What remains is obtaining clearance from the WHO which involves several results including the production of vaccines. “When an Agency is at maturity level 3, it reaches the threshold of being popularized and recognized nationally and internationally”she says.
DENISE ZAROUR MEDANG
