The Pharmacy and Poisons Board (PPB) of Kenya and the United States Food and Drug Administration (US FDA) have signed a Statement of Commitment to enhance local capacity in pharmaceutical regulation.
US FDA Associate Director for Global Policy and Strategy Mark Abdoo and PPB’s Director of Health Products and Technologies Dr. Ahmed Mohamed formalized the agreement in Nairobi on Thursday.
The event follows a confidentiality agreement signed between PPB and the US FDA in March 2024, aimed at fostering new opportunities for cooperative engagement in the pharmaceutical sector.
The US FDA delegation also visited the Ministry of Health, where they were received by Ag. Director General for Health Dr. Patrick Amoth who represented Health Cabinet Secretary Susan Nakhumicha.
Dr. Amoth emphasized the government’s Bottom-up Economic Transformation agenda, highlighting health as a key pillar of Universal Health Coverage.
“The Kenyan Government has identified Health Products and Technology as one of the four key pillars of the Universal Health Coverage under the Bottom-up Economic Transformation Agenda. Other pillars include Human Resource for Health, Healthcare Financing and Digital Health,” explained Dr. Amoth.
He said that to ensure health commodities security, Kenya supports Local Manufacturing highlighting that this is already being actualized through the establishment of the Kenya Biovax institute, and the support of the Pharmacy and Poisons Board, towards becoming a WHO- Maturity Level 3 NRA.
“A national regulatory authority that meets the WHO-ML3- has many benefits to both the local manufacturer and importer of medical products which include simplified approval processes and enhanced transparency,” said Dr. Amoth.
He added that as a result, business and local manufacturing will efficiently access markets for their commodities, therefore facilitating access to affordable, cost-effective medical products.
According to Dr. Amoth, as a key pillar toward achieving a vibrant local manufacturing environment, local manufacturers in the pharmaceutical sectors are particularly supported through the importation of active pharmaceutical ingredients and equipments for manufacturing of high-quality medicines tax free.
“The policy environment has also been changing, with the Kenya Drugs Bill No 54 of 2022, now at advanced stages of discussion in parliament; with the most recent mention being two days ago; Through this bill we anticipate the strengthening of the regulatory authority under a single roof, as the Kenya Health Products and Technologies Regulatory authority,” said Dr. Amoth.
Dr. Amoth disclosed that the Pharmacy and Poisons Board became an affiliate Member to the International Medical Devices Forum in March, and was also accepted into the Medical Devices single audit Program are both significant milestones in enhancing health system strengthening.
“The Partnership between the US FDA- and PPB which was initiated alongside the International Medical Devices Regulators forum meeting in Washington-in March this year will go a long way in supporting and strengthening the two regulatory authorities,” said Dr. Amoth.
He added: “This visit, I am also aware, is the second part where you will be solidifying the engagement, through the signing of a Statement of cooperation- further creating avenues to foster a strengthened position.”
Dr. Amoth said that Kenya is looking to incentivize further the establishment of modern manufacturing facilities and technologies, through enhancing our policies which will reduce production costs.
PPB Corporate Services Director Dr. Anthony Toroitich said that the areas of collaboration that they are looking at with US FDA include convergence of regulatory activities where they will be mentored by their counterparts from the USA so that the local inspection standards reach the top level.
Dr. Toroitich said that they will work on capacity strengthening by improving the capacity of PPB laboratories to test biological products like vaccines and other tests that they are not able to undertake currently.
“We are also looking at other areas of collaboration which include regulatory activities like registration where we do not have to undergo the process of registering a product which has already been registered in the USA; safety of medicine where we are working at strengthening our Regional Centre for Pharmacovigilance which is used to train other regional authorities in terms of how to monitor adverse reactions of medicines in the field,” said Dr. Toroitich.
He explained that BioVax will soon start manufacturing vaccines in Kenya and PPB will be looking forward to receiving coaching from US FDA on how to inspect vaccine production which is another area of supporting local manufacturing through specialized inspection.
By Joseph Ng’ang’a
